Summer STRIPES: A Peer-Delivered High School Preparatory Intervention for Students With ADHD

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04571320
Collaborator
University of Washington (Other), National Institute of Mental Health (NIMH) (NIH)
72
1
2
25.9
2.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Summer STRIPES
  • Other: Enhanced School Services as Usual
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Teachers and outcomes assessors will be masked to group; however, it will not be possible to mask parents and adolescents to group because they will be actively receiving a behavioral intervention.
Primary Purpose:
Prevention
Official Title:
A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Summer STRIPES

Up to two weeks of daily high school orientation (four hours per day) immediately prior to the start of ninth grade, staffed by peer interventionists (2:1 ratio + extra interventionist in case of absences) and a school staff member. Two sessions of summer parent training. During the school year, ninth grade students will continue to meet weekly with their peer interventionists in a group setting under the supervision of the school staff sponsor. School year follow-up component of summer STRIPES will occur for 16 weeks and will include weekly 30 minute meetings between peer and target students. Parent components during the school year will include optional monthly group problem solving sessions with the school staff sponsor and school mental health liaison and a weekly phone call (up to five minutes) from the school staff sponsor to discuss home contingency management.

Behavioral: Summer STRIPES
See arm description.

Active Comparator: Enhanced School Services as Usual

Students who are assigned to the SSU plus group will be referred to their identified school counselor for referral to services available in the school setting. The counselor will be provided with a report from the student's intake assessment that summarizes the student's symptoms and presenting problems. The student will also receive new school supplies at the beginning of ninth grade. In our past trials, SSU plus students typically received subject-specific tutoring or after-school homework help. We will systematically track services received by students in the SSU plus condition.

Other: Enhanced School Services as Usual
see arm description.
Other Names:
  • SSU plus
  • Outcome Measures

    Primary Outcome Measures

    1. Grade Point Average [Change from Baseline to End of 9th grade, an average of 1 year]

      Quarterly Student Grade Point Average from Report Cards

    2. Class Attendance [Change from Baseline to End of 9th grade, an average of 1 year]

      Number of Class Absences per Academic Quarter

    3. Attention Deficit Hyperactivity Disorder Symptom Severity [Change from Baseline to End of 9th grade, an average of 1 year]

      Parent and Teacher Rated ADHD Symptoms on DSM-5 ADHD Checklist, 0=minimum, 3=maximum, Higher score means worse outcome

    Other Outcome Measures

    1. Target Mechanism: Extrinsic Motivation (measure 1) [Change from Baseline to End of 9th grade, an average of 1 year]

      Expectancy Value Theory of Motivation Measure (Student Report); Importance Subscale 1=minimum, 5=maximum, higher scores mean better outcome

    2. Target Mechanism: Extrinsic Motivation (measure 2) [Change from Baseline to End of 9th grade, an average of 1 year]

      Hungry Donkey Task (IOWA Gambling Task) --Risky Decision Making

    3. Target Mechanism: Extrinsic Motivation (measure 3) [Change from Baseline to End of 9th grade, an average of 1 year]

      Delay Discounting measured on Choice Delay task (total amount of money earned)

    4. Target Mechanism: Extrinsic Motivation (measure 4) [Change from Baseline to End of 9th grade, an average of 1 year]

      The Change Ruler self-report, 1=minimum value 10=maximum value, higher scores mean better outcome

    5. Target Mechanism: Intrinsic Motivation (measure 1) [Change from Baseline to End of 9th grade, an average of 1 year]

      Expectancy-Value Theory of Motivation Measure-Student Version, Interest subscale, 1=minimum, 5=maximum, higher scores mean better outcome

    6. Target Mechanism: Intrinsic Motivation (measure 2) [Change from Baseline to End of 9th grade, an average of 1 year]

      Delay Aversion; Quick Delay Questionnaire (self-report), 1=minimum value 5=maximum value, higher scores better outcomes, items 5-10 reverse coded

    7. Target Mechanism: Intrinsic Motivation (measure 3) [Change from Baseline to End of 9th grade, an average of 1 year]

      Change Ruler Scale self-report, 1=minimum value 10=maximum value, higher scores mean better outcome

    8. Target Mechanism: Intrinsic Motivation (measure 4) [Change from Baseline to End of 9th grade, an average of 1 year]

      Basic Psychological Needs Scale self-report, 1=minimum value 6=maximum value, higher scores mean better outcome

