Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change

NCT04160754 | Completed

• 1 other identifier: up-18-00230
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Underage; Alcohol Problem Drinking; Substance Use

Keywords

Trauma; Delinquency; Substance Use; Emotion Regulation; Impulsivity; Executive Functioning

Outcome Measures

Primary Outcomes (3)

• Change in Substance Use

  Substance use will be measured using time line follow back approach for 15 different substances. We will ask about days of use and number of times used for each substance in the past month

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

• Change in PTSD symptoms

  Initial screening of PTSD symptoms will be assessed by the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). We will further assess PTSD symptoms using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of PTSD.

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

• Change in Depression

  Depression will be measured with the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D includes 20 items instructing participants how often they have experienced a variety of symptoms in the past week, ranging from "rarely or none of the time" to "Most or all of the time." The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomology.

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

Secondary Outcomes (6)

• Executive Functioning

  Baseline, 2 months post-baseline

• Emotion Regulation

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

• Impulsivity

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

• Delinquency

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

• Stress

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months

Study Arms (2)

MBRP

EXPERIMENTAL

The experimental group will receive treatment as usual plus eight Mindfulness based relapse prevention (MBRP) therapy sessions.

Behavioral: Mindfulness Based Relapse Prevention

Control (CTL)

ACTIVE COMPARATOR

The CTL group will receive treatment as usual plus information on the neurobiology of addiction and healthy behaviors.

Behavioral: Control (CTL)

Interventions

Mindfulness Based Relapse Prevention BEHAVIORAL

Individuals assigned to the experimental group will receive interventions normally provided at the clinic and eight 1.5-hour group sessions of MBRP. Each sessions will occur once per week and 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. Each session will incorporate a mindfulness meditation technique (e.g.,SOBER breathing space and "urge surfing"). Participants will receive materials (e.g., recordings) with which to perform practices and meditation during the intervention phase.

MBRP

Control (CTL) BEHAVIORAL

Individuals assigned to the CTL group will receive interventions provided at the clinic and up to eight CTL sessions. The CTL group will receive information (reading) and videos once per week on health behaviors (e.g., exercise, eating) and the neurobiology of addiction. This approach will reduce the possibility that intervention effects are solely due to the experimental group's receiving extra attention. In contrast to the active intervention, sessions will be educational in nature, with no motivational, cognitive, or behavioral components

Control (CTL)

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California, School of Social Work

Los Angeles, California, 90089, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Underage Drinking; Alcoholism; Substance-Related Disorders; Wounds and Injuries; Emotional Regulation; Impulsive Behavior

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 13, 2019
• Study Start: March 5, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

US (1)