NCT04160754

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

Completed NA Last updated 29 September 2021

What this trial tests

NA trial testing Mindfulness Based Relapse Prevention in Alcohol Use, Underage in 24 participants. Completed in 30 June 2020.

Timeline

5 March 2019

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	5 March 2019
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness Based Relapse Prevention
• Control (CTL)

Conditions studied

• Alcohol Use, Underage — all drugs for Alcohol Use, Underage →
• Alcohol Problem Drinking — all drugs for Alcohol Problem Drinking →
• Substance Use — all drugs for Substance Use →

Sponsor

University of Southern California

Who can join

Adults 18 to 26, any sex, with Alcohol Use, Underage or Alcohol Problem Drinking. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mindfulness-based interventions for substance use disorders.
   Goldberg SB, Pace B, Griskaitis M, Willutzki R, et al · · 2021 · cited 21× · PMID 34668188 · DOI 10.1002/14651858.cd011723.pub2