GRIT Intervention for Adverse Childhood Experiences

Overseen By Jenny Fotang

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Recent alcohol or cannabis use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

210 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include: * Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. * Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use. Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks. Participants will: * Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group) * Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention * Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits. * Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker * Be invited to complete a booster session at 6-months post-intervention * Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention

Research Team

Dawn T. Bounds, Ph.D.

Principal Investigator

University of California, Irvine

Norweeta G. Milburn, Ph.D.

Principal Investigator

University of California, Los Angeles

Karnik Niranjan, M.D., Ph.D.

Principal Investigator

University of California, Los Angeles

Shin Sanghyuk, Ph.D.

Principal Investigator

University of California, Irvine

Eligibility Criteria

The THRIVE Study is for adolescents aged 11-14 who have faced adverse childhood experiences and do not regularly use alcohol or cannabis. They must be able to attend three in-person visits, participate in Zoom sessions, and complete online measures over a year.

Inclusion Criteria

Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)

I can speak and read English.

I am aged 11-14 and have a high-risk score for childhood stress.

Exclusion Criteria

I have used alcohol or cannabis in the last 14 days.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the GRIT intervention or the Digital Citizenship Curriculum over 8 weeks

8 weeks

6 sessions (virtual)

Post-Intervention Assessment

Participants complete in-person and online assessments immediately after the intervention

1 week

1 visit (in-person), online measures

Booster Session

Participants are invited to complete a booster session at 6 months post-intervention

1 session

Follow-up

Participants are monitored for safety and effectiveness at 6 and 12 months post-intervention

12 months

2 visits (in-person), online measures

Treatment Details

Interventions

• Digital Citizenship Curriculum (DCC)
• Garnering Resilience in Traumatized youth and families (GRIT)

Trial Overview This study tests if the GRIT program helps prevent early regular use of alcohol and cannabis better than a Digital Citizenship Curriculum. It involves coaching by community health workers, heart rate variability assessments, surveys, and follow-up booster sessions.

Participant Groups

Group I: GRIT Intervention Experimental Treatment 1 Intervention

Group II: Digital Citizenship Curriculumn Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+