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NCT Number: NCT06754527

Options for Navigating Talking About Risk and Adolescent Choices

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ON-TRAC

Behavioral

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

Primary outcomes

  1. Timeline Follow Back

    Time frame: Baseline, 2-, 5-, and 8-months

    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.

Secondary outcomes

  1. Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version

    Time frame: Baseline, 2-, 5-, and 8-months

    Assesses self-efficacy to resist alcohol use. Scores range from 9 to 54. Higher scores represent greater drinking refusal self-efficacy.

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

    Time frame: Baseline, 2-, 5-, and 8-months

    Assesses self-efficacy to resist marijuana use. Scores range from 9 to 54. Higher scores represent greater marijuana refusal self-efficacy.

Other outcomes

  1. Youth Risk Behavior Surveillance Survey

    Time frame: Baseline, 2-, 5-, and 8-months

    Single items assess other risk behaviors such as sexual risk or violence behaviors. Endorsement of each individual item indicates engagement in the risk behavior.

  2. Patient-Reported Outcome Measures Information System - Anger Scale

    Time frame: Baseline, 2-, 5-, and 8-months

    Assesses symptoms of mental health and social functioning. Scores range from 5 to 25. Higher scores indicate greater anger.

  3. Difficulties in Emotion Regulation Scale

    Time frame: Baseline, 2-, 5-, and 8-months

    Assesses perceptions of emotion regulation skills. Scores range from 18-90. Higher scores indicate more difficulty regulating emotions.

  4. Emotion Regulation Behaviors Scale

    Time frame: Baseline, 2-, 5-, and 8-months

    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.

  5. Diagnostic Analysis of Nonverbal Accuracy-2

    Time frame: Baseline, 2-, and 8-months

    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.

  6. Behavioral Indicator of Resiliency to Distress

    Time frame: Baseline, 2-, and 8-months

    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.

  7. Self-Efficacy Questionnaire for Children

    Time frame: Baseline, 2-, 5-, and 8-months

    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.

  8. Implicit Theories of Emotions for Children - Self subscale

    Time frame: Baseline, 2-, 5-, and 8-months

    Assesses beliefs about the controllability of emotions. Scores range from 6 to 36. Higher scores indicate stronger beliefs about the controllability of emotions.

  9. Respiratory sinus arrhythmia

    Time frame: Baseline and 2-month follow up

    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.

  10. Feasibility and Acceptability Scale

    Time frame: 2-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.

  11. System Usability Scale

    Time frame: 2-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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Houck, PhD

CONTACT

[email protected]

401-793-8333

Stephanie Parade, PhD

CONTACT

[email protected]

401-793-8247

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

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

Acronym: ON-TRAC

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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