Options for Navigating Talking About Risk and Adolescent Choices (ON-TRAC)

Emotion Regulation Intervention to Prevent Substance Use Among Youth in the Child Welfare System

This study will examine the effectiveness of ON-TRAC (Options for Navigating Talking about Risk and Adolescent Choices), which is an online substance use prevention program that also teaches emotion regulation skills. 200 adolescents, 12-15 years of age, will be randomized to ON-TRAC or a wait list comparison group (who will be offered the intervention at the end of their study participation) to determine impact on substance use, emotion regulation abilities, mental health symptoms, and other risk behavior outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use; Risk Reduction; Emotion Regulation; Risk Reduction Behavior; Substance Use (Drugs, Alcohol); Substance Use Risk
• Intervention / Treatment: Behavioral: ON-TRAC

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Parade, PhD; Phone Number: 401-793-8247; Email: stephanie_parade@brown.edu
• Study Contact Backup: Name: Christopher Houck, PhD; Phone Number: 401-793-8333; Email: CHouck@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Contact with the Rhode Island child welfare system
• Caregiver who is a parent/guardian of a child who experienced maltreatment
• Caregiver who speaks English or Spanish
• Caregiver who does not have developmental delays
• Adolescent who is between 12-15 years of age
• Adolescent who is fluent in English
• Adolescent who has active follow-up with the Rhode Island child welfare system due to an indicated finding of abuse or neglect in the past year

Exclusion Criteria:

• Adolescent who cannot read at a 4th grade level
• Adolescent who has a sibling who has participated in the program
• Adolescent who has developmental delays
• Adolescent who lacks parental consent for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ON-TRAC Intervention; Web-based emotion regulation and substance use intervention	Behavioral: ON-TRAC; Online tablet-based intervention that teaches youth emotion regulation skills and integrates substance use prevention content
No Intervention: Waitlist Control; Control participants are assessed on the same schedule as the treatment condition and offered the intervention after the 8-month follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow Back	A calendar assisted daily substance use estimation method obtained by interview. Days used will serve as primary outcome. More days used represent more substance use.	Baseline, 2-, 5-, and 8-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version	Assesses self-efficacy to resist alcohol use. Scores range from 9 to 54. Higher scores represent greater drinking refusal self-efficacy.	Baseline, 2-, 5-, and 8-months
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version (Adapted for Marijuana Use)	Assesses self-efficacy to resist marijuana use. Scores range from 9 to 54. Higher scores represent greater marijuana refusal self-efficacy.	Baseline, 2-, 5-, and 8-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Youth Risk Behavior Surveillance Survey	Single items assess other risk behaviors such as sexual risk or violence behaviors. Endorsement of each individual item indicates engagement in the risk behavior.	Baseline, 2-, 5-, and 8-months
Patient-Reported Outcome Measures Information System - Anger Scale	Assesses symptoms of mental health and social functioning. Scores range from 5 to 25. Higher scores indicate greater anger.	Baseline, 2-, 5-, and 8-months
Difficulties in Emotion Regulation Scale	Assesses perceptions of emotion regulation skills. Scores range from 18-90. Higher scores indicate more difficulty regulating emotions.	Baseline, 2-, 5-, and 8-months
Emotion Regulation Behaviors Scale	Assesses use of emotion regulation behaviors taught in the intervention. Scores range from 9 to 36. Higher scores indicate more frequent use of the strategies taught.	Baseline, 2-, 5-, and 8-months
Diagnostic Analysis of Nonverbal Accuracy-2	Computer-based measure that asks participants to identify the emotion of facial expressions displayed in photographs. Scores range from 0 to 20. Higher scores indicate better identification of emotions.	Baseline, 2-, and 8-months
Behavioral Indicator of Resiliency to Distress	Computerized frustration task in which participants are given the option to quit at any time. Scores range from 0 to 300 seconds. Higher scores indicate more persistence in a frustrating task.	Baseline, 2-, and 8-months
Self-Efficacy Questionnaire for Children	Assesses perception of ability to cope with negative emotions. Scores range from 8 to 40. Higher scores indicate greater perceived ability to cope with negative emotions.	Baseline, 2-, 5-, and 8-months
Implicit Theories of Emotions for Children - Self subscale	Assesses beliefs about the controllability of emotions. Scores range from 6 to 36. Higher scores indicate stronger beliefs about the controllability of emotions.	Baseline, 2-, 5-, and 8-months
Respiratory sinus arrhythmia	Collected in response to virtual reality scenes, RSA is a physiological marker of emotion regulation processes calculated from heart rate variability as an index of parasympathetic activity.	Baseline and 2-month follow up
Feasibility and Acceptability Scale	Assesses acceptability of digital interventions to assess implementation outcomes. Scores range from 5 to 25. Higher scores indicate greater acceptability of the intervention.	2-month follow-up (ON-TRAC group only)
System Usability Scale	Assesses usability of technology programs to assess implementation outcomes. Scores range from 10 to 50. Higher scores indicate greater usability of the intervention.	2-month follow-up (ON-TRAC group only)

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: emotion regulation; risk reduction; adolescent substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: ON-TRAC (unknown Protocol ID); R61DA059785 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No