Recruiting

Game-supported Intervention

Sponsor:

East Carolina University

Code:

NCT05048043

Conditions

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

Interventions

Computer-assisted Behavior Intervention

Challenging Horizons Program

Study Details

Brief summary:

The investigators will develop and pilot test an innovative computer-assisted behavior intervention (CABI) for middle school students with attention-deficit/hyperactivity disorder (ADHD). The CABI will deliver evidence-based behavior interventions for ADHD in a manner that is acceptable to teachers and motivating for students. The key element of the CABI is a serious game that will teach and encourage rehearsal of ADHD coping skills in an engaging game environment. Transfer of those skills to authentic education settings will be facilitated by teacher interventionists in consultation with school or clinical psychologists. The investigators will test the CABI condition (n = 18) against traditional teacher consultation for ADHD (n = 18) on measures of consultation fidelity and student academic and behavioral outcomes.

Conditions

Attention Deficit Hyperactivity Disorder

Study ID

NCT05048043

Start date

Sep 27, 2021

Status verified date

Sep, 2021

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All participants must meet DSM-5 criteria for ADHD (any presentation);
  • A history of academic impairment (regardless of medication status)

Exclusion Criteria:

  • Estimated full-scale IQ less than 80;
  • Plans to leave the school district during the study timeframe;
  • Psychiatric conditions ill-suited to the proposed intervention (e.g., psychosis, bipolar disorder)

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Computer-assisted Behavior Intervention

A serious game paired with teacher consultation to address common needs related to ADHD in the classroom.

active comparator: Challenging Horizons Program, School Consultation

An established teacher consultation program to help teachers address ADHD in the classroom.

Interventions

Computer-assisted Behavior Intervention

The CABI includes a serious game called "ATHEMOS" that is designed to help students rehearse skills that ameliorate impairments associated with ADHD, including organization, scheduling, and note taking strategies. Once students have some experience with the game, a teacher consultee will help students actively transfer skills learned in the game to real-world classroom demands.

Challenging Horizons Program

The Challenging Horizons Program is an established psychosocial intervention package for young adolescents with ADHD, focusing on academic and behavioral impairments.

Primary outcome measure

  • Change from baseline on the Classroom Performance Survey (CPS) [ Time Frame: Baseline and 16 weeks ]
  • Change from baseline on the School Functioning Scale (SFS) [ Time Frame: Baseline and 16 weeks ]
  • Change from baseline on the Children's Organizational Skills Scale--Parent Report (COSS-P) [ Time Frame: Baseline and 16 weeks ]

Central Contacts and Locations

Central contacts

Office of Research Integrity and Compliance

2527442914oric@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Brandon K Schultz, Ed.D.

252-737-4956schultzb@ecu.edu

Christina Suggs, BA

2523286876suggsc@ecu.edu

Ohio University

Recruiting

Athens, Ohio, United States, 45701

Contacts

Steven W Evans, Ph.D.

740-593-2186evanss3@ohio.edu

More Information

Sponsor

East Carolina University

Last update posted

Feb 17, 2022

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2022-02-17.