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Completed

NCT Number: NCT02681575

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization, Mount Scopus

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cog-Fun - A

Behavioral

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

Primary outcomes

  1. 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

  1. Adult ADHD Quality of Life Scale (AaQoL)

    Time frame: 3-4 months

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

  2. Canadian Occupational Performance Measure

    Time frame: 3-4 months

    structured interview administered by occupational therapist

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 12, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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