Clinical trial NCT04160754: Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change
Official title: Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Underage
Alcohol Problem Drinking
Substance Use
Keywords: Trauma
Delinquency
Substance Use
Emotion Regulation
Impulsivity
Executive Functioning
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be the first to explore mindfulness as a prevention intervention among transition age youth and those with previous involvement in the juvenile or criminal justice system with substance use problems and history of exposure to violence/trauma. The study will focus on preventing escalation of substance use (e.g., alcohol and marijuana), trauma symptoms, and recidivism by using an intervention to target self-regulation and executive functioning.

Justice involved youth have higher rates of alcohol use and related consequences and higher rates of exposure to violence (Post Traumatic Stress Disorder) compared to their non-justice involved peers. Prior research has found aspects of self-regulation (emotion regulation, impulse control), stress, and craving to be important putative targets in reducing alcohol use. With high rates of recidivism and increased risk of long term problems associated with substance use, it is imperative to test interventions that can reach at risk youth and target both alcohol use and important psychological and neurocognitive self-regulation mechanisms.

This study tests whether the use of Mindfulness-Based Relapse Prevention (MBRP) for at risk young adults results in changes in important self-regulation mechanisms and improved alcohol use outcomes. Individuals assigned to the experimental group will receive interventions normally provided at a community clinic and eight 1.5-hour group sessions of MBRP. Sessions will occur once per week. Each session will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Further, each session will incorporate a mindfulness meditation technique.

The central hypothesis will be tested through a focus on three specific aims: (1) Beta pilot testing and refining MBRP based on feedback from focus groups, (2) testing the efficacy of MBRP on substance use outcomes compared to an active control, and (3) assessing mechanisms of change for MBRP including self-regulation and neurocognitive facets such as working memory and inhibition.

Detailed description: The long-term goal of this proposal is to improve alcohol use outcomes by targeting emotion regulation (ER), impulsivity (IMP), and executive functioning (EF) constructs among racially and ethnically diverse (primarily Hispanic and Black) at risk young adults. With a similar population, the investigators pilot tested a novel Mindfulness-Based Intervention (MBI), Mindfulness-Based Substance Abuse Treatment for Adolescents (MBRP) with with marginalized young adults. Findings from adolescent samples have found support for the intervention's effect on problem behaviors, decision making, and self-esteem. However, extent research in this area has not assessed substance use or self-regulation. In a sample of marginalized young adults receiving treatment at a residential treatment facility, MBRP was found to significantly decrease stress and substance use outcomes. In addition, only one study has investigated the effect of a MBI on neurocognitive functioning with justice-involved youth. Unfortunately, this was not a clinical intervention and did not assess EF as a mechanism of change. The current study proposes to recruit 70-80 young adults (aged 18-26) referred to one clinic in Los Angeles, CA. The study site has a wide range of referral sources ranging from self-referral to referrals from the justice system.

Some young adults are referred to treatment by schools in lieu of engaging law enforcement or in lieu of expulsion, with many being self-referred.

Participants will be randomly assigned to receive MBRP or attention control (CTL). Participants will engage in both self-report and task-based ER, IMP, and EF measures pre- and post-intervention. Participants will be followed for 3 months post-intervention to assess effects on alcohol use and behavioral health outcomes, and putative mechanisms of change.

The central hypothesis is that MBRP, compared to CTL, will prompt change in ER, IMP, and EF. Further, it is hypothesized that these changes will be associated with better alcohol use outcomes 3 months post-intervention. The rationale for using a MBI with marginalized youth is that prior research has shown significantly worse self-regulation compared to community youth, and MBRP is specifically designed to aid in regulating emotions, decision making, and attention control. The unique strengths of this proposal are its use of an MBI; focus on a disadvantaged population of diverse racial and ethnic groups; focus on putative targets essential to behavioral health outcomes; and use of multiple neurocognitive tasks addressing important self-regulation components. The study objective is to test following three aims:

Specific Aim 1: Determine feasibility and acceptability of abbreviated MBRP. An adapted MBRP protocol will be beta-tested with 15 transition age youth/young adults. Focus groups will be conducted to evaluate the feasibility and acceptability of an intervention focused on enhancing self-regulation, refine content based on feedback, and addressing issues that might affect the successful completion of pilot testing in Aim 2.

Specific Aim 2: Pilot test MBRP intervention on putative targets by randomly assigning young adults who screen for past-month alcohol use/problems to MBRP or CTL. Determine the effect of the program on secondary outcomes of interest and putative targets for ER, IMP, and EF.

Specific Aim 3: Assess MBRP mechanisms by exploring whether effects of the intervention on our substance use outcomes can be partially explained by changes in target mechanisms: ER, IMP, and EF.

Eligibility criteria: Inclusion Criteria:

* 18 to 26 years old at baseline
* English speaking
* Be willing to provide follow-up information
* Report past-month use of alcohol or drugs
* Score 2 or higher on the PC-PTSD scale
* Not currently receiving substance abuse treatment elsewhere
* Not prisoners

Exclusion Criteria:

* Does not speak English
* Receiving treatment from some other facility for substance use.
* Active psychosis symptoms

Primary outcomes:
measure: Change in Substance Use
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Change in PTSD symptoms
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Change in Depression
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Secondary outcomes:
measure: Executive Functioning
timeFrame: Baseline, 2 months post-baseline
measure: Emotion Regulation
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Impulsivity
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Delinquency
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Stress
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
measure: Violence Perpetration
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, School of Social Work
state: California
Study officials:
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