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The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.
Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training |
|
| Control | Other | Control participants will receive treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organizational skills training | Behavioral | 10 sessions of parent and child training in a group format. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children Organizational Skills Scale (COSS)-parent | organizational skills questionnaire | after 10 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Children Organizational Skills Scale (COSS)-teacher | organizational skills questionnaire | after 10 weeks of intervention |
| ADHD-Rating Scale (ADHD-RS) (parent edition) | ADHD symptoms questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior Rating Inventory of Executive Functions (BRIEF)-teacher | executive functions questionnaire | after 10 weeks of intervention |
| CANTAB Stop Signal Task (SST) | cognitive test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aida Bikic, Ph.D. | Contact | +45 29168216 | aida.bikic@rsyd.dk | |
| Søren Dalsgaard, MD, Ph.D. | Contact | sdalsgaard@econ.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Aida Bikic, Ph.D. | Region of Southern Denmark and University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Child and Adolescent Mental Health Services | Recruiting | Aabenraa | 6200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34715906 | Derived | Bikic A, Dalsgaard S, Olsen KD, Sukhodolsky DG. Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial. Trials. 2021 Oct 29;22(1):752. doi: 10.1186/s13063-021-05499-9. |
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After the competition of the study, data will be stored in Danish National Archives, where data can be accessed after previous approval.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Other | Treatment as usual in the outpatient clinic |
|
| after 10 weeks of intervention |
| Behavior Rating Inventory of Executive Functions (BRIEF)-parent | executive functions questionnaire | after 10 weeks of intervention |
| CANTAB Rapid Visual Movement (RVP) | cognitive test | after 10 weeks of intervention |
| Weis's scale of disability-Parent Report (WFIRS-P) | functional outcome questionnaire | after 10 weeks of intervention |
| after 10 weeks of intervention |
| CANTAB one touch Stockings of Cambridge (SOC) | cognitive test | after 10 weeks of intervention |
| CANTAB Working Memory (WM) | cognitive test | after 10 weeks of intervention |
| Non-serious adverse events | adverse events | after 10 weeks of intervention |
| Serious adverse events | adverse events | after 10 weeks of intervention |
| Children Organizational Skills Scale (COSS)-parent | organizational skills questionnaire | 24 weeks after ended intervention |
| Children Organizational Skills Scale (COSS)-teacher | organizational skills questionnaire | 24 weeks after ended intervention |
| ADHD-Rating Scale (ADHD-RS) (parent edition) | ADHD symptoms questionnaire | 24 weeks after ended intervention |
| ADHD-Rating Scale (ADHD-RS) (teacher edition) | ADHD symptoms questionnaire | 24 weeks after ended intervention |
| Behavior Rating Inventory of Executive Functions (BRIEF)-parent | executive functions questionnaire | 24 weeks after ended intervention |
| Behavior Rating Inventory of Executive Functions (BRIEF)-teacher | executive functions questionnaire | 24 weeks after ended intervention |
| CANTAB Stop Signal Task (SST) | cognitive test | 24 weeks after ended intervention |
| CANTAB one touch Stockings of Cambridge (SOC) | cognitive test | 24 weeks after ended intervention |
| CANTAB Rapid Visual Movement (RVP) | cognitive test | 24 weeks after ended intervention |
| CANTAB Working Memory (WM) | cognitive test | 24 weeks after ended intervention |
| Weis's scale of disability-Parent Report (WFIRS-P) | functional outcome questionnaire | 24 weeks after ended intervention |
| Non-serious adverse events | adverse events | 24 weeks after ended intervention |
| Serious adverse events | adverse events | 24 weeks after ended intervention |
| CANTAB Reaction time task (RTI) | reaction time | after 10 weeks of intervention |
| CANTAB Reaction time task (RTI) | reaction time | after 24 weeks of intervention |
| ADHD-Rating Scale (ADHD-RS) (teacher edition) | ADHD symptoms questionnaire | after 10 weeks of intervention |
| Department of Child and Adolescent Mental Health Services | Recruiting | Vejle | Denmark |
|