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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Cog-Fun - A

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hadassah Medical Organization, Mount Scopus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cog-Fun A

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Self rating questionnaire targeting executive functions in daily life

Secondary Outcome Measures

Adult ADHD Quality of Life Scale (AaQoL)

Self rating questionnaire targeting the impact of ADHD on Life Productivity, Psychological Health, Relationships and Life outlook

Canadian Occupational Performance Measure

structured interview administered by occupational therapist

Full Information

NCT ID

NCT02681575

First Posted

February 10, 2016

Last Updated

February 21, 2018

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT02681575

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cog-Fun A

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cog-Fun - A

Intervention Description

Meta-cognitive functional intervention for improved self management in adults with ADHD

Primary Outcome Measure Information:

Title

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

Description

Self rating questionnaire targeting executive functions in daily life

Time Frame

3-4 months

Secondary Outcome Measure Information:

Title

Adult ADHD Quality of Life Scale (AaQoL)

Description

Self rating questionnaire targeting the impact of ADHD on Life Productivity, Psychological Health, Relationships and Life outlook

Time Frame

3-4 months

Title

Canadian Occupational Performance Measure

Description

structured interview administered by occupational therapist

Time Frame

3-4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omer Bonne, MD

Organizational Affiliation

HMO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization, Mount Scopus

City

Jerusalem

State/Province

Yerushalayim

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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