Disruptive Mood Dysregulation DisorderNCT05049356
Symptoms and Mechanisms of Child Psychiatric Disorders
An observational study of Disruptive Mood Dysregulation Disorder and Attention Deficit Hyperactivity Disorder, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric clinics. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder
- How many people
- 218 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Sep 2019to Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Parents of children referred to outpatient psychiatric service (The Department of Child and Adolescent Psychiatry at Oslo University Hospital, and Nic Waals Institute at Lovisenberg Hospital) will be informed about the study and asked to participate.
Who may be able to join
- Referred to outpatient psychiatric service
- Intelligence quotient (IQ) within normal range
- Child and parents: Good enough understanding of Norwegian language to give valid answers in interview and tests.
- Clarified care situation
Who cannot join
- IQ below normal range
- Child and parents: Not good enough understanding of Norwegian language to give valid answers in interview and tests
- Unclarified care situation
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Child and Adolescent Psychiatry, Oslo University Hospital
Oslo
Nic Waals Institute, Lovisenberg Hospital
Oslo
About this study
Official title: Associated Symptoms, Underlying Mechanisms and Parental Factors of Child Psychiatric Disorders With Focus on Severe Irritability.
In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric clinics. A specific focus will be given to children suffering from severe irritability.
Read the detailed description
In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric service. A specific focus will be given to children suffering from severe irritability making problems at home, in school, and/or with peers.
Disruptive Mood Dysregulation Disorder (DMDD) is characterized by chronic and severe irritability and anger in children. DMDD understood as severe or clinical irritability can be regarded as laying above a certain threshold on a irritability continuum. Due to DMDD being a relatively new and debated diagnosis there is an urgent need to gain better understanding of the underlying mechanisms of severe irritability in children.
This study will explore emotion and behavior symptoms, neuropsychological functions (including social perception), perceived parental stress and attachment styles, and cortisol levels of children and their mothers, in children referred to outpatient psychiatric service including children with severe irritability. Parents of children 6 to 12 years will be informed and asked to participate.
The work on severe irritability will be divided into six main areas:
- Severe irritability in a Norwegian clinical population: prevalence, comorbidity and associated difficulties
- Social and emotional understanding in severe irritability in children
- Executive function in severe irritability in children
- Stress response in severe irritability in children
- Parental stress and attachment style in parents of severe irritability in children
- DMDD: An affective or conduct disorder? Comparing anxiety and depressive symptoms
- Conditions
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Severe Irritability, Child Psychiatric Disorders
- Keywords
- Neuropsychology, Neurocognition, Executive function, Social cognition, Mentalization, Affect recognition, Stress, Cortisol, Parental Stress, Attachment, Behavior symptoms, Emotion symptoms
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children referred to outpatient clinic | Diagnostic interview (Schedule for Affective Disorders and Schizophrenia (K-SADS) cf. Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) with parents. Diagnostic groups/cohorts (e.g., DMDD, ADHD, Oppositional Defiant Disorder) will be based on the diagnoses given cf. K-SADS. | |
| Typical developing children and their parent(s) | Norm values on hair cortisol data will be obtained from typical developing children and their parent(s) by the same procedure as described under Outcome measure(s), 21. Stress Response by Cortisol levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Perception by task performance: Affect Recognition
Affect Recognition, a subtest from the Developmental Neuropsychological Assessment (NEPSY®) Second Edition, will be used to measure facial affect recognition. In brief, higher scores means better recognition ability and vice versa:
Total raw score:
- 6 years old children: 4 (minimum) - 25 (maximum).
- 7-12 years old children: 12 (min.) - 35 (max.).
Raw scores are converted to scaled scores by Pearson's NEPSY-2 machine based scoring tool. Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Measured: Baseline
Social Perception by task performance: Theory of Mind
Theory of Mind, a subtest from the NEPSY® Second Edition, will be used to measure the ability to understand that others have different thoughts, feelings and experiences than oneself. In brief, higher scores means better theory of mind ability and vice versa:
Total raw score for 6-12 years old children: 0 (min.) - 28 (max.). Total Verbal raw score: 0 (min.) - 22 (max.). Raw scores are converted to percentiles* by Pearson's NEPSY-2 machine based scoring tool.
*For scores with nonnormal distributions (i.e., underlying distribution were highly skewed), raw scores are converted to percentile ranks (instead of scaled scores).
