Trial Outcomes & Findings for Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults (NCT NCT02127931)

Results Overview

Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

10 minutes

Results posted on

2020-01-14

Participant Flow

Participants were recruited from a highly selective college

Company no longer exists, and no longer has access to data collected. Only information from draft publication available.

Participant milestones

Participant milestones
Measure	All Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Overall Study Glitch in Game	1

Baseline Characteristics

Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=18 Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Age, Customized 18-25 years	18 Participants n=5 Participants
Sex/Gender, Customized NA	0 Participants n=5 Participants
Race/Ethnicity, Customized N/A	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes

Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist ADHD-C	2 Participants
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist ADHD- H/I	2 Participants
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist ADHD-I	5 Participants

PRIMARY outcome

Timeframe: 14 minutes

Continuous performance task (CPT), participants are asked to press the space bar when they are presented with any letter except the letter "X". The participant must refrain from clicking if they see the letter "X" presented.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Correlation of CPT Commission Errors With ADHD-I and ADHD-C ADHD-I	0.648 Correlation
Correlation of CPT Commission Errors With ADHD-I and ADHD-C ADHD-C	0.587 Correlation

PRIMARY outcome

Timeframe: 45 minutes

Groundskeeper is a game, there are four cubes and a base device, three of the cubes display a background of a grassy field, with occasional stimuli that pop up. The fourth cube displays a mallet. When a gopher is displayed on one of the cubes, the user must hit the gopher with the mallet. Groundskeeper incorrect counts of the number of incorrect responses when a target stimulus is presented. Continuous performance task (CPT), participants are asked to press the spacebar each time a letter appears in the middle of the screen, except when the letter is "X." If the letter is an "X", the participant should do nothing. Commission errors were when participant pressed the spacebar when an "X" appeared. Company no longer exists, and no longer has access to data collected. Only information from draft publication available.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Correlation of Groundskeeper Incorrect With CPT Commission Errors	0.587 Correlation

Adverse Events

College Students and Participants Requested to Complete CPT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Monika Roots, MD

CogCubed

Phone: 6122509737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place