Clinical trial NCT06821035: The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
Official title: Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adverse Childhood Experiences
Family Functioning
Keywords: Alcohol and Substance Use Prevention
Youth Risk Behaviors
Traumatized Youth
stress management
adolescent
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Illinois at Chicago
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-11
Enrollment: 210
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: Adverse Childhood Experiences (ACEs) constitute a serious public health issue, impacting almost half of adolescents and over 60% of adults in the United States. High ACEs exposure (i.e., four or more ACEs) may result in self-dysregulation (i.e., challenges managing cognitions, emotions, and behaviors) and lead to early initiation of alcohol and substance use (e.g., self-medication hypothesis) and other biopsychosocial responses, such as cardiometabolic risks (e.g., lowered heart rate variability \[HRV\], increased weight and blood pressure, and sleep disturbance), and emotional and/or cognitive dysregulation. Health inequities resulting from self-dysregulation are highest among minoritized and impoverished populations, who experience disproportionately higher exposure to ACEs, and early adolescence is a time in which experimentation with alcohol and drugs occurs. Although not all adolescents who experiment with drugs are later diagnosed with a substance use disorder, those who engage early (i.e., before the age of 14) and regularly are at greater risk. Youth with four or more ACEs may experience a unique type of adversity characterized by chronic, unpredictable stress shaping their perception of and responses to stress. However certain strategies, called Shift and Persist, can mitigate these exposures where one shifts their attention from adverse experiences to future-directed behaviors (e.g., healthy habit adoption, stress management), resulting in improved self-regulation and lower cardiometabolic risks. GRIT is a community health worker (CHW)-delivered psychoeducational health coaching intervention that promotes coping with high exposure to ACEs to regulate the stress response using self-regulation techniques and the development of healthy habits recommended by the California Surgeon General (e.g., supportive relationships, quality sleep, physical activity). We propose conducting a 2-arm Randomized Controlled Trial (RCT) (GRIT vs an active control \[i.e., digital citizenship\]) with 210 adolescent-caregiver dyads to determine GRIT's impact 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 will: Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. H1: Adolescents enrolled in GRIT will have lower rates of regular alcohol and/or cannabis use at post-intervention, 6-, and 12-month follow-ups compared to adolescents in the active control group. 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. H2: Youth and caregiver self-regulation will mediate youth initiation of regular alcohol and cannabis use. This community-based study seeks to establish efficacy for a brief, accessible secondary prevention program. Once efficacy is established and the mechanism of action is identified, larger confirmatory efficacy studies and effectiveness trials using innovative approaches (i.e. multi-family groups and social media) in additional settings offer the opportunity to scale and decrease the research-to-practice gap for adversity-impacted youth.

Eligibility 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.

Primary outcomes:
measure: Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Secondary outcomes:
measure: Heart Rate Variability Assessment: EmWave Pro
timeFrame: Baseline, immediately after the intervention, 12 months post-intervention
measure: Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Nutrition: CDC Youth Risk Behavior Surveillance System (YRBSS)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Physical Activity: CDC Youth Risk Behavior Surveillance System (YRBSS)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Family Functioning: Family Assessment Device (FAD)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Psychological Flexibility:
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Psychological Flexibility:
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
measure: Psychological Stress: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Other outcomes:
Locations:
city: Irvine
country: United States
facility: The Regents of the University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Dawn T. Bounds, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Norweeta G. Milburn, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of California, Los Angeles
name: Karnik Niranjan, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: University of California, Irvine
name: Shin Sanghyuk, Ph.D.
role: STUDY_DIRECTOR
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