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Options for Navigating Talking About Risk and Adolescent Choices

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754527
Acronym
ON-TRAC
Enrollment
200
Registered
2025-01-01
Start date
2026-03-01
Completion date
2029-02-01
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

adolescent substance use, emotion regulation, risk reduction

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.

Interventions

BEHAVIORALON-TRAC

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

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Timeline Follow BackBaseline, 2-, 5-, and 8-monthsA calendar assisted daily substance use estimation method obtained by interview. Days used will serve as primary outcome. More days used represent more substance use.

Secondary

MeasureTime frameDescription
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent VersionBaseline, 2-, 5-, and 8-monthsAssesses self-efficacy to resist alcohol use. Scores range from 9 to 54. Higher scores represent greater drinking refusal self-efficacy.
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version (Adapted for Marijuana Use)Baseline, 2-, 5-, and 8-monthsAssesses self-efficacy to resist marijuana use. Scores range from 9 to 54. Higher scores represent greater marijuana refusal self-efficacy.

Other

MeasureTime frameDescription
Emotion Regulation Behaviors ScaleBaseline, 2-, 5-, and 8-monthsAssesses 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.
Diagnostic Analysis of Nonverbal Accuracy-2Baseline, 2-, and 8-monthsComputer-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.
Behavioral Indicator of Resiliency to DistressBaseline, 2-, and 8-monthsComputerized 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.
Self-Efficacy Questionnaire for ChildrenBaseline, 2-, 5-, and 8-monthsAssesses 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.
Youth Risk Behavior Surveillance SurveyBaseline, 2-, 5-, and 8-monthsSingle items assess other risk behaviors such as sexual risk or violence behaviors. Endorsement of each individual item indicates engagement in the risk behavior.
Respiratory sinus arrhythmiaBaseline and 2-month follow upCollected 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.
Feasibility and Acceptability Scale2-month follow-up (ON-TRAC group only)Assesses acceptability of digital interventions to assess implementation outcomes. Scores range from 5 to 25. Higher scores indicate greater acceptability of the intervention.
System Usability Scale2-month follow-up (ON-TRAC group only)Assesses usability of technology programs to assess implementation outcomes. Scores range from 10 to 50. Higher scores indicate greater usability of the intervention.
Implicit Theories of Emotions for Children - Self subscaleBaseline, 2-, 5-, and 8-monthsAssesses beliefs about the controllability of emotions. Scores range from 6 to 36. Higher scores indicate stronger beliefs about the controllability of emotions.
Patient-Reported Outcome Measures Information System - Anger ScaleBaseline, 2-, 5-, and 8-monthsAssesses symptoms of mental health and social functioning. Scores range from 5 to 25. Higher scores indicate greater anger.
Difficulties in Emotion Regulation ScaleBaseline, 2-, 5-, and 8-monthsAssesses perceptions of emotion regulation skills. Scores range from 18-90. Higher scores indicate more difficulty regulating emotions.

Contacts

Primary ContactChristopher Houck, PhD
CHouck@brownhealth.org401-793-8333
Backup ContactStephanie Parade, PhD
stephanie_parade@brown.edu401-793-8247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026