Adult ADHDNCT03437993
Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
A study testing Recollect, the game and Tetris in people with Adult ADHD, run by McMaster University at 1 site in Canada.
Trial summary
Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant occupational, academic and social problems, many of which are believed to be a result of problems with executive functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult ADHD
- What is being tested?
- Recollect, the game and Tetris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2019to 28 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 and older who own a mobile device such as a Smartphone or tablet.
- Current diagnosis of Adult ADHD, at any stage of treatment.
- Comorbid psychiatric conditions will be allowed.
- Medication or psychotherapy must have been stable (no dose changes) for 4 weeks prior to study participation.
- Must be able to read, write and understand English.
Who cannot join
- Participant does not own a Smartphone or tablet.
- No dose changes during the 4 week study period.
- No initiation of new psychological therapy or counselling during the 4 week study period.
Trial locations and contacts
1 site in 1 country.
About this study
Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant occupational, academic and social problems, many of which are believed to be a result of problems with executive functioning. Executive functioning refers to a group of neuro-psychological functions which include sustained attention, working memory, verbal fluency, as well as motor and mental processing speed. Individuals with ADHD have been shown to have deficits in executive functioning independent of IQ, co-occurring psychiatric disorders, gender, and ADHD subtype. "Recollect" is an application (App) based working memory training video game where participants conduct 3-different adaptive working memory tasks. In each of these tasks participants are presented with a set of stimuli to be remembered while playing a simple platform game where they help navigate an astronaut across the screen and dodge obstacles. Recollect has been designed for all age groups to an interesting, fun and effective brain-training activity. The memory tasks included in the game have been independently shown to improve working memory in a manner that transfers to untrained tasks.
The purpose of this study is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult ADHD.
Read the detailed description
The primary objective is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult Attention Deficit Hyperactivity Disorder (ADHD).Consenting participants will be screened using the Mini International Neuropsychiatric Interview for DSM-5 (MINI) to confirm ADHD diagnosis. Participants will be asked to download either Recollect or Tetris on their own mobile device. Following a training/orientation session, they will be asked to spend 20 minutes per day at least 5 days per week playing Recollect or Tetris over a 4 week period. At Week 4, study staff will check the time log on the Recollect/Tetris App to confirm how much time was spent playing the game. Participants will be asked to complete two ADHD symptom severity scales, as well as App-based neurocognitive testing at baseline (Week 0) and endpoint (Week 4).
- Conditions
- Adult ADHD
- Being tested
- Recollect, the game, Tetris
- Keywords
- ADHD, executive functioning, game
- 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.
Recollect, the gameOther
"Recollect" is a working memory training game
TetrisOther
App-based video game where shapes are rotated and placed to fit a grid
| Study group | Role | What they receive |
|---|---|---|
| Recollect | Experimental | Recollect is a video game which incorporates scientifically supported renditions of N-Back, Item Span, and Multiple-Identity tracking tasks. These tasks are independently shown to improve working memory in a manner that transfers to untrained tasks. Receives: Other: Recollect, the game |
| Tetris | Sham comparator | Tetris is a video game which has not been shown to have any benefits in the improvement of executive functioning. Receives: Other: Tetris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
It is a validated, clinician-rated scale, measuring executive functioning. The scale includes 75 items that rates patient symptoms on a 3-point Likert scale (1 = behavior is never observed to 3 = behavior is often observed). Scores range from 75 to 225: Higher scores indicate greater impairment in executive functioning.
Measured: Change from baseline to week 4
Secondary outcomes (2)
Change from baseline on the Barkley Adult ADHD Rating Scale (BAARS-IV)
Self-report scale evaluating ADHD symptoms. Symptom count scores range from 1 to 27, with higher scores indicating more ADHD symptoms. Total scores range from 27 to 108, with higher scores indicating greater severity of symptoms.
