New treatment option for Adverse Childhood Experiences
Official title The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
ClinicalTrials.gov ID: NCT06821035
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 14. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community.
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 14 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.