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New program aims to stop substance use before it starts in teens who've faced adversity

NCT ID NCT06821035

Prevention Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a program called GRIT, where community health workers coach teens (ages 11-14) and their families over six weekly sessions. The goal is to help teens who have experienced four or more adverse childhood events build self-regulation skills and avoid starting regular alcohol or cannabis use. Half the families get the GRIT coaching; the other half receive a digital citizenship course. Researchers will follow both groups for a year to see which teens are less likely to start using substances.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
community health worker coaching with heart rate variability biofeedback
What this could lead to
If it works, this could provide a practical, non-drug way to help at-risk teens avoid early substance use and improve their long-term health.
What could go wrong
This is an early-stage study with 210 participants, so results may not apply to all teens. The intervention is time-intensive and relies on family engagement, which may limit real-world uptake.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 14 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Youth ages 11-14 years who score in the High-Risk category (i.e., 4 or more ACEs) on the ACEs and Toxic Stress Risk Assessment Algorithm * Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone) * Youth who are able to speak and read in English * Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention. Exclusion Criteria: * Youth who cannot speak and read in English * Youth who report any alcohol or cannabis use within the last 14 days * Youth currently enrolled in another family-based intervention (i.e., family therapy) * Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis) * Youth who report their caregivers' home environment is unsafe to return to, have been deemed unsafe, or require supervised visits by the Department of Children and Family Services (DCFS) * Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community. * Due to drug experimentation being common in adolescence, our interest in preventing the early initiation of regular use of alcohol and cannabis use, and youth who regularly use substances requiring a different intervention, we will enroll youth who initially report recent cannabis use but later report no use within the last two weeks and have a confirmatory negative urine drug screening.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse childhood experiences Family functioning

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Regents of the University of California, Irvine

    RECRUITING

    Irvine, California, 92697-7600, United States

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