CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Mindfulness Based Relapse Prevention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04160754
NCT04160754N/ACompleted

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

University of Southern California·interventional·Posted Nov 13, 2019·Updated Sep 29, 2021

In Brief

A clinical study evaluating Mindfulness Based Relapse Prevention and Control (CTL) for Alcohol Use, Underage and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2019
Enrollment StartMar 5, 2019
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago

Interventions

Mindfulness Based Relapse Preventionbehavioral

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.

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