Comorbid ConditionsNF ADHDNCT01252446
Children With ADHD Symptoms: Comorbid Conditions, Cognitive and Social Performance
An observational study of Comorbid Conditions and Social-demographic Profiles, run by University of Bergen at 1 site in Norway.
Trial summary
This article reviews social-demographic variables (SDV) including interpersonal and academic and social performance in families and comorbid conditions(CC) which are the most associated with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed diagnosis of ADHD and sample with the same… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Comorbid Conditions, Social-demographic Profiles
- How many people
- 187 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Dec 2010
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: One hundred eihgty seven children and adolescent referred to a Child and Adolescent Mental Health Clinic in Haugesund, Rogaland, Norway with the sympthoms of innattentivity, hyperactivity and impulsivity. Ninety one of them has been diagnosed with ADHD by the ICD 10 Classification and Diagnostic system and ninety six has been diagnised with other diagnosis accordning to ICD 10 classification . All referred children has been evaluated in this study. The diagnosis was made by child psychiatrist and relevant team and was based on the standard somatic and mental examination, information from the parents and teachers and diagnostics interviews.(Clinicians manual for assessment and parent training from Russell A. Barkley and SDQ-nor questionnaire ).
Who may be able to join
- clinical symptoms related on diagnosis of ADHD
- age from 6-17 years
Who cannot join
- retardation
- somatic disorder
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Child and Adolescent Psychiatry Clinic Helse Fonna Haugesund
Haugesund, Rogaland, 5500
Tove Vågen, CCORDINATOR, 004752732800, Tove.Iversen.Vagen@helse-fonna.no
Nezla Duric, M.D., 004790544231, nezlad@gmail.com
About this study
This article reviews social-demographic variables (SDV) including interpersonal and academic and social performance in families and comorbid conditions(CC) which are the most associated with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.
There are no reports of this kind in the Norwegian population with ADHD.
Read the detailed description
ADHD is one of the largest diagnostic groups in psychiatric health care for children and adolescents in Norway. In the guidelines laid out by the central authorities, ADHD is to be prioritized. As can be seen by the attention this topic is given in the media, good diagnostics and treatment for this group are important for society as well as the individuals who suffer from this. Early diagnosis, proper organization and appropriate treatment have a positive effect on the self-esteem and development of the person diagnosed as well as probable socio-economic benefits for society.
ADHD population shows significant pattern in socio-demographic relations and comorbidity according to the population that is referred to community Mental Health Clinic due another types of psychiatric conditions.
In terms of comorbid states ODD and OCD are most associated with ADHD . The study indicates prevalence of ADHD children (74%) who met criteria for ADHD, Combined Type (ADHD-C, both inattention and hyperactivity-impulsivity symptoms) and the existence of generally low IQ measures with mean value of 85 points. In terms of comorbid states generally were found in almost whole ADHD group (93 %) compared to half of the non-ADHD group. Disruptive Behaviour Disorder, Anxiety /Stress related disorder and Encopresis /Enuresis shows significant difference between the groups. Other comorbid conditions show no significant differences. Social dysfunctions were found in four of five children.
- Conditions
- Comorbid Conditions, Social-demographic Profiles
- Keywords
- ICD 10, Attention-Deficit-Hyperactivity-Disorder (ADHD), Comorbidity, Social-demographic profile
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD | The sample of 187 children and adolescent in the age of 6 to 17 years referred to the Child and Adolescent Clinic, Haugesund, Norway during the period of one year and diagnosed in ICD 10 system as ADHD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6)
The population was selected from a specialized outpatient clinic for Child and Adolescent Mental Health in Norway. ADHD referred children were classified in two groups: ADHD and non-ADHD. The data was obtained by examination of children and adolescent and by personal interviews and questionnaire with parents, teachers, children and adolescent with attention-deficit/hyperactivity disorder (ADHD).
Measured: 1 year
Secondary outcomes (1)
cognitive performance
Wechsler Intelligence Scale for Children-Revised (WISC-R)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Comorbid ConditionsStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna
- Investigators
- Irene Elgen, m.d.PhD, Study chair, University in BergenNezla Duric, M.D., Principal investigator, University in Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252446
- Sponsor's protocol ID
- 219.04 REK
- Other IDs
- 219.04(REK)
- Acronym
- NF ADHD
- Status last verified
- Jan 2009
- First submitted
- 19 Nov 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen PS, Hinshaw SP, Kraemer HC, Lenora N, Newcorn JH, Abikoff HB, March JS, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. ADHD comorbidity findings from the MTA study: comparing comorbid subgroups. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):147-58. doi: 10.1097/00004583-200102000-00009.
PubMed 11211363Pliszka SR. Psychiatric comorbidities in children with attention deficit hyperactivity disorder: implications for management. Paediatr Drugs. 2003;5(11):741-50. doi: 10.2165/00148581-200305110-00003.
PubMed 14580223da Silva MA, Louza MR, Vallada HP. Attention deficit hyperactivity disorder (ADHD) in adults: social-demographic profile from a university hospital ADHD outpatient unit in Sao Paulo, Brazil. Arq Neuropsiquiatr. 2006 Sep;64(3A):563-7. doi: 10.1590/s0004-282x2006000400004.
