Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Development of a Game-supported Intervention to Improve Learning and Study Strategies Among At-Risk Students
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 14 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Ohio University | Athens | Ohio |
United States | East Carolina University | Greenville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
East Carolina University | Ohio University |
United States,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (a = .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 | |
Primary | 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 | |
Primary | 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 | Change from baseline on the Working Alliance Inventory - Short Revised (WAI-SR) | The Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item self-report measure of working alliance between therapists and client that will be modified for the present study to measure the relationship between students and their teacher mentors. The WAI-SR uses a 5-point Likert-type response format, producing a total score ranging from 12 to 60. The instrument has demonstrated adequate psychometric properties (e.g., Munder et al., 2010). The investigators will modify the language slightly for the purposes of the present study (e.g., changing "therapist" to "teacher mentor"). Higher scores represent better working alliance. | Baseline and 16 weeks | |
Secondary | Group comparison of School Grades | Report card data from the participants, as provided by the participating schools. Grades are scaled on a 5-point scale, from A (4.0) to F (0.0). Any variation in that format will be rescaled to make the scores comparable across sites. | Up to 6 months | |
Secondary | Group comparison of Satisfaction Questionnaire data | An 8-item satisfaction questionnaire used in previous studies of the Challenging Horizons Program administered to teachers, parents, and students. Each item uses a 4-point Likert-type response format, and total scores range from 8 to 32. Higher scores represent higher program satisfaction. Although the instrument has not been examined psychometrically, the feedback will be used to identify elements of the program that participants valued. | Up to 6 months | |
Secondary | Descriptive single-group analysis of Technology Acceptance Model Instrument - Fast Form | A satisfaction questionnaire to assess the acceptability of a new technology, adapted to inquire specifically about the computer-assisted behavior intervention. Will be administered to teachers who participate in the experimental arm of the present study. The Technology Acceptance Model Instrument-Fast Form is comprised of 12-items, and each item uses a 7-point Likert-type response format ranging from -3 to +3. Total scores range from -36 to +36. Higher scores represent higher levels of instrument acceptability. | 16 weeks |
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