Organizational Skills Training for Children With ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Organizational Skills Training for Children With ADHD

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Organizational skills training
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD diagnosis after clinical interview K-SADS age between 6-13 years, both inclusive; informed consent. The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills. Exclusion Criteria: autism spectrum disorder serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior) head injury or verified neurological disease intelligence quotient (IQ <80) medical condition, requiring primary treatment no informed consent from custody.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training | Behavioral: Organizational skills training<br>* 10 sessions of parent and child training in a group format.<br>Other: Treatment as usual<br>* Treatment as usual in the outpatient clinic<br>|
| Other: Control<br>Control participants will receive treatment as usual. | Other: Treatment as usual<br>* Treatment as usual in the outpatient clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children Organizational Skills Scale (COSS)-parent | organizational skills questionnaire | after 10 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |