NCT06639139

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 6, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

Occupational TherapyExecutive FunctionsRemote Group Therapy

Outcome Measures

Primary Outcomes (1)

  • The adult ADHD quality of life scale

    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 Outcomes (1)

  • Behavioral Rating Inventory of Executive Functions (BRIEF) Adult Self -Report

    at baseline, immediately after the intervention, immediately after the waiting period.

Study Arms (2)

CogFun RG occupational therapy

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

Waiting list, no intervention. After waitlist period will receive the same intervention as the first arm

Interventions

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

CogFun RG occupational therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \* Self Reported ADHD diagnoses

You may not qualify if:

  • \* Self Reported other major health condition that impedes daily functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University

Jerusalem, Israel

RECRUITING

Related Publications (2)

  • Galili-Simhon S, Maeir A. Cognitive Functional Remote Group intervention for adults with attention deficit hyperactivity disorder: A feasibility study. Br J Occup Ther. 2023 Oct;86(10):686-696. doi: 10.1177/03080226231177842. Epub 2023 Jun 5.

    PMID: 40337196BACKGROUND
  • Kastner L, Velder-Shukrun Y, Bonne O, Bar-Ilan RT, Maeir A. Pilot Study of the Cognitive-Functional Intervention for Adults (Cog-Fun A): A Metacognitive-Functional Tool for Adults With Attention Deficit Hyperactivity Disorder. Am J Occup Ther. 2022 Mar 1;76(2):7602205070. doi: 10.5014/ajot.2022.046417.

    PMID: 35258515BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Adina Prof. Maeir, PhD

CONTACT

Ruthi Dr Traub Bar Ilan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Adina Maeir, School of Occupational Therapy, Hebrew University

Study Record Dates

First Submitted

October 6, 2024

First Posted

October 15, 2024

Study Start

November 1, 2024

Primary Completion

October 1, 2025

Study Completion

February 1, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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

Locations