ClinicalTrials.gg
RecruitingNCT06639139ADHDUpdated Oct 15, 2024

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

An interventional study of CogFun RG occupational therapy in ADHD, sponsored by Hebrew University of Jerusalem. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Hebrew University of Jerusalem · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel — 9 open to participants now, 10 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Israel.

Planned enrollment
37th of 61
40 · median 46
Started
2024
with 5 others
No phase
38 of 85
6 open now
Registered
80th of 85
by date

Among the 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel, this one is the 37th largest by planned enrollment of the 61 interventional ones that give a count, is one of 6 that started in 2024, is one of 38 with no phase, and was the 80th registered.

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

Browse Attention Deficit Disorder with Hyperactivity studies →

Open to participants now

9 of the 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • ADHD

Keywords

  • Occupational Therapy
  • Executive Functions
  • Remote Group Therapy
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

* Self Reported ADHD diagnoses

Exclusion criteria

Exclusion Criteria:

* Self Reported other major health condition that impedes daily functioning

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    Waitlist Control Group

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

Interventions

  • BehavioralCogFun 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

06

What researchers measure

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.

    Time frame: 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

    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.

    Time frame: at baseline, immediately after the intervention, immediately after the waiting period.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Galili-Simhon, Shoval, and Adina Maeir. "Cognitive Functional Remote Group intervention for adults with attention deficit hyperactivity disorder: A feasibility study." British Journal of Occupational Therapy 86.10 (2023): 686-696.
  • 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. PubMed 35258515 ↗

Individual participant data

Plan to share: No — currently we do not have such a plan we will be happy to consider this in the future

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Oct 2025, 11 months later.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 11 months is below that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2024
First posted
Oct 15, 2024
StartEst.
Nov 2024
Primary completionEst.
Oct 2025
CompletionEst.
Feb 2026
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06639139
Lead sponsor
Hebrew University of Jerusalem
Responsible party
Adina Maeir (Prof. Adina Maeir, School of Occupational Therapy, Hebrew University, Hebrew University of Jerusalem) — Principal investigator
First posted
Oct 15, 2024
Start date
Nov 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Feb 2026 (estimated)
Last update
Oct 15, 2024

Study contacts

Adina Prof. Maeir, PhD
Contact
adina.maeir@mail.hui.ac.il
972 546205081
Ruthi Dr Traub Bar Ilan, PhD
Contact
ruthie.traub@mail.huji.ac.il.il
972 544990500

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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