NCT02681575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 22, 2018

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

February 10, 2016

Last Update Submit

February 21, 2018

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

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

    Self rating questionnaire targeting executive functions in daily life

    3-4 months

Secondary Outcomes (2)

  • Adult ADHD Quality of Life Scale (AaQoL)

    3-4 months

  • Canadian Occupational Performance Measure

    3-4 months

Study Arms (1)

Cog-Fun A

EXPERIMENTAL

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.

Behavioral: Cog-Fun - A

Interventions

Cog-Fun - ABEHAVIORAL

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

Cog-Fun A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ADHD diagnosed by certified medical practitioner
  • Adult ADHD Self Report Scale (ASRS) score above cutoff
  • BRIEF-A score above cutoff

You may not qualify if:

  • Diagnoses of severe neurological or psychiatric health condition.
  • Instability in pharmacological treatment
  • Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Mount Scopus

Jerusalem, Jerusalem, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Omer Bonne, MD

    HMO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

February 22, 2018

Record last verified: 2016-09

Locations

IL(1)