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NCT Number: NCT06639139

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Self Reported ADHD diagnoses

Exclusion criteria

  • Self Reported other major health condition that impedes daily functioning

Treatment and study plan

CogFun RG occupational therapy

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adina Prof. Maeir, PhD

CONTACT

[email protected]

972 546205081

Ruthi Dr Traub Bar Ilan, PhD

CONTACT

[email protected]

972 544990500

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Registry information

Acronym: ADHD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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