Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05048043
Status:
UNKNOWN
Last Update Posted:
2022-02-17
First Post:
2021-08-02
Brief Title:
Development of a Game-supported Intervention
Sponsor:
East Carolina University
Organization:
East Carolina University
Study Overview
Official Title:
Development of a Game-supported Intervention to Improve Learning and Study Strategies Among At-Risk Students
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will develop and pilot test an innovative computer-assisted behavior intervention CABI for middle school students with attention-deficithyperactivity 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 95 of school-age children in the United States have attention deficit hyperactivity disorder ADHD affecting 25 to 48 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 eg 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 SAMHSAs 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
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 SAMHSAs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R324A180219 | OTHER_GRANT | Department of Education | None |