Clinical trial Recruiting at 1 site Interventional Ages 11 to 14

Teaching healthy regulation to adolescents in challenging environments

Official title: Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth

Run by University of California, Irvine · NCT06821035 · Data updated 2026-11-12

This study is testing a coaching program called GRIT to see if it can help young teens who have faced tough challenges avoid using alcohol and cannabis.

Quick facts

Study typeInterventional
Ages11 Years to 14 Years
SexAll
Enrollment210 (estimated)
SponsorUniversity of California, Irvine
Academic / other
Locations1 site (Irvine, California)
StatusRecruiting
StartedApril 17, 2025
Main results expectedAugust 31, 2028
Study endsAugust 31, 2028
Registry record updatedMarch 18, 2026
Trial IDNCT06821035 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents aged 11-14 who have experienced four or more Adverse Childhood Experiences and do not currently use alcohol or cannabis.

Probably not a fit

Patients who have recently used alcohol or cannabis or are in acute distress may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a coaching intervention called GRIT, delivered by community health workers, in preventing early alcohol and cannabis use among adolescents aged 11-14 who have experienced significant adversity. Participants will be randomly assigned to either the GRIT intervention or an active control group receiving a Digital Citizenship Curriculum. The study will assess the impact of GRIT on self-regulation and cardiometabolic risks over time, focusing on youth and caregiver dynamics. By addressing the effects of Adverse Childhood Experiences (ACEs), the trial seeks to improve health outcomes for at-risk youth.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the early initiation of substance use among vulnerable adolescents, leading to better long-term health outcomes.

How similar studies have gone: Other studies have shown promise in using similar interventions to address substance use prevention among at-risk youth, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Regents of the University of California, Irvine
    Irvine, California, United States
    Recruiting

Study contacts

  • Principal investigator: Dawn T. Bounds, Ph.D. — University of California, Irvine
  • Study coordinator: Dawn T. Bounds, Ph.D.
  • Email: boundsd@hs.uci.edu
  • Phone: 949-742-7109

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.