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

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Summer STRIPES
Enhanced School Services as Usual
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ADHD focused on measuring ADHD, School-based, Peer-delivered, Adolescence

Eligibility Criteria

13 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's Hospital Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Summer STRIPES

Enhanced School Services as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Grade Point Average
Quarterly Student Grade Point Average from Report Cards
Class Attendance
Number of Class Absences per Academic Quarter
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2020
Last Updated
July 7, 2022
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04571320
Brief Title
A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Acronym
Summer STRIPES
Official Title
A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, School-based, Peer-delivered, Adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Summer STRIPES
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced School Services as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Summer STRIPES
Intervention Description
See arm description.
Intervention Type
Other
Intervention Name(s)
Enhanced School Services as Usual
Other Intervention Name(s)
SSU plus
Intervention Description
see arm description.
Primary Outcome Measure Information:
Title
Grade Point Average
Description
Quarterly Student Grade Point Average from Report Cards
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Class Attendance
Description
Number of Class Absences per Academic Quarter
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Attention Deficit Hyperactivity Disorder Symptom Severity
Description
Parent and Teacher Rated ADHD Symptoms on DSM-5 ADHD Checklist, 0=minimum, 3=maximum, Higher score means worse outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Target Mechanism: Extrinsic Motivation (measure 1)
Description
Expectancy Value Theory of Motivation Measure (Student Report); Importance Subscale 1=minimum, 5=maximum, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Extrinsic Motivation (measure 2)
Description
Hungry Donkey Task (IOWA Gambling Task) --Risky Decision Making
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Extrinsic Motivation (measure 3)
Description
Delay Discounting measured on Choice Delay task (total amount of money earned)
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Extrinsic Motivation (measure 4)
Description
The Change Ruler self-report, 1=minimum value 10=maximum value, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Intrinsic Motivation (measure 1)
Description
Expectancy-Value Theory of Motivation Measure-Student Version, Interest subscale, 1=minimum, 5=maximum, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Intrinsic Motivation (measure 2)
Description
Delay Aversion; Quick Delay Questionnaire (self-report), 1=minimum value 5=maximum value, higher scores better outcomes, items 5-10 reverse coded
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Intrinsic Motivation (measure 3)
Description
Change Ruler Scale self-report, 1=minimum value 10=maximum value, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Intrinsic Motivation (measure 4)
Description
Basic Psychological Needs Scale self-report, 1=minimum value 6=maximum value, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 1)
Description
parent report: goal setting and planning section of the Self-Regulated Learning Interview Schedule
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 2)
Description
Behavior Rating Index of Executive Function (BRIEF-2) parent report
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 3)
Description
National Institute of Health (NIH) Toolbox List Sorting Working Memory Test
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 4)
Description
go/no-go task (number of commission errors on no-go trials)
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 5)
Description
NIH Toolbox Dimensional Change Card Sort Test
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 6)
Description
observations of planner use (or a device if preferred)
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 7)
Description
bookbag organization. Percentage of classes with recorded homework (or indication of no homework) will be calculated for the last five school days
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 8)
Description
note-taking skills analogue paradigm
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Target Mechanism: Executive Functions (measure 9)
Description
Adolescent Academic Problems Checklist
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Engagement and Fit Measures: Fidelity Checklists
Description
% of fidelity items marked yes for treatment and supervision sessions
Time Frame
During Intervention Delivery, an average of 1 year
Title
Engagement and Fit Measures: Intervention Attendance
Description
% of intervention sessions attended by student and peers and parents
Time Frame
During Intervention Delivery, an average of 1 year
Title
Engagement and Fit Measures: Parent Academic Involvement
Description
Parent Academic Management Scale (PAMS) completed by parent, 0=minimum value 5=maximum value, higher scores mean better outcome
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year
Title
Engagement and Fit Measures: Intervention Credibility
Description
Client Credibility Questionnaire completed by student,and peer interventionist, 0=minimum value 2=maximum value, Higher scores mean a better outcome
Time Frame
Immediately post-treatment
Title
Engagement and Fit Measures: Intervention Credibility
Description
Client Credibility Questionnaire completed by parent, 0=minimum value 8=maximum value, Higher scores mean a better outcome
Time Frame
Immediately post-treatment
Title
Engagement and Fit Measures: Satisfaction
Description
STRIPES Satisfaction Questionnaire completed by student, peer interventionist, and parent, 1=minimum value 5=maximum value, higher scores mean better outcome
Time Frame
Immediately post-treatment
Title
Engagement and Fit Measures: Therapy-Bond and Engagement Scales
Description
Therapy Bond and Engagement Scale completed by student and peers, 1=minimum 4=maximum, higher scores means better outcome
Time Frame
Immediately post-treatment
Title
Follow-up Focus Groups and Surveys
Description
Qualitative data collected from parents
Time Frame
Immediately post-treatment
Title
Follow-up Focus Groups and Surveys
Description
Qualitative data collected from peers
Time Frame
Immediately post-treatment
Title
Follow-up Focus Groups and Surveys
Description
Qualitative data collected from students
Time Frame
Immediately post-treatment
Title
Time Varying Covariate: Medication Use
Description
Medication Use Interview
Time Frame
Change from Baseline to End of 9th grade, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mercedes Ortiz, BA
Phone
206-884-8260
Email
mercedes.ortizrodriguez@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarret Sibley, Ph.D.
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret H Sibely, PhD
Phone
206-884-1424
Email
margaret.sibley@seattlechildrens.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
34344674
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.
Results Reference
derived

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

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