Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
Primary Purpose
Adult ADHD
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Recollect, the game
Tetris
Sponsored by
About this trial
This is an interventional treatment trial for Adult ADHD focused on measuring ADHD, executive functioning, game
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- MacAnxiety Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Recollect
Tetris
Arm Description
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.
Tetris is a video game which has not been shown to have any benefits in the improvement of executive functioning.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03437993
Brief Title
Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
Official Title
Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult ADHD
Keywords
ADHD, executive functioning, game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recollect
Arm Type
Experimental
Arm Description
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.
Arm Title
Tetris
Arm Type
Sham Comparator
Arm Description
Tetris is a video game which has not been shown to have any benefits in the improvement of executive functioning.
Intervention Type
Other
Intervention Name(s)
Recollect, the game
Intervention Description
"Recollect" is a working memory training game
Intervention Type
Other
Intervention Name(s)
Tetris
Intervention Description
App-based video game where shapes are rotated and placed to fit a grid
Primary Outcome Measure Information:
Title
Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
Description
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.
Time Frame
Change from baseline to week 4
Secondary Outcome Measure Information:
Title
Change from baseline on the Barkley Adult ADHD Rating Scale (BAARS-IV)
Description
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.
Time Frame
Change from baseline to week 4
Title
Change from baseline on an App-based neuro-cognitive battery
Description
A number of neuro-cognitive executive functioning tests, which will be administered via a smartphone application
Time Frame
Change from baseline to week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Patterson, MSc
Phone
289-396-4242
Email
bpatter@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine Turna, PhD(c)
Phone
289-396-4242
Email
turnaj@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Van Ameringen, MD, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Patterson, MSc
Phone
289-396-4242
Email
bpatter@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Jasmine Turna, PhD (c)
Phone
289-396-4242
Email
turnaj@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Michael Van Ameringen, MD, FRCPC
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD
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