Teaching healthy regulation to adolescents in challenging environments
Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
NA · University of California, Irvine · NCT06821035
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 11 Years to 14 Years |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06821035 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have recently used alcohol or cannabis or are in acute distress may not benefit from this intervention.
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 performed: 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.
Eligibility criteria
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 this trial is running
Irvine, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adverse Childhood Experiences, Family Functioning, Alcohol and Substance Use Prevention, Youth Risk Behaviors, Traumatized Youth, stress management, adolescent