Meta-cognitive Functional Intervention for Adults With ADHD: A Pilot Efficacy Study

Study Overview
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Brief Summary
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The purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD). It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate improvements in measures of executive functioning, occupational performance and quality of life.

Detailed Description
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The Cog-Fun - A is a structured occupational therapy intervention for promoting self management in adults with ADHD. The protocol comprises three central treatment modules: Adaptive self awareness, executive strategies and skill implementation and multi-context transfer of strategies and skills. The intervention is administered by occupational therapists on an individual basis, once a week, over 3-4 months. 20 participants will be recruited through community advertising. Sample size was determined based on expected moderate effect sizes. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods. Adverse events if occur will be reported to supervising psychiatrist and the Helsinki Committee.

Official Title
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Meta-cognitive Functional Intervention for Adults (Cog-Fun - A) With Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Efficacy Study

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Cog-Fun - A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD diagnosed by certified medical practitioner Adult ADHD Self Report Scale (ASRS) score above cutoff BRIEF-A score above cutoff Exclusion Criteria: Diagnoses of severe neurological or psychiatric health condition. Instability in pharmacological treatment Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cog-Fun A<br>Metacognitive-Functional occupational therapy intervention (Cog-Fun - A) includes enhancing self awareness in occupational context, acquiring executive strategies and skills and implementation across multiple occupational domains. | Behavioral: Cog-Fun - A<br>* Meta-cognitive functional intervention for improved self management in adults with ADHD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Ratings of Executive Functions - Adult version (BRIEF-A) | Self rating questionnaire targeting executive functions in daily life | 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Quality of Life Scale (AaQoL) | Self rating questionnaire targeting the impact of ADHD on Life Productivity, Psychological Health, Relationships and Life outlook | 3-4 months | 
| Canadian Occupational Performance Measure | structured interview administered by occupational therapist | 3-4 months |