ADHDADHDNCT06639139
The Effectiveness of Cognitive-Functional Remote Group Intervention (Cog-Fun RG) for Adults with Attention Deficit Hyperactivity Disorder (ADHD)
A study testing CogFun RG occupational therapy in people with ADHD, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ADHD
- What is being tested?
- CogFun RG occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Self Reported ADHD diagnoses
Who cannot join
- Self Reported other major health condition that impedes daily functioning
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hebrew University
Jerusalem
Adina Maeir, PhD, 0546205081, adina.maeir@mail.huji.ac.il
Ruthie Traub Bar Ilan, PhD, 972 544995000, ruthie.traub@mail.huji.ac.il
About this study
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.
Read more
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.
- Conditions
- ADHD
- Being tested
- CogFun RG occupational therapy
- Keywords
- Occupational Therapy, Executive Functions, Remote Group Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogFun RG occupational therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline, immediately after the intervention, immediately after the waiting period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adina Maeir, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639139
- Sponsor's protocol ID
- 10032020
- Acronym
- ADHD
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: currently we do not have such a plan we will be happy to consider this in the future
Publications
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.
PubMed 40337196Kastner 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cognitive-Functional Remote Group Intervention (Cog-Fun RG) for Adults with Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06639139
- Acronym / sponsor ID
- ADHD / 10032020
- Conditions
- ADHD
- Keywords
- Occupational Therapy, Executive Functions, Remote Group Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CogFun RG occupational therapy | Experimental | Behavioral: CogFun RG occupational therapyOccupational 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. |
| Waitlist Control Group | No intervention | –Waiting list, no intervention. After waitlist period will receive the same intervention as the first arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self Reported ADHD diagnoses
Key exclusion criteria (1 listed)
- Self Reported other major health condition that impedes daily functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CogFun RG occupational therapy21 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 | Behavioural | CogFun RG occupational therapy |
Primary outcome
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.
1 secondary outcome
Behavioral Rating Inventory of Executive Functions (BRIEF) Adult Self -Report
Time frame: at baseline, immediately after the intervention, immediately after the waiting period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 40337196Galili-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.
- Background: PubMed 35258515Kastner 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.
- Individual participant dataSharing planned: No. currently we do not have such a plan we will be happy to consider this in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CogFun RG occupational therapy in people with ADHD, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adina Prof. Maeir, PhD (972 546205081, adina.maeir@mail.hui.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639139, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.