Attention Deficit DisorderNCT05096975
Personality Profile of Children and Adolescents With ADHD and With or Without Emotional Dysregulation
An observational study of Attention Deficit Disorder and Emotional Dysfunction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder, Emotional Dysfunction
- What is being tested?
- Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 30 Dec 2021
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: * Children with a diagnostic of ADHD and followed at Montpellier University Hospital. * Children and adolescents aged between 7 and 12 years.
Who may be able to join
- Children and adolescents aged 7-12 years followed at Montpellier University Hospital ;
- Children and adolescents with a diagnostic of ADHD (diagnostics criteria from DSM-V);
- Children and adolescents benefiting from a multidisciplinary evaluation or therapeutic group at the child psychiatry unit of Montpellier University Hospital
Who cannot join
- Family non-french speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Personality Profile of Children and Adolescents With Attention Deficit Hyperactive Disorder (ADHD) With or Without Emotional Dysregulation
Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli.
According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood .
Read more
ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED.
The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories.
The second objectives are:
- Improve understanding of the heterogeneity of ADHD symptom expression;
- Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
- Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.
- Conditions
- Attention Deficit Disorder, Emotional Dysfunction
- Being tested
- Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED
- Keywords
- Personality traits, Children, Attention Deficit Hyperactivity Disorder, Emotion dysregulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without EDOther
The intervention involves the completion of two questionnaires by parents at child psychiatry unit of Montpellier University Hospital when children come to participate in a psychometric assessment or when parents or children participate in therapeutic group.
All parents completed Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2001), a 118-item questionnaire to measure emotional and behavior problems in 4 to 18-years-old children in the past six months and Hierarchical Personality Inventory for Children (HiPIC, Mervielde \& De Fruyt, 1999, a 144-item questionnaire to obtain a profile of the personality of 6 to 12-year-old children.
| Study group | Role | What they receive |
|---|---|---|
| Control group | ADHD without emotion dysregulation (Control group) The group is composed of children with ADHD and with a score ≤ 180 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. Receives: Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED | |
| Deficit Emotion Self Regulation group | ADHD without moderate emotion dysregulation (Deficit Emotion Self Regulation group) The group is composed of children with ADHD and with a score ≥180 and ≤ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. Receives: Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED | |
| Dysregulation Profile Group | ADHD with severe emotion dysregulation (Dysregulation Profile Group) The group is composed of children with ADHD and with a score ≥ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. Receives: Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Score at the CBCL-A-A-A
Score at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales (Achenbach \& Rescorla, 2001).
Questionnaire measures emotional and behavior problem in 4 to 18 year-old children in the past months.
Measured: 1 day
Secondary outcomes (1)
Rate of Score of Hierachical Personality Inventory for Childen
Score of Hierachical Personality Inventory for Childen (HiPIC, Mervielde \& De Fruyt, 1999), 144-item questionnaire to obtain a profile of the personality
Questionnaire obtains a profile of personality of 6 to 12 year-old children.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Purper-Ouakil, M.D., Ph. D., Study director, UH MontpellierRomo, PHD, Study director, University Paris Nanterre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096975
- Sponsor's protocol ID
- RECHMPL20_0524
- Status last verified
- Apr 2022
- First submitted
- 18 Oct 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Personality Profile of Children and Adolescents With Attention Deficit Hyperactive Disorder (ADHD) With or Without Emotional Dysregulation
- ClinicalTrials.gov ID
- NCT05096975
- Acronym / sponsor ID
- RECHMPL20_0524
- Conditions
- Attention Deficit Disorder, Emotional Dysfunction
- Keywords
- Personality traits, Children, Attention Deficit Hyperactivity Disorder, Emotion dysregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Oct 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.
Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli.
According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood .
ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED.
The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories.
The second objectives are:
- Improve understanding of the heterogeneity of ADHD symptom expression;
- Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
- Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without EDADHD without emotion dysregulation (Control group) The group is composed of children with ADHD and with a score ≤ 180 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. |
| Deficit Emotion Self Regulation group | – | Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without EDADHD without moderate emotion dysregulation (Deficit Emotion Self Regulation group) The group is composed of children with ADHD and with a score ≥180 and ≤ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. |
| Dysregulation Profile Group | – | Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without EDADHD with severe emotion dysregulation (Dysregulation Profile Group) The group is composed of children with ADHD and with a score ≥ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- * Children with a diagnostic of ADHD and followed at Montpellier University Hospital. * Children and adolescents aged between 7 and 12 years.
Key inclusion criteria (3 listed)
- Children and adolescents aged 7-12 years followed at Montpellier University Hospital ;
- Children and adolescents with a diagnostic of ADHD (diagnostics criteria from DSM-V);
- Children and adolescents benefiting from a multidisciplinary evaluation or therapeutic group at the child psychiatry unit of Montpellier University Hospital
Key exclusion criteria (1 listed)
- Family non-french speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without EDThe intervention involves the completion of two questionnaires by parents at child psychiatry unit of Montpellier University Hospital when children come to participate in a psychometric assessment or when parents or children participate in therapeutic group. All parents completed Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2001), a 118-item questionnaire to measure emotional and behavior problems in 4 to 18-years-old children in the past six months and Hierarchical Personality Inventory for Children (HiPIC, Mervielde \& De Fruyt, 1999, a 144-item questionnaire to obtain a profile of the personality of 6 to 12-year-old children. | Other | Control group, Deficit Emotion Self Regulation group, Dysregulation Profile Group |
Primary outcome
Rate of Score at the CBCL-A-A-A
Time frame: 1 day
Score at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales (Achenbach \& Rescorla, 2001). Questionnaire measures emotional and behavior problem in 4 to 18 year-old children in the past months.
1 secondary outcome
Rate of Score of Hierachical Personality Inventory for Childen
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Attention Deficit Disorder
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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.
Diane Purper-Ouakil, M.D., Ph. D. study director
UH Montpellier
Romo, PHD study director
University Paris Nanterre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder and Emotional Dysfunction, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Score at the CBCL-A-A-A (time frame: 1 day). 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 14 Apr 2022.