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Clinical Trials/NCT02681575
NCT02681575
Completed
N/A

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

Hadassah Medical Organization1 site in 1 country14 target enrollmentMarch 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Hadassah Medical Organization
Enrollment
14
Locations
1
Primary Endpoint
Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
January 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)

Time Frame: 3-4 months

Self rating questionnaire targeting executive functions in daily life

Secondary Outcomes

  • Canadian Occupational Performance Measure(3-4 months)
  • Adult ADHD Quality of Life Scale (AaQoL)(3-4 months)

Study Sites (1)

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