Measured: Baseline
Executive function by task performance: Verbal Working Memory
Word List Interference, a subtest from the NEPSY® Second Edition, will be used to measure Verbal Memory Span and Verbal Working Memory which are important executive functions.
Scores for 7 to 12 years old children (not applicable to 6 years old):
- Repetition (WIRP)Total Score: 0 (min.) - 20 (max.).
- Recall (WIRC) Total Score: 0 (min.) - 40 (max.).
Raw scores are converted to scaled scores* by Pearson's NEPSY-2 machine based scoring tool. Lower vs. higher scores on WIRP or WIRC means more limited vs. better Verbal Memory Span or Verbal Working Memory, respectively.
*Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Measured: Baseline
Executive function by task performance: Inhibitory Control
Inhibition, a subtests from the NEPSY® Second Edition, will be used to measure Inhibitory Control which is an important executive function. Scaled scores are calculated by Pearson's NEPSY-2 machine based scoring tool.
In brief, a low Inhibition-Inhibition Combined Scaled Score* indicate poor Inhibitory Control, and a low Inhibition-Switching Combined Scaled Score* indicate poor Inhibitory Control and Cognitive Flexibility.
The Inhibition-Inhibition Combined Scaled Score integrates error rate and time (i.e., raw score Inhibition-Inhibition Total Errors and Completion Time) with an emphasis on accuracy of performance over speed. .
*Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Measured: Baseline
Executive function by task performance: Cognitive Flexibility
Inhibition, a subtests from the NEPSY® Second Edition, will be used to measure Inhibitory Control and Cognitive Flexibility which are important executive functions. Scaled scores are calculated by Pearson's NEPSY-2 machine based scoring tool.
In brief, a low Inhibition-Switching Combined Scaled Score* indicate poor Inhibitory Control and Cognitive Flexibility.
The Inhibition-Switching Combined Scaled Score integrates error rates and time (i.e., raw score Inhibition-Switching Total Errors Completion Time) with more weight given on accuracy than speed.
*Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Measured: Baseline
Executive function by task performance: non-verbal Cognitive Flexibility
Design Fluency, a subtests from the NEPSY® Second Edition, will be used to measure Executive Function including non-verbal Cognitive Flexibility.
Total raw score for 6 to 12 years old children: 0 (min.) - 70 (max.). Raw scores are converted to scaled scores* by Pearson's NEPSY-2 machine based scoring tool.
In brief, higher scores scores means better non-verbal Cognitive Flexibility and Executive Function, and vice versa.
*Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Measured: Baseline
Executive function by report: Inhibitory control
Inhibitory control will be measured using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2; parent- and teacher-report) Inhibit Index. Items are converted from BRIEF to BRIEF-2 (cf. BRIEF-2 does not include additional items). Raw scores are calculated to t-scores according to the Psychological Assessment Resources' (PAR) BRIEF-2 manual. Higher scores mean worse ability to control impulses. T Scores ≥ 65 are regarded as in the clinical range.
References:
Gioia, G. A., Isquith, P. K., Guy, S. C., \& Kenworthy, L. (2000). Behavior rating inventory of executive function professional manual. Odessa: FL: Psychological Assessment Resources.
Gioia, G. A., Isquith, P. K., Guy, S. C., \& Kenworthy, L. (2015). Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2). Lutz, FL: PAR Inc.
Measured: Baseline
Executive function by report: Cognitive flexibility
Cognitive flexibility (e.g., the ability to tolerate change and switch or alternate attention) will be measured using the BRIEF-2's Shift Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores mean worse ability to tolerate change and switch or alternate attention. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Emotional Control
Emotional control will be measured using the BRIEF-2's Emotional Control Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse emotional control. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Initiate
The ability to begin an activity and to independently generate ideas or problem-solving strategies will be measured using the BRIEF-2's Initiate Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to initiate actions. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Working Memory
Working memory capacity will be measured using the BRIEF-2's Working Memory Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse working memory. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Plan/Organize
Ability to plan/organize will be measured using the BRIEF-2's Plan/Organize Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to plan/organize. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Organization of Materials
Ability to organize materials will be measured using the BRIEF-2's Organization of Materials Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to organize materials. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Task-Monitor
The ability to task-monitor (i.e., the ability to noticing minor errors in work output) will be measured using the BRIEF-2's Task-Monitor Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to task-monitor. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Self-Monitor
The ability to self-monitor (i.e., the awareness of the impact of one's own behavior on other people and outcomes) will be measured using the BRIEF-2's Self-Monitor Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to self-monitor. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Overall executive function by report
The childrens' overall executive function will be measured using the BRIEF-2's Global Executive Composite (Total Score). Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse executive function. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Behavior Regulation
The childrens' ability to regulate and monitor their behavior effectively will be measured using the BRIEF-2's Behavior Regulation Index (BRI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse behavior regulation. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Emotion Regulation
The childrens' ability to regulate their emotions will be measured using the BRIEF-2's Emotion Regulation Index (ERI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse emotion regulation. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Executive function by report: Cognitive Regulation
The childrens' ability to control and manage cognitive processes and problem solve effectively will be measured using the BRIEF-2's Cognitive Regulation Index (CRI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse cognitive regulation. T Scores ≥ 65 are regarded as in the clinical range.
