Clinical trial NCT05048043: Development of a Game-supported Intervention
Official title: Development of a Game-supported Intervention to Improve Learning and Study Strategies Among At-Risk Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Ohio University
First posted: 2021-09-17
Enrollment: 36
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline on the Classroom Performance Survey (CPS)
timeFrame: Baseline and 16 weeks
measure: Change from baseline on the School Functioning Scale (SFS)
timeFrame: Baseline and 16 weeks
measure: Change from baseline on the Children's Organizational Skills Scale--Parent Report (COSS-P)
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change from baseline on the Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: Baseline and 16 weeks
measure: Group comparison of School Grades
timeFrame: Up to 6 months
measure: Group comparison of Satisfaction Questionnaire data
timeFrame: Up to 6 months
measure: Descriptive single-group analysis of Technology Acceptance Model Instrument - Fast Form
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: East Carolina University
name: Brandon Schultz, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.