Clinical trial NCT06754527: Options for Navigating Talking About Risk and Adolescent Choices
Official title: Emotion Regulation Intervention to Prevent Substance Use Among Youth in the Child Welfare System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Timeline Follow Back
timeFrame: Baseline, 2-, 5-, and 8-months
Secondary outcomes:
measure: Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version (Adapted for Marijuana Use)
timeFrame: Baseline, 2-, 5-, and 8-months
Other outcomes:
measure: Youth Risk Behavior Surveillance Survey
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Patient-Reported Outcome Measures Information System - Anger Scale
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Difficulties in Emotion Regulation Scale
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Emotion Regulation Behaviors Scale
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Diagnostic Analysis of Nonverbal Accuracy-2
timeFrame: Baseline, 2-, and 8-months
measure: Behavioral Indicator of Resiliency to Distress
timeFrame: Baseline, 2-, and 8-months
measure: Self-Efficacy Questionnaire for Children
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Implicit Theories of Emotions for Children - Self subscale
timeFrame: Baseline, 2-, 5-, and 8-months
measure: Respiratory sinus arrhythmia
timeFrame: Baseline and 2-month follow up
measure: Feasibility and Acceptability Scale
timeFrame: 2-month follow-up (ON-TRAC group only)
measure: System Usability Scale
timeFrame: 2-month follow-up (ON-TRAC group only)
Locations:
Study officials:
References: