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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681575
• Other study ID #: 0658-15-HMO
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: February 21, 2018
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Cog-Fun - A
Meta-cognitive functional intervention for improved self management in adults with ADHD

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Mount Scopus	Jerusalem	Yerushalayim

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)	Self rating questionnaire targeting executive functions in daily life	3-4 months
Secondary	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
Secondary	Canadian Occupational Performance Measure	structured interview administered by occupational therapist	3-4 months