Development of a Game-supported Intervention

NCT ID: NCT05048043

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2022-06-30

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.

Detailed Description

An estimated 5% to 9.5% of school-age children in the United States have attention deficit hyperactivity disorder (ADHD), affecting 2.5 to 4.8 million public school students. ADHD is a costly disorder that often goes untreated, especially among adolescents. School-based behavior interventions can be efficacious, but there are persistent implementation challenges in those settings, resulting in a research-practice gap. Computer-based programs have emerged to potentially strengthen school-based intervention, but most target the neuropsychological correlates of ADHD (e.g., working memory deficits) rather than its impairments, with disappointing results. Designers have assumed that gains in neuropsychological functioning can indirectly alleviate ADHD impairments in real-world settings; the research, however, does not support this assumption. As an alternative, serious games might teach coping skills that directly remediate ADHD impairments, and then those new skills might be transferred to a target setting with the active assistance of interventionists. To date, game designers have not explored the latter approach.

This study will be the first to test an effort to actively transfer ADHD coping skills learned in a serious game to an authentic education setting. The game, called ATHEMOS, is based on the Challenging Horizons Program, which was inducted into SAMHSA's National Registry of Evidence-based Programs and Practices in 2010. The broad research aims are to (a) develop the serious game (ATHEMOS) that will teach evidence-based ADHD coping skills to adolescents; (b) test and revise initial versions of the game using feedback from focus groups and feasibility case studies; and (c) determine the degree to which these innovations achieve the benefits predicted. The last aim is the focus of this clinical trial registration, and will be achieved in a pilot study whereby middle school students with ADHD will be randomly assigned to receive the computer-assisted behavior intervention (CABI) or traditional school consultation for ADHD. The pilot study will occur at two sites (North Carolina and Ohio), with each site recruiting 18 participants. The investigators will verify ADHD diagnosis in an intake evaluation, randomly assign to conditions, and then begin school consultation with an identified teacher "mentor" for each case in the participating schools. After up to 16-weeks of intervention, the investigators will conduct an end-of-intervention evaluation. The data will be analyzed in a regression framework. Outcome measures at post-test will be regressed on pretest scores and a dummy variable representing condition. The slope of this dummy variable represents how change from pre to post-test differs across conditions. This approach provides a more powerful test of group differences in change than simple difference scores or analysis of variance. If after random assignment, one condition differs significantly from the other on an intake measure, the investigators may use that indicator as a covariate to adjust for this difference in subsequent analyses. The investigators will also assess clinical significance for all symptom and impairment measures to preliminarily compare the results to the relevant treatment literature.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer-assisted Behavior Intervention

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

Group Type: EXPERIMENTAL

Computer-assisted Behavior Intervention

Intervention Type: BEHAVIORAL

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, School Consultation

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

Group Type: ACTIVE_COMPARATOR

Challenging Horizons Program

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

Challenging Horizons Program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

ATHEMOS; CHP

Eligibility Criteria

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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio University

OTHER

Sponsor Role: collaborator

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandon Schultz, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

East Carolina University

Greenville, North Carolina, United States

Site Status: RECRUITING

Ohio University

Athens, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Office of Research Integrity and Compliance

Role: CONTACT

oric@ecu.edu

2527442914

Facility Contacts

Brandon K Schultz, Ed.D.

Role: primary

schultzb@ecu.edu

252-737-4956

Christina Suggs, BA

Role: backup

suggsc@ecu.edu

2523286876

Steven W Evans, Ph.D.

Role: primary

evanss3@ohio.edu

740-593-2186

References

Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.

Reference Type: BACKGROUND

PMID: 20013760 (View on PubMed)

DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.

Reference Type: BACKGROUND

PMID: 31045408 (View on PubMed)

Molitor SJ, Langberg JM, Evans SW, Dvorsky MR, Bourchtein E, Eddy LD, Smith ZR, Oddo LE. Evaluating the Factor Validity of the Children's Organizational Skills Scale in Youth with ADHD. School Ment Health. 2017 Jun;9(2):143-156. doi: 10.1007/s12310-016-9205-0. Epub 2016 Dec 27.

Reference Type: BACKGROUND

PMID: 28983327 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R324A180219

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18-001555

Identifier Type: -

Identifier Source: org_study_id