Measured: Baseline
Perceived Parenting Stress by report
Parental stress and stressful aspects of parent-child interaction will be measured by the Parenting Stress Index (PSI; parent-report).
Results by the following PSI Indexes will be reported:
- Child Subscale. Values: 47 (min.) - 235 (max.)
- Parent Subscale. Values: 54 (min.) - 270 (max.)
- Total Stress Scale. Values: 101 (min.) - 505 (max.)
- Life Stress. Values: 0 (min.) - 79 (max.)
Raw scores to percentiles calculation will be done using Psychological Assessment Resources' (PAR) PSI score sheet. The percentiles will be divided in the following categories: percentiles ≤ 19, percentiles between 20 and 50, percentiles between 51 and 84, and percentiles ≥ 85. Higher scores and percentiles means more distress and vice versa.
Measured: Baseline
Stress Response by Cortisol levels
Stress Response in children and their mothers will be measured by Hair Cortisol Concentrations:
1st cm from the scalp of children and their mothers. Indicate hair cortisol concentrations from the last month (approximately).
Measured: Baseline
Attachment style in parents by report
The Relationships Questionnaire (RQ; Bartholomew \& Horowitz, 1991) will be used to measure four attachment styles in parents. Parents are asked to rate their degree of correspondence (7-point scale) to each attachment prototype described in RQ. The minimum value is 1 ("Disagree strongly") and the maximum value is 7 ("Agree strongly") which indicate how well or poorly each attachment style corresponds to the parent's general relationship style.
Measured: Baseline
Withdrawn and Depressed Symptoms by report
The Syndrome Scale Withdrawn/Depressed from the Achenbach Systems of Empirically Based Assessment (ASEBA; Norwegian Version) for children 6-18 years by parent- and teacher-report will be used to measure withdrawn and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Anxious and Depressed Symptoms by report
The Syndrome Scale Anxious/Depressed from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxious and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Somatic Complaints by report
The Syndrome Scale Somatic Complaints from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxious and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Social Problems by report
The Syndrome Scale Social Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure social problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical social problems, a t-score between 65 and 69 indicates that the child is at risk for clinical social problems, and a t-score ≥ 70 indicates clinical social problems.
Measured: Baseline
Thought Problems by report
The Syndrome Scale Thought Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure thought problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical thought problems, a t-score between 65 and 69 indicates that the child is at risk for clinical thought problems, and a t-score ≥ 70 indicates clinical thought problems.
Measured: Baseline
Attention Problems by report
The Syndrome Scale Attention Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure attention problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical attention problems, a t-score between 65 and 69 indicates that the child is at risk for clinical attention problems, and a t-score ≥ 70 indicates clinical attention problems.
Measured: Baseline
Rule-Breaking Behavior by report
The Syndrome Scale Rule-Breaking Behavior from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure rule-breaking behavior. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical rule-breaking behavior, a t-score between 65 and 69 indicates that the child is at risk for clinical rule-breaking behavior, and a t-score ≥ 70 indicates clinical rule-breaking behavior.
Measured: Baseline
Aggressive Behavior by report
The Syndrome Scale Aggressive Behavior from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure aggressive behavior. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical aggressive behavior, a t-score between 65 and 69 indicates that the child is at risk for clinical aggressive behavior, and a t-score ≥ 70 indicates clinical aggressive behavior.
