Development of a Game-supported Intervention

NCT05048043 | Unknown

• 2 other identifiers: 18-001555R324A180219
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Change from baseline on the Classroom Performance Survey (CPS)

  The Classroom Performance Survey (CPS) is a 15-item instrument that assesses the unique performance demands of secondary schools using 5-point Likert-type response formats. Research shows that the CPS is comprised of two subscales-referred to as academic competence (10 items; range = 10 - 50; M = 23.7; SD = 10.8) and interpersonal competence (5 items; range = 5 - 25; M = 9.5; SD = 4.8)-with high internal reliability (α = .98 and .91, respectively). Criterion-related validity with the Impairment Rating Scale, an established measure of functional impairment, concluded that the CPS was significantly and meaningfully related to that criterion (rs = .47 to .73) (Brady et al., 2012). Higher scores suggest greater degrees of academic impairment.

  Baseline and 16 weeks

• Change from baseline on the School Functioning Scale (SFS)

  The School Functioning Scale (SFS) is a 10-item instrument that assesses school-related impairments in secondary schools using 5- or 6-point Likert type response formats (range = 9 to 47). Psychometric properties suggest that the SFS is a valid and reliable measure of school performance, with a single overall score (general factor; M = 38.2; SD = 7.0) accounting for the largest percent of variance, strongest reliability, and highest factor loading when compared to 2- and 3-factor models. Proposed subscales include a 5-item academic (M = 16.5; SD = 3.2), 3-item behavior (M = 6.2; SD = 3.1), and 2-item social factors (M = 9.9; SD = 2.2) (DuPaul et al., 2019). Higher scores represent more effective school functioning.

  Baseline and 16 weeks

• Change from baseline on the Children's Organizational Skills Scale--Parent Report (COSS-P)

  The Children's Organizational Skills Scale--Parent Report (COSS-P) is a 66-item instrument that assesses children's organization, time management, and planning using 4-point Likert-type response formats. The COSS-P is comprised of psychometrically validated subscales, including Task Planning (6-items; range = 6 to 24), Organized Actions (10-items; range = 10 to 40), and Memory and Materials Management (10 items; range = 10 to 40). High scores on these subscales suggest greater levels of organization. In addition, an impairment scale is computed from 8 items (range = 8 to 32), where high scores suggest greater levels of impairment. An overall total score is derived from the 56 non-impairment items (range = 56 to 224), where high scores suggest greater levels of organization. The COSS-P was normed with a representative sample of parents, allowing a conversion from raw scores to T-scores (Molitor et al., 2017).

  Baseline and 16 weeks

Secondary Outcomes (4)

• Change from baseline on the Working Alliance Inventory - Short Revised (WAI-SR)

  Baseline and 16 weeks

• Group comparison of School Grades

  Up to 6 months

• Group comparison of Satisfaction Questionnaire data

  Up to 6 months

• Descriptive single-group analysis of Technology Acceptance Model Instrument - Fast Form

  16 weeks

Study Arms (2)

Computer-assisted Behavior Intervention

EXPERIMENTAL

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

Behavioral: Computer-assisted Behavior Intervention

Challenging Horizons Program, School Consultation

ACTIVE COMPARATOR

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

Behavioral: Challenging Horizons Program

Interventions

Computer-assisted Behavior Intervention 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.

Also known as: ATHEMOS

Computer-assisted Behavior Intervention

Challenging Horizons Program BEHAVIORAL

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

Also known as: CHP

Challenging Horizons Program, School Consultation

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• East Carolina University: lead
• Ohio University: collaborator

Study Sites (2)

East Carolina University

Greenville, North Carolina, 27858, United States

RECRUITING

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 20013760 BACKGROUND

• 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.

  PMID: 31045408 BACKGROUND

• 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.

  PMID: 28983327 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Brandon Schultz, Ed.D.

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Office of Research Integrity and Compliance

CONTACT

2527442914; oric@ecu.edu

Study Design

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

Model Details: Eligible families will be randomly assigned to either the CABI or traditional consultation condition. The investigators will use a two-wave cohort design, so that one-half of the sample will be randomly assigned to participate in the first semester (September to December) and the second half in the second semester (January to May), assuring that the proportion of students in each condition do not exceed a 5:4 ratio each semester. Participation will end with a post-intervention evaluation in December or May (depending on wave), thereby providing three total measurement occasions.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: September 17, 2021
• Study Start: September 27, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 17, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)