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

NCT ID: NCT04571320

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Summer STRIPES

Intervention Type BEHAVIORAL

See arm description.

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.

Group Type ACTIVE_COMPARATOR

Enhanced School Services as Usual

Intervention Type OTHER

see arm description.

Interventions

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Summer STRIPES

See arm description.

Intervention Type BEHAVIORAL

Enhanced School Services as Usual

see arm description.

Intervention Type OTHER

Other Intervention Names

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SSU plus

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margaret Sibley

Associate Professor of Psychiatry & Behavioral Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margarret Sibley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34344674 (View on PubMed)

Other Identifiers

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R34MH122225

Identifier Type: NIH

Identifier Source: secondary_id

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R34MH122225

Identifier Type: NIH

Identifier Source: org_study_id

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