Measured: Baseline
Internalizing problems by report
Internalizing problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Internalizing Problems Scale Score combine the the following Syndrome Scales Scores: Anxious/Depressed, Withdrawn/Depressed, and Somatic Complaints. Higher scores means worse symptom level. T-scores from the Internalizing Problems Scale will be calculated using a computer based program. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Measured: Baseline
Externalizing problems by report
Externalizing problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Externalizing Problems Scale Score combine the the following Syndrome Scales Scores: Rule-Breaking Behavior and Aggressive Behavior. T-scores from the Externalizing Problems Scale will be calculated using a computer based program. Higher scores means worse symptom level. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Measured: Baseline
Total behavior and emotional problems by report
Total behavior and emotional problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Total Problems Scale Score combine the total Syndrome Scales Scores. This includes the following syndrome scales in addition to those included in the Internalizing and Externalizing Problems Scales: Social Problems, Thought Problems, and Attention Problems. T-scores from the Total Problems Scale will be calculated using a computer based program. Higher scores means worse symptom level. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Measured: Baseline
Affective Symptoms by report
The DSM-Oriented Scale Affective Problems of the ASEBA for children 6-18 years by parent- and teacher-report will be used to measure affective symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms. The DSM-5 oriented symptoms by ASEBA includes:
Measured: Baseline
Anxiety Symptoms by report
The DSM-Oriented Scale Anxiety Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxiety symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Somatic Problems by report
The DSM-Oriented Scale Somatic Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure somatic problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Attention Deficit/Hyperactivity Symptoms by report
The DSM-Oriented Scale Attention Deficit/Hyperactivity Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure attention deficit/hyperactivity symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Oppositional Defiant Symptoms by report
The DSM-Oriented Scale Oppositional Defiant Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure oppositional defiant Symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Conduct Problems by report
The DSM-Oriented Scale Conduct Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure conduct problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Measured: Baseline
Irritability by report
The following items of the ASEBA for children 6-18 years by parent- and teacher report will be used to measure irritability symptoms on a continous scale: 86. Stubborn, Sullen, or Irritable, 87. Sudden mood changes, and 95. Temper tantrums or hot temper. Each item is rated on the same 0-1-2 Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. Minimum value is 0 and Maximum value is 6. Higher scores means more irritability and vice versa.
Measured: Baseline
Dysregulation by report
Degree of emotional and behavioral dysregulation is computed by summing up the T-scores for the syndrome scales Anxiety/Depression, Attention Problems, and Aggression Problems (AAA profile) in ASEBA. Higher t-score means higher degree of dysregulation and vice versa. T scores equal to or above 210 means severe dysregulation.
Measured: Baseline
Global Functioning
Children's Global Assessment Scale is a numeric scale (ranging from 1 to 100) measuring the general functioning of children. Higher scores means better functioning and vice versa.
Measured: Baseline
Follow-up (6 months): Disruptive Mood Dysregulation Disorder
Children meeting criteria for Disruptive Mood Dysregulation Disorder (DMDD) at baseline will be examined after 6 months using the K-SADS screening and additional interview for DMDD to check if they still meet criteria for DMDD.
Measured: Follow-up at 6 months
Follow-up (12 months): Diagnosis
All participants will be examined after 12 months using the K-SADS to check if they still meet the criteria for a diagnosis.
Measured: Follow-up at 12 months
Follow-up (12 months): Symptoms
The same scales from the ASEBA as examined at baseline will be used similarly to measure symptom levels after 12 months.
Measured: Follow-up at 12 months
Affective Interpretation Bias
Items examination of NEPSY-2 Affect Recognition targeting face-emotion interpretation bias.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Sep 2019
- Primary completion9 Aug 2021
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Mood Dysregulation DisorderStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 218 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Pål Zeiner, Oslo University Hospital
- Investigators
- Pål Zeiner, PhD, Study director, Head of Child Psychiatric Research at Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049356
- Sponsor's protocol ID
- 2017/135
- Status last verified
- Apr 2023
- First submitted
- 17 Jun 2021
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data are on patients. We need to decide whether or not anonymous data can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Symptoms, Underlying Mechanisms and Parental Factors of Child Psychiatric Disorders With Focus on Severe Irritability.
- ClinicalTrials.gov ID
- NCT05049356
- Acronym / sponsor ID
- 2017/135
- Conditions
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Severe Irritability, Child Psychiatric Disorders
- Keywords
- Neuropsychology, Neurocognition, Executive function, Social cognition, Mentalization, Affect recognition, Stress, Cortisol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Linkoeping University, Lovisenberg Diakonale Hospital
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric clinics. A specific focus will be given to children suffering from severe irritability.
