Clinical trial NCT04571320: A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Official title: A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Keywords: ADHD
School-based
Peer-delivered
Adolescence
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institute of Mental Health (NIMH)
First posted: 2020-10-01
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test whether a peer-delivered intervention for high school students with ADHD outperforms enhanced school services as usual. Ninth grade students with ADHD (N=72) will be randomly assigned to the intervention (summer STRIPES) or the enhanced school services control group (SSU plus). Students will be assessed in the spring of 8th grade, fall of ninth grade, and spring of ninth grade. Primary outcomes will be GPA, Class Attendance, Disciplinary Incidents, and ADHD symptoms (parent and teacher report).

Detailed description: The proposed study will adapt and test a low resource school-based intervention to prepare students with ADHD for the transition to high school-a point of vulnerability for youth with ADHD. The resulting intervention will be delivered as a peer-delivered orientation to high school (1-2 weeks for 4 hours a day) with weekly peer-delivered support during the first 16 weeks of the ninth grade year. Intervention development will involve scaling down an intensive Summer Treatment Program for adolescents with ADHD, using its core components (i.e., daily skills training and repetition, parent coaching in contingency management, engaging recreational activities) to bolster a promising peer-delivered school-based intervention for ninth graders with ADHD. The resulting intervention (summer STRIPES) will target three mechanisms that are critical markers of high school success: (a) intrinsic motivation, (b) extrinsic motivation, and (c) executive functions (EFs). Y01, will use a stakeholder informed process to iteratively adapt the intervention with input from two partnering high schools (i.e., administrators, counselors, teachers, parents, students) and content experts (Sibley, Langberg, Sasser, Aaronson). Two manuals that are individualized for each school will emerge. A total of 72 rising ninth grade students with ADHD will be recruited in Y02 and Y03 (36 per year; 18 per school) from two high schools randomly assigned (within school) to receive summer STRIPES or enhanced school services as usual (SSU plus). A school staff summer STRIPES sponsor at each school will oversee training and supervision peer interventionists with support from investigators. Peer interventionists will receive a three-day training and weekly supervision. Study assessments will occur at baseline and three follow-up points throughout the ninth grade year. To test the intervention's preliminary effectiveness, the study will examine treatment effects on GPA, class attendance, and disciplinary incidents. Preliminary effectiveness will also be measured through indices of engagement (parent, adolescent, peer attendance, ratings of satisfaction, perceived utility, and therapeutic alliance) and school fit (treatment fidelity, peer attitudes toward treatment). To detect whether therapeutic mechanisms (intrinsic motivation, extrinsic motivation, EFs) are engaged by summer STRIPES, the investigators will test for group differences on multi-method indices of these mechanisms, as well as the extent to which hypothesized mechanisms affect meaningful change on study outcomes. This project represents the first attempt to utilize a peer-delivered model for ADHD intervention in a high school orientation context. If summer STRIPES participants show meaningful improvements in functioning and engagement and school fit are strong, an R01 will be planned to fully evaluate the effectiveness of this approach. To inform this future trial, attention will be given to developing an optimal measurement battery, treatment delivery model, and recruitment strategy for rising ninth graders.

Eligibility criteria: Inclusion Criteria:

* Meet Symptom and Impairment Criteria for DSM-5 ADHD
* Attending ninth grade at a participating school

Exclusion Criteria:

* Placement in special education classes
* IQ \< 70

Primary outcomes:
measure: Grade Point Average
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Class Attendance
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Attention Deficit Hyperactivity Disorder Symptom Severity
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: Target Mechanism: Extrinsic Motivation (measure 1)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Extrinsic Motivation (measure 2)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Extrinsic Motivation (measure 3)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Extrinsic Motivation (measure 4)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Intrinsic Motivation (measure 1)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Intrinsic Motivation (measure 2)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Intrinsic Motivation (measure 3)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Intrinsic Motivation (measure 4)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 1)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 2)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 3)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 4)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 5)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 6)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 7)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 8)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Target Mechanism: Executive Functions (measure 9)
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Engagement and Fit Measures: Fidelity Checklists
timeFrame: During Intervention Delivery, an average of 1 year
measure: Engagement and Fit Measures: Intervention Attendance
timeFrame: During Intervention Delivery, an average of 1 year
measure: Engagement and Fit Measures: Parent Academic Involvement
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
measure: Engagement and Fit Measures: Intervention Credibility
timeFrame: Immediately post-treatment
measure: Engagement and Fit Measures: Intervention Credibility
timeFrame: Immediately post-treatment
measure: Engagement and Fit Measures: Satisfaction
timeFrame: Immediately post-treatment
measure: Engagement and Fit Measures: Therapy-Bond and Engagement Scales
timeFrame: Immediately post-treatment
measure: Follow-up Focus Groups and Surveys
timeFrame: Immediately post-treatment
measure: Follow-up Focus Groups and Surveys
timeFrame: Immediately post-treatment
measure: Follow-up Focus Groups and Surveys
timeFrame: Immediately post-treatment
measure: Time Varying Covariate: Medication Use
timeFrame: Change from Baseline to End of 9th grade, an average of 1 year
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Margarret Sibley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zulauf-McCurdy CA, Coxe SJ, Lyon AR, Aaronson B, Ortiz M, Sibley MH. Study protocol of a randomised trial of Summer STRIPES: a peer-delivered high school preparatory intervention for students with ADHD. BMJ Open. 2021 Aug 3;11(8):e045443. doi: 10.1136/bmjopen-2020-045443.