Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adult ADHD
• Intervention / Treatment: Other: Recollect, the game; Other: Tetris

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Patterson, MSc; Phone Number: 289-396-4242; Email: bpatter@mcmaster.ca
• Study Contact Backup: Name: Jasmine Turna, PhD(c); Phone Number: 289-396-4242; Email: turnaj@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1B7
      • MacAnxiety Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females aged 18 and older who own a mobile device such as a Smartphone or tablet.
2. Current diagnosis of Adult ADHD, at any stage of treatment.
3. Comorbid psychiatric conditions will be allowed.
4. Medication or psychotherapy must have been stable (no dose changes) for 4 weeks prior to study participation.
5. Must be able to read, write and understand English.

Exclusion Criteria:

1. Participant does not own a Smartphone or tablet.
2. No dose changes during the 4 week study period.
3. No initiation of new psychological therapy or counselling during the 4 week study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recollect; 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.	Other: Recollect, the game; "Recollect" is a working memory training game
Sham Comparator: Tetris; Tetris is a video game which has not been shown to have any benefits in the improvement of executive functioning.	Other: Tetris; App-based video game where shapes are rotated and placed to fit a grid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	Change from baseline to week 4

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Michael Van Ameringen, MD, FRCPC, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ADHD; game; executive functioning
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Recollect_ADHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No