The Effectiveness of Cognitive-Functional Remote Group Intervention (Cog-Fun RG) for Adults with Attention Deficit Hyperactivity Disorder (ADHD) (ADHD)

October 11, 2024 updated by: Adina Maeir, Hebrew University of Jerusalem

The goal of this clinical trial is to examine the effectiveness of Cognitive-Functional Remote Group intervention (Cog-Fun RG).

The main questions of this study are 1. will participants demonstrate improvements in their executive functioning and quality of life after receiving the intervention, compared to waitlist controls. In addition, the investigators will examine if the waitlist group will demonstrate similar gains in these outcomes after receiving the same intervention.

the investigators will compare between the intervention group to the waiting list group to examine the effect of the intervention.

The participants will be allocated into two groups: an intervention group and a waiting list group.

The intervention group will receive the the Cog-Fun RG intervention, which includes 21 weekly group sessions, each lasting 90 minutes. the participants will be required to complete questionnaires at several time points: pre-post the intervention, as well as three months, six months, and one year after the intervention.

The waiting list controls will be required to complete questionnaires at several time points: pre-post waiting period, and then after the intervention, as well as three months, six months, and one year after the intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

* Self Reported ADHD diagnoses

Exclusion Criteria:

* Self Reported other major health condition that impedes daily functioning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CogFun RG occupational therapy
Occupational Therapy Remote Group Intervention . 21 weekly, online group sessions (4-6 participants in each group), lasting 90 minutes. Sessions are structured, comprising opening, collaborative learning, and summary. Session topics include learning about ADHD as a biological disorder of executive functioning, understanding the impact of ADHD on daily life, discovering strategies for coping with ADHD through exploration of life experiences, and preparing for future self-management.
Behavioral: CogFun RG occupational therapy
21 weekly, online group sessions (4-6 participants in each group), lasting 90 minutes. Sessions are structured, comprising opening, collaborative learning, and summary. Session topics include learning about ADHD as a biological disorder of executive functioning, understanding the impact of ADHD on daily life, discovering strategies for coping with ADHD through exploration of life experiences, and preparing for future self management
No Intervention: Waitlist Control Group
Waiting list, no intervention. After waitlist period will receive the same intervention as the first arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adult ADHD quality of life scale
Time Frame: at baseline, immediately after the intervention, immediately after the waiting period and 3 months after the intervention follow up
Questionnaire with 29 questions relating to productivity, life outlook, relationships and psychological health. each question is rated on a 5 point scale. Raw scores are transformed to a 1-100 scale. higher scores indicate higher quality of life. The assessment will be conducted at baseline, immediately after the intervention, immediately after the waiting period and 3 months after the intervention follow up.
at baseline, immediately after the intervention, immediately after the waiting period and 3 months after the intervention follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Rating Inventory of Executive Functions (BRIEF) Adult Self -Report
Time Frame: at baseline, immediately after the intervention, immediately after the waiting period.
Self-report questionnaire for adults evaluates Executive Functions (EF) in everyday contexts. Comprising 75 items rated on a three-point scale (1 = never, 2 = occasionally, 3 = often), the questionnaire categorizes items into nine scales representing distinct EF domains, along with two primary indices. The first, the Behavioral Regulation Index (BRI), encompasses inhibition, shifting, emotional regulation, and behavioral monitoring. The second, the Metacognitive Index (MI), includes working memory, initiation, planning/organization, task monitoring, and organization of materials. These indices contribute to a composite summary score known as the Global Executive Composite (GEC). raw scores are transposed to T-scores based on norms. The assessment will be conducted pre-post the intervention. Higher scores indicating greater difficulty with EF; a score of 65 or above signifies clinical impairment.
at baseline, immediately after the intervention, immediately after the waiting period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebrew University of Jerusalem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10032020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

currently we do not have such a plan we will be happy to consider this in the future

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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