Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD

Study Overview
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Brief Summary
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Scientific Rationale: Many children with ADHD have serious difficulties in participation in daily occupations in their ecological settings. These difficulties have a pervasive negative impact on their everyday functioning and quality of life (QoL). Although pharmacological treatment has been proven effective in treating ADHD symptoms in many children, as have psychosocial interventions such as parent training, there is little evidence for integrative approaches that address the cognitive, volitional and social-environmental barriers to participation with this population. Although preliminary positive effects of a cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been demonstrated, additional evidence is needed to confirm these initial findings. Methods: Initial results of our pilot study (N=17 children with ADHD) demonstrated significant moderate to large effects of Cog-Fun treatment, which targeted participation and executive functions in daily life. Significant effects were also found for a measure of self-efficacy and neuropsychological measures of attention, planning and organization. Parent ratings showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current study is to replicate the pilot study findings in a randomized controlled trial. The study will be a randomized controlled trial with a crossover design, including 2 groups of children with ADHD attending elementary school and their parents. The research group (Group A, n=50) will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the control group (Group B, n=50) will be wait-listed and receive treatment after three months. Outcomes will include measures of participation, executive functions in daily life, child and parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant main effect of time (pre-post intervention), group (research vs. control) and a significant interaction effect (group x time) on executive and occupational outcome measures.

Official Title
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COG FUN Intervention for ADHD

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: COG - FUN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of ADHD 7-10 years old regular education system no moderate or severe neurological and/or psychiatric disorders Exclusion Criteria: moderate or severe neurological and/or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control waitlist<br> | Behavioral: COG - FUN<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADHD parameters | Using Brief Questionnaire | Three assessment points - at recruitment, after 3 months and after 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age 7-10 years old, regular education system, no moderate or severe neurological and/or psychiatric disorders