Detailed description
In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric service. A specific focus will be given to children suffering from severe irritability making problems at home, in school, and/or with peers.
Disruptive Mood Dysregulation Disorder (DMDD) is characterized by chronic and severe irritability and anger in children. DMDD understood as severe or clinical irritability can be regarded as laying above a certain threshold on a irritability continuum. Due to DMDD being a relatively new and debated diagnosis there is an urgent need to gain better understanding of the underlying mechanisms of severe irritability in children.
This study will explore emotion and behavior symptoms, neuropsychological functions (including social perception), perceived parental stress and attachment styles, and cortisol levels of children and their mothers, in children referred to outpatient psychiatric service including children with severe irritability. Parents of children 6 to 12 years will be informed and asked to participate.
The work on severe irritability will be divided into six main areas:
- Severe irritability in a Norwegian clinical population: prevalence, comorbidity and associated difficulties
- Social and emotional understanding in severe irritability in children
- Executive function in severe irritability in children
- Stress response in severe irritability in children
- Parental stress and attachment style in parents of severe irritability in children
- DMDD: An affective or conduct disorder? Comparing anxiety and depressive symptoms
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children referred to outpatient clinic | – | –Diagnostic interview (Schedule for Affective Disorders and Schizophrenia (K-SADS) cf. Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) with parents. Diagnostic groups/cohorts (e.g., DMDD, ADHD, Oppositional Defiant Disorder) will be based on the diagnoses given cf. K-SADS. |
| Typical developing children and their parent(s) | – | –Norm values on hair cortisol data will be obtained from typical developing children and their parent(s) by the same procedure as described under Outcome measure(s), 21. Stress Response by Cortisol levels. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of children referred to outpatient psychiatric service (The Department of Child and Adolescent Psychiatry at Oslo University Hospital, and Nic Waals Institute at Lovisenberg Hospital) will be informed about the study and asked to participate.
Key inclusion criteria (4 listed)
- Referred to outpatient psychiatric service
- Intelligence quotient (IQ) within normal range
- Child and parents: Good enough understanding of Norwegian language to give valid answers in interview and tests.
- Clarified care situation
Key exclusion criteria (3 listed)
- IQ below normal range
- Child and parents: Not good enough understanding of Norwegian language to give valid answers in interview and tests
- Unclarified care situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Social Perception by task performance: Affect Recognition
Time frame: Baseline
Affect Recognition, a subtest from the Developmental Neuropsychological Assessment (NEPSY®) Second Edition, will be used to measure facial affect recognition. In brief, higher scores means better recognition ability and vice versa: Total raw score: * 6 years old children: 4 (minimum) - 25 (maximum). * 7-12 years old children: 12 (min.) - 35 (max.). Raw scores are converted to scaled scores by Pearson's NEPSY-2 machine based scoring tool. Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Social Perception by task performance: Theory of Mind
Time frame: Baseline
Theory of Mind, a subtest from the NEPSY® Second Edition, will be used to measure the ability to understand that others have different thoughts, feelings and experiences than oneself. In brief, higher scores means better theory of mind ability and vice versa: Total raw score for 6-12 years old children: 0 (min.) - 28 (max.). Total Verbal raw score: 0 (min.) - 22 (max.). Raw scores are converted to percentiles* by Pearson's NEPSY-2 machine based scoring tool. *For scores with nonnormal distributions (i.e., underlying distribution were highly skewed), raw scores are converted to percentile ranks (instead of scaled scores).
Executive function by task performance: Verbal Working Memory
Time frame: Baseline
Word List Interference, a subtest from the NEPSY® Second Edition, will be used to measure Verbal Memory Span and Verbal Working Memory which are important executive functions. Scores for 7 to 12 years old children (not applicable to 6 years old): 1. Repetition (WIRP)Total Score: 0 (min.) - 20 (max.). 2. Recall (WIRC) Total Score: 0 (min.) - 40 (max.). Raw scores are converted to scaled scores* by Pearson's NEPSY-2 machine based scoring tool. Lower vs. higher scores on WIRP or WIRC means more limited vs. better Verbal Memory Span or Verbal Working Memory, respectively. *Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Executive function by task performance: Inhibitory Control
Time frame: Baseline
Inhibition, a subtests from the NEPSY® Second Edition, will be used to measure Inhibitory Control which is an important executive function. Scaled scores are calculated by Pearson's NEPSY-2 machine based scoring tool. In brief, a low Inhibition-Inhibition Combined Scaled Score* indicate poor Inhibitory Control, and a low Inhibition-Switching Combined Scaled Score* indicate poor Inhibitory Control and Cognitive Flexibility. The Inhibition-Inhibition Combined Scaled Score integrates error rate and time (i.e., raw score Inhibition-Inhibition Total Errors and Completion Time) with an emphasis on accuracy of performance over speed. . *Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Executive function by task performance: Cognitive Flexibility
Time frame: Baseline
Inhibition, a subtests from the NEPSY® Second Edition, will be used to measure Inhibitory Control and Cognitive Flexibility which are important executive functions. Scaled scores are calculated by Pearson's NEPSY-2 machine based scoring tool. In brief, a low Inhibition-Switching Combined Scaled Score* indicate poor Inhibitory Control and Cognitive Flexibility. The Inhibition-Switching Combined Scaled Score integrates error rates and time (i.e., raw score Inhibition-Switching Total Errors Completion Time) with more weight given on accuracy than speed. *Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Executive function by task performance: non-verbal Cognitive Flexibility
Time frame: Baseline
Design Fluency, a subtests from the NEPSY® Second Edition, will be used to measure Executive Function including non-verbal Cognitive Flexibility. Total raw score for 6 to 12 years old children: 0 (min.) - 70 (max.). Raw scores are converted to scaled scores* by Pearson's NEPSY-2 machine based scoring tool. In brief, higher scores scores means better non-verbal Cognitive Flexibility and Executive Function, and vice versa. *Converted scaled scores have a mean of 10, a standard deviation of 3, and a range from 1-19.
Executive function by report: Inhibitory control
Time frame: Baseline
Inhibitory control will be measured using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2; parent- and teacher-report) Inhibit Index. Items are converted from BRIEF to BRIEF-2 (cf. BRIEF-2 does not include additional items). Raw scores are calculated to t-scores according to the Psychological Assessment Resources' (PAR) BRIEF-2 manual. Higher scores mean worse ability to control impulses. T Scores ≥ 65 are regarded as in the clinical range. References: Gioia, G. A., Isquith, P. K., Guy, S. C., \& Kenworthy, L. (2000). Behavior rating inventory of executive function professional manual. Odessa: FL: Psychological Assessment Resources. Gioia, G. A., Isquith, P. K., Guy, S. C., \& Kenworthy, L. (2015). Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2). Lutz, FL: PAR Inc.
Executive function by report: Cognitive flexibility
Time frame: Baseline
Cognitive flexibility (e.g., the ability to tolerate change and switch or alternate attention) will be measured using the BRIEF-2's Shift Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores mean worse ability to tolerate change and switch or alternate attention. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Emotional Control
Time frame: Baseline
Emotional control will be measured using the BRIEF-2's Emotional Control Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse emotional control. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Initiate
Time frame: Baseline
The ability to begin an activity and to independently generate ideas or problem-solving strategies will be measured using the BRIEF-2's Initiate Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to initiate actions. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Working Memory
Time frame: Baseline
Working memory capacity will be measured using the BRIEF-2's Working Memory Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse working memory. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Plan/Organize
Time frame: Baseline
Ability to plan/organize will be measured using the BRIEF-2's Plan/Organize Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to plan/organize. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Organization of Materials
Time frame: Baseline
Ability to organize materials will be measured using the BRIEF-2's Organization of Materials Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to organize materials. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Task-Monitor
Time frame: Baseline
The ability to task-monitor (i.e., the ability to noticing minor errors in work output) will be measured using the BRIEF-2's Task-Monitor Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to task-monitor. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Self-Monitor
Time frame: Baseline
The ability to self-monitor (i.e., the awareness of the impact of one's own behavior on other people and outcomes) will be measured using the BRIEF-2's Self-Monitor Index. Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse ability to self-monitor. T Scores ≥ 65 are regarded as in the clinical range.
Overall executive function by report
Time frame: Baseline
The childrens' overall executive function will be measured using the BRIEF-2's Global Executive Composite (Total Score). Items are converted from BRIEF to BRIEF-2. Raw scores are calculated to t-scores according to the PAR BRIEF-2 manual. Higher scores means worse executive function. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Behavior Regulation
Time frame: Baseline
The childrens' ability to regulate and monitor their behavior effectively will be measured using the BRIEF-2's Behavior Regulation Index (BRI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse behavior regulation. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Emotion Regulation
Time frame: Baseline
The childrens' ability to regulate their emotions will be measured using the BRIEF-2's Emotion Regulation Index (ERI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse emotion regulation. T Scores ≥ 65 are regarded as in the clinical range.
