NCT04571320

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, and ADHD symptoms (parent and teacher report).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

August 31, 2020

Results QC Date

December 1, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

ADHDSchool-basedPeer-deliveredAdolescence

Outcome Measures

Primary Outcomes (3)

  • Grade Point Average

    Report cards were obtained directly from schools. GPA for each quarter was calculated by converting academic grades (e.g., English, Math, Science, Social Studies) to a 5-point scale (i.e., 4.0=A to 0.0=F). Grades were not weighted for class difficulty.

    Change from Baseline to End of 9th grade, an average of 1 year

  • Class Attendance

    Number of Class Absences per Academic Quarter

    Change from Baseline to End of 9th grade, an average of 1 year

  • Attention Deficit Hyperactivity Disorder Symptom Severity

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

    Change from Baseline to End of 9th grade, an average of 1 year

Other Outcomes (24)

  • Target Mechanism: Extrinsic Motivation (Measure 1)

    Change from Baseline to End of 9th grade, an average of 1 year

  • Target Mechanism: Extrinsic Motivation (Measure 2)

    Change from Baseline to End of 9th grade, an average of 1 year

  • Target Mechanism: Extrinsic Motivation (Measure 3)

    Change from Baseline to End of 9th grade, an average of 1 year

  • +21 more other outcomes

Study Arms (2)

Summer STRIPES

EXPERIMENTAL

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

Enhanced School Services as Usual

ACTIVE COMPARATOR

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

Interventions

Summer STRIPESBEHAVIORAL

See arm description.

Summer STRIPES

see arm description.

Also known as: SSU plus
Enhanced School Services as Usual

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Placement in special education classes
  • IQ \< 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

A limitation of this study is its moderate sample size (N=72), which prevented detection of smaller effects. We did not impose Type I error corrections because this initial phase of intervention testing prioritizes hypothesis and theoretical model building prior to a future large-scale clinical trial. This study was conducted in the post-COVID-19 school environment (2022-2024) and most parents were highly educated (over 80% had at least one parent with a bachelors degree).

Results Point of Contact

Title
Margaret Sibley
Organization
Seattle Children's Research Institute

Study Officials

  • Margarret Sibley, Ph.D.

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Only adolescents are randomly assigned to group. parents/teachers were not considered enrolled, and their involvement was limited to providing ratings and/or optional attendance as part of the treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry & Behavioral Health

Study Record Dates

First Submitted

August 31, 2020

First Posted

October 1, 2020

Study Start

June 3, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 5, 2026

Results First Posted

March 5, 2026

Record last verified: 2026-02

Locations