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

• ClinicalTrials.gov Identifier: NCT04571320
• Recruitment Status: Recruiting
• First Posted: October 1, 2020
• Last Update Posted: July 11, 2022
• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Margaret Sibley, Seattle Children's Hospital

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
ADHD	Behavioral: Summer STRIPES; Other: Enhanced School Services as Usual	Not Applicable

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 (Clinical Trial)
• Estimated 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: June 3, 2022
• Estimated Primary Completion Date: July 31, 2024
• Estimated Study Completion Date: July 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 Name: SSU plus

Outcome Measures

Primary Outcome Measures :

1. Grade Point Average [ Time Frame: Change from Baseline to End of 9th grade, an average of 1 year ]
   Quarterly Student Grade Point Average from Report Cards
2. Class Attendance [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change from Baseline to End of 9th grade, an average of 1 year ]
    Adolescent Academic Problems Checklist
18. Engagement and Fit Measures: Fidelity Checklists [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Immediately post-treatment ]
    Qualitative data collected from parents
26. Follow-up Focus Groups and Surveys [ Time Frame: Immediately post-treatment ]
    Qualitative data collected from peers
27. Follow-up Focus Groups and Surveys [ Time Frame: Immediately post-treatment ]
    Qualitative data collected from students
28. Time Varying Covariate: Medication Use [ Time Frame: Change from Baseline to End of 9th grade, an average of 1 year ]
    Medication Use Interview

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Mercedes Ortiz, BA; 206-884-8260; mercedes.ortizrodriguez@seattlechildrens.org

Locations

United States, Washington

Seattle Children's Hospital Research Institute; Recruiting

Seattle, Washington, United States, 98101

Contact: Margaret H Sibely, PhD 206-884-1424 margaret.sibley@seattlechildrens.org

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Margaret Sibley, Associate Professor of Psychiatry & Behavioral Health, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT04571320
• Other Study ID Numbers: R34MH122225 ( U.S. NIH Grant/Contract ); R34MH122225 ( U.S. NIH Grant/Contract )
• First Posted: October 1, 2020
• Last Update Posted: July 11, 2022
• Last Verified: July 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Margaret Sibley, Seattle Children's Hospital:

ADHD; School-based; Peer-delivered; Adolescence