Options for Navigating Talking About Risk and Adolescent Choices

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-15
SponsorRhode Island Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ON-TRAC

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ON-TRAC InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

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

Other outcomes

1

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.

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

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.

Time frame
Baseline, 2-, 5-, and 8-months
3

Difficulties in Emotion Regulation Scale

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

Time frame
Baseline, 2-, 5-, and 8-months
4

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.

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

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: