Substance Use (Drugs, Alcohol)ON-TRACNCT06754527
Options for Navigating Talking About Risk and Adolescent Choices
A study testing ON-TRAC in people with Substance Use (Drugs, Alcohol) and Substance Use Risk, run by Rhode Island Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use (Drugs, Alcohol), Substance Use Risk, Substance Use
- What is being tested?
- ON-TRAC
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Emotion Regulation Intervention to Prevent Substance Use Among Youth in the Child Welfare System
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
- Being tested
- ON-TRAC
- Keywords
- adolescent substance use, emotion regulation, risk reduction
- Medical subject headings
- Substance-Related Disorders, Emotional Regulation, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON-TRACBehavioural
Online tablet-based intervention that teaches youth emotion regulation skills and integrates substance use prevention content
| Study group | Role | What they receive |
|---|---|---|
| ON-TRAC Intervention | Experimental | Web-based emotion regulation and substance use intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2-, 5-, and 8-months
Secondary outcomes (2)
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.
Measured: Baseline, 2-, 5-, and 8-months
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.
Measured: Baseline, 2-, 5-, and 8-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use (Drugs, Alcohol)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754527
- Sponsor's protocol ID
- ON-TRAC (unknown Protocol ID)
- Other IDs
- R61DA059785
- Acronym
- ON-TRAC
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Intervention to Prevent Substance Use Among Youth in the Child Welfare System
- ClinicalTrials.gov ID
- NCT06754527
- Acronym / sponsor ID
- ON-TRAC / ON-TRAC (unknown Protocol ID)
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON-TRAC Intervention | Experimental | Behavioral: ON-TRACWeb-based emotion regulation and substance use intervention |
| 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 |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ON-TRACOnline tablet-based intervention that teaches youth emotion regulation skills and integrates substance use prevention content | Behavioural | ON-TRAC Intervention |
Primary outcome
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.
2 secondary outcomes
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version
Time frame: Baseline, 2-, 5-, and 8-months
Drinking Refusal Self-Efficacy Questionnaire - Shortened Adolescent Version (Adapted for Marijuana Use)
Time frame: Baseline, 2-, 5-, and 8-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ON-TRAC in people with Substance Use (Drugs, Alcohol) and Substance Use Risk, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Houck, PhD (401-793-8333, CHouck@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow Back (time frame: Baseline, 2-, 5-, and 8-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.