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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Cog-Fun - A

• Registration Number: NCT02681575
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Study Start: 2016-03
• Status Verified: 2016-09
• Primary Completion: 2017-07
• Study Completion: 2018-01
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cog-Fun A	Cog-Fun - A	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.

Primary Outcome Measures

Name	Time	Method
Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)	3-4 months	Self rating questionnaire targeting executive functions in daily life

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization, Mount Scopus; 🇮🇱 Jerusalem, Yerushalayim, Israel