NCT03437993

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

5.8 years

First QC Date

February 7, 2018

Last Update Submit

October 24, 2023

Conditions

Keywords

ADHDexecutive functioninggame

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline on the Barkley Adult ADHD Rating Scale (BAARS-IV)

    Change from baseline to week 4

  • Change from baseline on an App-based neuro-cognitive battery

    Change from baseline to week 4

Study Arms (2)

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.

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.

Other: Tetris

Interventions

"Recollect" is a working memory training game

Recollect
TetrisOTHER

App-based video game where shapes are rotated and placed to fit a grid

Tetris

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael Van Ameringen, MD, FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 19, 2018

Study Start

March 14, 2019

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations