- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06638853
Piloting a School-Based Distress Tolerance Skills Program for Adolescents (STRIDE)
The STRIDE Study (Strengthening Tolerance and Resilience in Dealing with Emotions): Pilot Testing of a School-Based Distress Tolerance Skills Program for Reducing Risk of Psychopathology in Adolescence
Study Overview
Status
Intervention / Treatment
Detailed Description
A variety of deleterious mental health conditions have their peak age of onset in adolescence, including depression and anxiety. Distress tolerance (DT) - defined as the perceived or actual ability to withstand aversive emotional states - has been postulated as a transdiagnostic risk factor across several "emotional" disorders that typically emerge during adolescence. Importantly, while there is compelling evidence that DT is associated with emotion dysregulation and symptom severity, it is unclear whether modifying DT can reduce future risk for psychopathology in adolescent populations. This proposal aims to evaluate the feasibility, acceptability, and initial efficacy of a classroom-based DT intervention for middle school students. Additionally, this proposal will examine associations between changes in DT and internalizing symptoms.
Primary Objective:
To evaluate the acceptability, feasibility, and efficacy of a classroom-based DT skills training program for middle school students.
Secondary Objectives:
To examine whether participation in the DT skills training program is associated with lower severity of internalizing symptoms over the course of the academic year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Beaverton, Oregon, United States, 97078
- Valley Catholic Middle School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Middle school aged-youth attending Valley Catholic Middle School in grade 6, 7, or 8
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Distress Tolerance Skills Training
Students will participate in a series of classroom-based lessons aimed at increasing distress tolerance.
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These lessons are adapted from "DBT Skills in Schools: Skills Training for Emotional Problem Solving for Adolescents (DBT STEPS-A)" by Mazza et al. and include elements of mindfulness training, psychoeducation about emotions, and techniques/skills for managing extreme emotions.
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No Intervention: Standard Curriculum (Control)
Students will not participate in the distress tolerance skills training.
They will receive only their standard curriculum during class time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: Pre-intervention and immediately post-intervention
|
Consent rates during enrollment and attrition rates during the study will be used to assess the feasibility of the intervention.
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Pre-intervention and immediately post-intervention
|
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Acceptability
Time Frame: Immediately post-intervention
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The investigators will use a brief feedback survey at the end of the study to gather information about participants' experiences of the intervention.
Responses on this survey will be used to determine the acceptability of the intervention.
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Immediately post-intervention
|
|
Distress Tolerance
Time Frame: Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up
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The investigators will assess change in distress tolerance from pre-intervention to post-intervention.
Distress tolerance will be indexed by total scores on the Distress Tolerance Scale (DTS), which is a 15-item self-report measure that assesses the respondent's perceived ability to withstand distressing or upsetting emotional states.
Possible total scores can range from 15 to 75.
Higher scores indicate higher distress tolerance.
This outcome measure will be examined and compared for both the intervention group and the control group.
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Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internalizing Symptoms
Time Frame: Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up
|
The investigators will assess change in internalizing symptoms from pre-intervention to post-intervention and periodically during follow-up.
Internalizing symptoms will be measured using the ASEBA Youth Self-Report (YSR).
Possible raw scores on the Internalizing Symptoms Subscale can range from 0 to 62. Raw scores are transformed to standardized T-scores normed by age and gender and can range from 26 to 100.
Higher scores indicate greater symptoms.
This outcome measure will be examined and compared for both the intervention group and the control group.
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Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bonnie Nagel, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00027611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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