Measured: Change from baseline to week 4
Change from baseline on an App-based neuro-cognitive battery
A number of neuro-cognitive executive functioning tests, which will be administered via a smartphone application
Measured: Change from baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start14 Mar 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ADHDStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437993
- Sponsor's protocol ID
- Recollect_ADHD
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2018
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
- ClinicalTrials.gov ID
- NCT03437993
- Acronym / sponsor ID
- Recollect_ADHD
- Conditions
- Adult ADHD
- Keywords
- ADHD, executive functioning, game
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Feb 2018 (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.
Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant occupational, academic and social problems, many of which are believed to be a result of problems with executive functioning. Executive functioning refers to a group of neuro-psychological functions which include sustained attention, working memory, verbal fluency, as well as motor and mental processing speed. Individuals with ADHD have been shown to have deficits in executive functioning independent of IQ, co-occurring psychiatric disorders, gender, and ADHD subtype. "Recollect" is an application (App) based working memory training video game where participants conduct 3-different adaptive working memory tasks. In each of these tasks participants are presented with a set of stimuli to be remembered while playing a simple platform game where they help navigate an astronaut across the screen and dodge obstacles. Recollect has been designed for all age groups to an interesting, fun and effective brain-training activity. The memory tasks included in the game have been independently shown to improve working memory in a manner that transfers to untrained tasks.
The purpose of this study is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult ADHD.
Detailed description
The primary objective is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult Attention Deficit Hyperactivity Disorder (ADHD).Consenting participants will be screened using the Mini International Neuropsychiatric Interview for DSM-5 (MINI) to confirm ADHD diagnosis. Participants will be asked to download either Recollect or Tetris on their own mobile device. Following a training/orientation session, they will be asked to spend 20 minutes per day at least 5 days per week playing Recollect or Tetris over a 4 week period. At Week 4, study staff will check the time log on the Recollect/Tetris App to confirm how much time was spent playing the game. Participants will be asked to complete two ADHD symptom severity scales, as well as App-based neurocognitive testing at baseline (Week 0) and endpoint (Week 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recollect | Experimental | Other: Recollect, the gameRecollect is a video game which incorporates scientifically supported renditions of N-Back, Item Span, and Multiple-Identity tracking tasks. These tasks are independently shown to improve working memory in a manner that transfers to untrained tasks. |
| Tetris | Sham comparator | Other: TetrisTetris is a video game which has not been shown to have any benefits in the improvement of executive functioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged 18 and older who own a mobile device such as a Smartphone or tablet.
- Current diagnosis of Adult ADHD, at any stage of treatment.
- Comorbid psychiatric conditions will be allowed.
- Medication or psychotherapy must have been stable (no dose changes) for 4 weeks prior to study participation.
- Must be able to read, write and understand English.
Key exclusion criteria (3 listed)
- Participant does not own a Smartphone or tablet.
- No dose changes during the 4 week study period.
- No initiation of new psychological therapy or counselling during the 4 week study period.
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 |
|---|---|---|
| Recollect, the game"Recollect" is a working memory training game | Other | Recollect |
| TetrisApp-based video game where shapes are rotated and placed to fit a grid | Other | Tetris |
Primary outcome
Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
Time frame: Change from baseline to week 4
It is a validated, clinician-rated scale, measuring executive functioning. The scale includes 75 items that rates patient symptoms on a 3-point Likert scale (1 = behavior is never observed to 3 = behavior is often observed). Scores range from 75 to 225: Higher scores indicate greater impairment in executive functioning.
2 secondary outcomes
Change from baseline on the Barkley Adult ADHD Rating Scale (BAARS-IV)
Time frame: Change from baseline to week 4
Change from baseline on an App-based neuro-cognitive battery
Time frame: Change from baseline to week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- 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.
Michael Van Ameringen, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recollect, the game and Tetris in people with Adult ADHD, run by McMaster University at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
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?
Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A) (time frame: Change from baseline to week 4). 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 26 Oct 2023.