Attention Deficit Hyperactivity DisorderNCT02681575
Meta-cognitive Functional Intervention for Adults With ADHD: A Pilot Efficacy Study
A study testing Cog-Fun - A in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Cog-Fun - A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ADHD diagnosed by certified medical practitioner
- Adult ADHD Self Report Scale (ASRS) score above cutoff
- BRIEF-A score above cutoff
Who cannot join
- Diagnoses of severe neurological or psychiatric health condition.
- Instability in pharmacological treatment
- Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meta-cognitive Functional Intervention for Adults (Cog-Fun - A) With Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Efficacy Study
The purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD).
It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate improvements in measures of executive functioning, occupational performance and quality of life.
Read the detailed description
The Cog-Fun - A is a structured occupational therapy intervention for promoting self management in adults with ADHD. The protocol comprises three central treatment modules: Adaptive self awareness, executive strategies and skill implementation and multi-context transfer of strategies and skills.
The intervention is administered by occupational therapists on an individual basis, once a week, over 3-4 months.
20 participants will be recruited through community advertising. Sample size was determined based on expected moderate effect sizes. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.
Adverse events if occur will be reported to supervising psychiatrist and the Helsinki Committee.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Cog-Fun - A
- 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.
Cog-Fun - ABehavioural
Meta-cognitive functional intervention for improved self management in adults with ADHD
| Study group | Role | What they receive |
|---|---|---|
| Cog-Fun A | Experimental | Metacognitive-Functional occupational therapy intervention (Cog-Fun - A) includes enhancing self awareness in occupational context, acquiring executive strategies and skills and implementation across multiple occupational domains. Receives: Behavioral: Cog-Fun - A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)
Self rating questionnaire targeting executive functions in daily life
Measured: 3-4 months
Secondary outcomes (2)
Adult ADHD Quality of Life Scale (AaQoL)
Self rating questionnaire targeting the impact of ADHD on Life Productivity, Psychological Health, Relationships and Life outlook
Measured: 3-4 months
Canadian Occupational Performance Measure
structured interview administered by occupational therapist
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Bonne, MD, Principal investigator, HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681575
- Sponsor's protocol ID
- 0658-15-HMO
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meta-cognitive Functional Intervention for Adults (Cog-Fun - A) With Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Efficacy Study
- ClinicalTrials.gov ID
- NCT02681575
- Acronym / sponsor ID
- 0658-15-HMO
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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 purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD).
It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate improvements in measures of executive functioning, occupational performance and quality of life.
Detailed description
The Cog-Fun - A is a structured occupational therapy intervention for promoting self management in adults with ADHD. The protocol comprises three central treatment modules: Adaptive self awareness, executive strategies and skill implementation and multi-context transfer of strategies and skills.
The intervention is administered by occupational therapists on an individual basis, once a week, over 3-4 months.
20 participants will be recruited through community advertising. Sample size was determined based on expected moderate effect sizes. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.
Adverse events if occur will be reported to supervising psychiatrist and the Helsinki Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cog-Fun A | Experimental | Behavioral: Cog-Fun - AMetacognitive-Functional occupational therapy intervention (Cog-Fun - A) includes enhancing self awareness in occupational context, acquiring executive strategies and skills and implementation across multiple occupational domains. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ADHD diagnosed by certified medical practitioner
- Adult ADHD Self Report Scale (ASRS) score above cutoff
- BRIEF-A score above cutoff
Key exclusion criteria (3 listed)
- Diagnoses of severe neurological or psychiatric health condition.
- Instability in pharmacological treatment
- Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms
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 |
|---|---|---|
| Cog-Fun - AMeta-cognitive functional intervention for improved self management in adults with ADHD | Behavioural | Cog-Fun A |
Primary outcome
Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)
Time frame: 3-4 months
Self rating questionnaire targeting executive functions in daily life
2 secondary outcomes
Adult ADHD Quality of Life Scale (AaQoL)
Time frame: 3-4 months
Canadian Occupational Performance Measure
Time frame: 3-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Omer Bonne, MD principal investigator
HMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cog-Fun - A in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Ratings of Executive Functions - Adult version (BRIEF-A) (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.