Executive function by report: Cognitive Regulation
Time frame: Baseline
The childrens' ability to control and manage cognitive processes and problem solve effectively will be measured using the BRIEF-2's Cognitive Regulation Index (CRI). BRIEF scores are converted to BRIEF-2 scores as BRIEF-2 consists of no new items. Raw scores are calculated to T Scores according to the PAR BRIEF-2 scoring manual. Higher scores means worse cognitive regulation. T Scores ≥ 65 are regarded as in the clinical range.
Perceived Parenting Stress by report
Time frame: Baseline
Parental stress and stressful aspects of parent-child interaction will be measured by the Parenting Stress Index (PSI; parent-report). Results by the following PSI Indexes will be reported: * Child Subscale. Values: 47 (min.) - 235 (max.) * Parent Subscale. Values: 54 (min.) - 270 (max.) * Total Stress Scale. Values: 101 (min.) - 505 (max.) * Life Stress. Values: 0 (min.) - 79 (max.) Raw scores to percentiles calculation will be done using Psychological Assessment Resources' (PAR) PSI score sheet. The percentiles will be divided in the following categories: percentiles ≤ 19, percentiles between 20 and 50, percentiles between 51 and 84, and percentiles ≥ 85. Higher scores and percentiles means more distress and vice versa.
Stress Response by Cortisol levels
Time frame: Baseline
Stress Response in children and their mothers will be measured by Hair Cortisol Concentrations: 1st cm from the scalp of children and their mothers. Indicate hair cortisol concentrations from the last month (approximately).
Attachment style in parents by report
Time frame: Baseline
The Relationships Questionnaire (RQ; Bartholomew \& Horowitz, 1991) will be used to measure four attachment styles in parents. Parents are asked to rate their degree of correspondence (7-point scale) to each attachment prototype described in RQ. The minimum value is 1 ("Disagree strongly") and the maximum value is 7 ("Agree strongly") which indicate how well or poorly each attachment style corresponds to the parent's general relationship style.
Withdrawn and Depressed Symptoms by report
Time frame: Baseline
The Syndrome Scale Withdrawn/Depressed from the Achenbach Systems of Empirically Based Assessment (ASEBA; Norwegian Version) for children 6-18 years by parent- and teacher-report will be used to measure withdrawn and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Anxious and Depressed Symptoms by report
Time frame: Baseline
The Syndrome Scale Anxious/Depressed from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxious and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Somatic Complaints by report
Time frame: Baseline
The Syndrome Scale Somatic Complaints from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxious and depressed, i.e., internalizing, symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Social Problems by report
Time frame: Baseline
The Syndrome Scale Social Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure social problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical social problems, a t-score between 65 and 69 indicates that the child is at risk for clinical social problems, and a t-score ≥ 70 indicates clinical social problems.
Thought Problems by report
Time frame: Baseline
The Syndrome Scale Thought Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure thought problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical thought problems, a t-score between 65 and 69 indicates that the child is at risk for clinical thought problems, and a t-score ≥ 70 indicates clinical thought problems.
Attention Problems by report
Time frame: Baseline
The Syndrome Scale Attention Problems from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure attention problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical attention problems, a t-score between 65 and 69 indicates that the child is at risk for clinical attention problems, and a t-score ≥ 70 indicates clinical attention problems.
Rule-Breaking Behavior by report
Time frame: Baseline
The Syndrome Scale Rule-Breaking Behavior from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure rule-breaking behavior. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical rule-breaking behavior, a t-score between 65 and 69 indicates that the child is at risk for clinical rule-breaking behavior, and a t-score ≥ 70 indicates clinical rule-breaking behavior.
Aggressive Behavior by report
Time frame: Baseline
The Syndrome Scale Aggressive Behavior from the ASEBA (6-18 years by parent- and teacher-report) will be used to measure aggressive behavior. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical aggressive behavior, a t-score between 65 and 69 indicates that the child is at risk for clinical aggressive behavior, and a t-score ≥ 70 indicates clinical aggressive behavior.