    9. Target Mechanism: Executive Functions (measure 1) [Change from Baseline to End of 9th grade, an average of 1 year]

      parent report: goal setting and planning section of the Self-Regulated Learning Interview Schedule

    10. Target Mechanism: Executive Functions (measure 2) [Change from Baseline to End of 9th grade, an average of 1 year]

      Behavior Rating Index of Executive Function (BRIEF-2) parent report

    11. Target Mechanism: Executive Functions (measure 3) [Change from Baseline to End of 9th grade, an average of 1 year]

      National Institute of Health (NIH) Toolbox List Sorting Working Memory Test

    12. Target Mechanism: Executive Functions (measure 4) [Change from Baseline to End of 9th grade, an average of 1 year]

      go/no-go task (number of commission errors on no-go trials)

    13. Target Mechanism: Executive Functions (measure 5) [Change from Baseline to End of 9th grade, an average of 1 year]

      NIH Toolbox Dimensional Change Card Sort Test

    14. Target Mechanism: Executive Functions (measure 6) [Change from Baseline to End of 9th grade, an average of 1 year]

      observations of planner use (or a device if preferred)

    15. Target Mechanism: Executive Functions (measure 7) [Change from Baseline to End of 9th grade, an average of 1 year]

      bookbag organization. Percentage of classes with recorded homework (or indication of no homework) will be calculated for the last five school days

    16. Target Mechanism: Executive Functions (measure 8) [Change from Baseline to End of 9th grade, an average of 1 year]

      note-taking skills analogue paradigm

    17. Target Mechanism: Executive Functions (measure 9) [Change from Baseline to End of 9th grade, an average of 1 year]

      Adolescent Academic Problems Checklist

    18. Engagement and Fit Measures: Fidelity Checklists [During Intervention Delivery, an average of 1 year]

      % of fidelity items marked yes for treatment and supervision sessions

    19. Engagement and Fit Measures: Intervention Attendance [During Intervention Delivery, an average of 1 year]

      % of intervention sessions attended by student and peers and parents

    20. Engagement and Fit Measures: Parent Academic Involvement [Change from Baseline to End of 9th grade, an average of 1 year]

      Parent Academic Management Scale (PAMS) completed by parent, 0=minimum value 5=maximum value, higher scores mean better outcome

    21. Engagement and Fit Measures: Intervention Credibility [Immediately post-treatment]

      Client Credibility Questionnaire completed by student,and peer interventionist, 0=minimum value 2=maximum value, Higher scores mean a better outcome

    22. Engagement and Fit Measures: Intervention Credibility [Immediately post-treatment]

      Client Credibility Questionnaire completed by parent, 0=minimum value 8=maximum value, Higher scores mean a better outcome

    23. Engagement and Fit Measures: Satisfaction [Immediately post-treatment]

      STRIPES Satisfaction Questionnaire completed by student, peer interventionist, and parent, 1=minimum value 5=maximum value, higher scores mean better outcome

    24. Engagement and Fit Measures: Therapy-Bond and Engagement Scales [Immediately post-treatment]

      Therapy Bond and Engagement Scale completed by student and peers, 1=minimum 4=maximum, higher scores means better outcome

    25. Follow-up Focus Groups and Surveys [Immediately post-treatment]

      Qualitative data collected from parents

    26. Follow-up Focus Groups and Surveys [Immediately post-treatment]

      Qualitative data collected from peers

    27. Follow-up Focus Groups and Surveys [Immediately post-treatment]

      Qualitative data collected from students

    28. Time Varying Covariate: Medication Use [Change from Baseline to End of 9th grade, an average of 1 year]

      Medication Use Interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seattle Children's Hospital Research Institute Seattle Washington United States 98101

    Sponsors and Collaborators

    • Seattle Children's Hospital
    • University of Washington
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Margarret Sibley, Ph.D., Seattle Children's Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Margaret Sibley, Associate Professor of Psychiatry & Behavioral Health, Seattle Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04571320
    Other Study ID Numbers:
    • R34MH122225
    • R34MH122225
    First Posted:
    Oct 1, 2020
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Margaret Sibley, Associate Professor of Psychiatry & Behavioral Health, Seattle Children's Hospital

    Study Results

    No Results Posted as of Jul 11, 2022