PubMed 17119791Duric NS, Assmus J, Gundersen D, Elgen IB. Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. BMC Psychiatry. 2012 Aug 10;12:107. doi: 10.1186/1471-244X-12-107.
PubMed 22877086
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With ADHD Symptoms: Comorbid Conditions, Cognitive and Social Performance
- ClinicalTrials.gov ID
- NCT01252446
- Acronym / sponsor ID
- NF ADHD / 219.04 REK
- Conditions
- Comorbid Conditions, Social-demographic Profiles
- Keywords
- ICD 10, Attention-Deficit-Hyperactivity-Disorder (ADHD), Comorbidity, Social-demographic profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse Fonna
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Dec 2010 (estimated)
- 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.
This article reviews social-demographic variables (SDV) including interpersonal and academic and social performance in families and comorbid conditions(CC) which are the most associated with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.
There are no reports of this kind in the Norwegian population with ADHD.
Detailed description
ADHD is one of the largest diagnostic groups in psychiatric health care for children and adolescents in Norway. In the guidelines laid out by the central authorities, ADHD is to be prioritized. As can be seen by the attention this topic is given in the media, good diagnostics and treatment for this group are important for society as well as the individuals who suffer from this. Early diagnosis, proper organization and appropriate treatment have a positive effect on the self-esteem and development of the person diagnosed as well as probable socio-economic benefits for society.
ADHD population shows significant pattern in socio-demographic relations and comorbidity according to the population that is referred to community Mental Health Clinic due another types of psychiatric conditions.
In terms of comorbid states ODD and OCD are most associated with ADHD . The study indicates prevalence of ADHD children (74%) who met criteria for ADHD, Combined Type (ADHD-C, both inattention and hyperactivity-impulsivity symptoms) and the existence of generally low IQ measures with mean value of 85 points. In terms of comorbid states generally were found in almost whole ADHD group (93 %) compared to half of the non-ADHD group. Disruptive Behaviour Disorder, Anxiety /Stress related disorder and Encopresis /Enuresis shows significant difference between the groups. Other comorbid conditions show no significant differences. Social dysfunctions were found in four of five children.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | –The sample of 187 children and adolescent in the age of 6 to 17 years referred to the Child and Adolescent Clinic, Haugesund, Norway during the period of one year and diagnosed in ICD 10 system as ADHD. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One hundred eihgty seven children and adolescent referred to a Child and Adolescent Mental Health Clinic in Haugesund, Rogaland, Norway with the sympthoms of innattentivity, hyperactivity and impulsivity. Ninety one of them has been diagnosed with ADHD by the ICD 10 Classification and Diagnostic system and ninety six has been diagnised with other diagnosis accordning to ICD 10 classification . All referred children has been evaluated in this study. The diagnosis was made by child psychiatrist and relevant team and was based on the standard somatic and mental examination, information from the parents and teachers and diagnostics interviews.(Clinicians manual for assessment and parent training from Russell A. Barkley and SDQ-nor questionnaire ).
Key inclusion criteria (2 listed)
- clinical symptoms related on diagnosis of ADHD
- age from 6-17 years
Key exclusion criteria (2 listed)
- retardation
- somatic disorder
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
Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6)
Time frame: 1 year
The population was selected from a specialized outpatient clinic for Child and Adolescent Mental Health in Norway. ADHD referred children were classified in two groups: ADHD and non-ADHD. The data was obtained by examination of children and adolescent and by personal interviews and questionnaire with parents, teachers, children and adolescent with attention-deficit/hyperactivity disorder (ADHD).
1 secondary outcome
cognitive performance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Background: PubMed 11211363Jensen PS, Hinshaw SP, Kraemer HC, Lenora N, Newcorn JH, Abikoff HB, March JS, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. ADHD comorbidity findings from the MTA study: comparing comorbid subgroups. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):147-58. doi: 10.1097/00004583-200102000-00009.
- Background: PubMed 14580223Pliszka SR. Psychiatric comorbidities in children with attention deficit hyperactivity disorder: implications for management. Paediatr Drugs. 2003;5(11):741-50. doi: 10.2165/00148581-200305110-00003.
- Background: PubMed 17119791da Silva MA, Louza MR, Vallada HP. Attention deficit hyperactivity disorder (ADHD) in adults: social-demographic profile from a university hospital ADHD outpatient unit in Sao Paulo, Brazil. Arq Neuropsiquiatr. 2006 Sep;64(3A):563-7. doi: 10.1590/s0004-282x2006000400004.
- Derived from this study: PubMed 22877086Duric NS, Assmus J, Gundersen D, Elgen IB. Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. BMC Psychiatry. 2012 Aug 10;12:107. doi: 10.1186/1471-244X-12-107.
- MTA studyLink provided by the sponsor.
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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.
Irene Elgen, m.d.PhD study chair
University in Bergen
Nezla Duric, M.D. principal investigator
University in Bergen
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 Comorbid Conditions and Social-demographic Profiles, run by University of Bergen at 1 site 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 2 inclusion and 2 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 3 Dec 2010. 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 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?
Contact Nezla Duric, M:D: (004790544231, nezlad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252446, which also lists 4 linked publications.
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 3 Dec 2010.