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

ADHD Clinical Trial

— Summer STRIPES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571320
• Other study ID #: R34MH122225
• Secondary ID: R34MH122225
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2022
• Source: Seattle Children's Hospital
• Contact: Mercedes Ortiz, BA
• Phone: 206-884-8260
• Email: mercedes.ortizrodriguez[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Summer STRIPES
See arm description.

Other:
• Enhanced School Services as Usual
see arm description.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Institute of Mental Health (NIMH), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

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