Internalizing problems by report
Time frame: Baseline
Internalizing problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Internalizing Problems Scale Score combine the the following Syndrome Scales Scores: Anxious/Depressed, Withdrawn/Depressed, and Somatic Complaints. Higher scores means worse symptom level. T-scores from the Internalizing Problems Scale will be calculated using a computer based program. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Externalizing problems by report
Time frame: Baseline
Externalizing problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Externalizing Problems Scale Score combine the the following Syndrome Scales Scores: Rule-Breaking Behavior and Aggressive Behavior. T-scores from the Externalizing Problems Scale will be calculated using a computer based program. Higher scores means worse symptom level. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Total behavior and emotional problems by report
Time frame: Baseline
Total behavior and emotional problems will be assessed with parent- and teacher-report using the ASEBA for children 6-18 years. The Total Problems Scale Score combine the total Syndrome Scales Scores. This includes the following syndrome scales in addition to those included in the Internalizing and Externalizing Problems Scales: Social Problems, Thought Problems, and Attention Problems. T-scores from the Total Problems Scale will be calculated using a computer based program. Higher scores means worse symptom level. A t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms.
Affective Symptoms by report
Time frame: Baseline
The DSM-Oriented Scale Affective Problems of the ASEBA for children 6-18 years by parent- and teacher-report will be used to measure affective symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms. The DSM-5 oriented symptoms by ASEBA includes:
Anxiety Symptoms by report
Time frame: Baseline
The DSM-Oriented Scale Anxiety Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure anxiety symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Somatic Problems by report
Time frame: Baseline
The DSM-Oriented Scale Somatic Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure somatic problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Attention Deficit/Hyperactivity Symptoms by report
Time frame: Baseline
The DSM-Oriented Scale Attention Deficit/Hyperactivity Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure attention deficit/hyperactivity symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Oppositional Defiant Symptoms by report
Time frame: Baseline
The DSM-Oriented Scale Oppositional Defiant Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure oppositional defiant Symptoms. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Conduct Problems by report
Time frame: Baseline
The DSM-Oriented Scale Conduct Problems of the ASEBA (6-18 years by parent- and teacher-report) will be used to measure conduct problems. Raw scores will be calculated to T-scores using a computer based program. Higher scores means worse symptom level. A t-score ≤ 64 indicates non-clinical symptoms, a t-score between 65 and 69 indicates that the child is at risk for clinical symptoms, and a t-score ≥ 70 indicates clinical symptoms.
Irritability by report
Time frame: Baseline
The following items of the ASEBA for children 6-18 years by parent- and teacher report will be used to measure irritability symptoms on a continous scale: 86. Stubborn, Sullen, or Irritable, 87. Sudden mood changes, and 95. Temper tantrums or hot temper. Each item is rated on the same 0-1-2 Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. Minimum value is 0 and Maximum value is 6. Higher scores means more irritability and vice versa.
Dysregulation by report
Time frame: Baseline
Degree of emotional and behavioral dysregulation is computed by summing up the T-scores for the syndrome scales Anxiety/Depression, Attention Problems, and Aggression Problems (AAA profile) in ASEBA. Higher t-score means higher degree of dysregulation and vice versa. T scores equal to or above 210 means severe dysregulation.
Global Functioning
Time frame: Baseline
Children's Global Assessment Scale is a numeric scale (ranging from 1 to 100) measuring the general functioning of children. Higher scores means better functioning and vice versa.
Follow-up (6 months): Disruptive Mood Dysregulation Disorder
Time frame: Follow-up at 6 months
Children meeting criteria for Disruptive Mood Dysregulation Disorder (DMDD) at baseline will be examined after 6 months using the K-SADS screening and additional interview for DMDD to check if they still meet criteria for DMDD.
Follow-up (12 months): Diagnosis
Time frame: Follow-up at 12 months
All participants will be examined after 12 months using the K-SADS to check if they still meet the criteria for a diagnosis.
Follow-up (12 months): Symptoms
Time frame: Follow-up at 12 months
The same scales from the ASEBA as examined at baseline will be used similarly to measure symptom levels after 12 months.
Affective Interpretation Bias
Time frame: Baseline
Items examination of NEPSY-2 Affect Recognition targeting face-emotion interpretation bias.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Regional Committees for Medical and Health Research Ethics ApprovalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data are on patients. We need to decide whether or not anonymous data can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Zeiner, PhD study director
Head of Child Psychiatric Research at Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disruptive Mood Dysregulation Disorder and Attention Deficit Hyperactivity Disorder, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Perception by task performance: Affect Recognition (time frame: Baseline). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.