Options for Navigating Talking About Risk and Adolescent Choices

NCT06754527 | Not Yet Recruiting

• 2 other identifiers: ON-TRAC (unknown Protocol ID)R61DA059785
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Substance Use (Drugs, Alcohol); Substance Use Risk; Substance Use; Emotion Regulation; Risk Reduction Behavior; Risk Reduction

Keywords

adolescent substance use; emotion regulation; risk reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version

  Baseline, 2-, 5-, and 8-months

• Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version (Adapted for Marijuana Use)

  Baseline, 2-, 5-, and 8-months

Other Outcomes (11)

• Youth Risk Behavior Surveillance Survey

  Baseline, 2-, 5-, and 8-months

• Patient-Reported Outcome Measures Information System - Anger Scale

  Baseline, 2-, 5-, and 8-months

• Difficulties in Emotion Regulation Scale

  Baseline, 2-, 5-, and 8-months

Study Arms (2)

ON-TRAC Intervention

EXPERIMENTAL

Web-based emotion regulation and substance use intervention

Behavioral: ON-TRAC

Waitlist Control

NO INTERVENTION

Control participants are assessed on the same schedule as the treatment condition and offered the intervention after the 8-month follow-up

Interventions

ON-TRAC BEHAVIORAL

Online tablet-based intervention that teaches youth emotion regulation skills and integrates substance use prevention content

ON-TRAC Intervention

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

MeSH Terms

Conditions

Substance-Related Disorders; Emotional Regulation; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Christopher Houck, PhD

CONTACT

401-793-8333; CHouck@brownhealth.org

Stephanie Parade, PhD

CONTACT

401-793-8247; stephanie_parade@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 1, 2025

Record last verified: 2024-12