Impact of Mindfulness Training on Adolescent Well-Being and Behavior

Sponsor
University of Utah (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05537961
Collaborator
(none)
80
1
2
16
5

Study Details

Study Description

Brief Summary

There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.

The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Oriented Recovery Enhancement
N/A

Detailed Description

There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.

The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up. Trajectories of change will be assessed to test the following three aims.

Aim 1 is to examine the impact of MORE on changes in students' psychological well-being (i.e., anxiety, depression, stress) and ATOD use relative to a standard curriculum. We hypothesize that MORE will improve psychological well-being and reduce ATOD use, relative to the standard curriculum.

Aim 2 is to examine the impact of MORE on changes in students' attentional control (i.e., mindfulness), negative emotion regulation (i.e., positive reappraisal), positive emotion generation (i.e., savoring), and feelings of connectedness (i.e., self-transcendence) relative to a standard curriculum. We hypothesize that MORE will improve attentional control, negative emotion regulation, and positive emotion generation, as well as increasing feelings of connectedness, relative to a standard curriculum.

Aim 3 is to examine the extent to which MORE encourages improved psychological well-being and reduced ATOD use via the therapeutic mechanisms identified in Aim 2 (attentional control, negative emotion regulation, positive emotion generation, and feelings of connectedness). We hypothesize that the relationship between MORE and positive outcomes will be mediated by the proposed therapeutic mechanisms.

Hypothesis: Results of the current study will provide important information to advance the fields of both ATOD prevention and school-based MBIs. Additionally, results of this study will be of wide interest to school administrators, school counselors, and clinicians working to prevent adolescent substance use. Successful completion of this study will lead to multiple publications. Additionally, results of this study will provide essential pilot data to inform further testing of MORE for adolescents via randomized controlled trials and support multiple possible grant submissions. While MBIs have become a common part of substance abuse treatment among adults, school-based MBIs for ATOD prevention lack sufficient evidence and are yet to be regularly incorporated into standard prevention efforts.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Mindfulness Training on Adolescent Well-Being and Behavior
Actual Study Start Date :
Jan 13, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness

Weekly mindfulness instruction embedded in classroom setting

Behavioral: Mindfulness-Oriented Recovery Enhancement
Mindfulness instruction incorporated in classroom-based curriculum

No Intervention: No Intervention

Classroom setting completed as usual

Outcome Measures

Primary Outcome Measures

  1. Youth Risk Behavior Surveillance System: Substance use [change in each measure across 9 months]

    alcohol, tobacco, and other drug use as measured by the Youth Risk Behavior Surveillance System

  2. Youth Risk Behavior Surveillance System: Suicide ideation [change in each measure across 9 months]

    suicide ideation and attempts as measured by the Youth Risk Behavior Surveillance System

  3. Pediatric PROMIS scale [change in each measure across 9 months]

    positive affect, life satisfaction, meaning and purpose, anxiety, depressive symptoms as measured by the pediatric PROMIS

  4. Child Acceptance and Mindfulness Measure [change in each measure across 9 months]

    Mindfulness as measured by the child acceptance and mindfulness measure (CAMM)

  5. Cognitive Emotion Regulation Questionnaire [change in each measure across 9 months]

    Positive reappraisal as measured by the Cognitive Emotion Regulation Questionnaire (CERQ)

  6. Nondual Awareness Dimensional Assessment [change in each measure across 9 months]

    Transcendental experiences as measured by the Nondual Awareness Dimensional Assessment (NADA)

  7. Toronto Mindfulness Scale [change in each measure across 9 months]

    Mindfulness as measured by the Toronto Mindfulness Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022
Exclusion Criteria:
  • Not enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah Salt Lake City Utah United States 84112

Sponsors and Collaborators

  • University of Utah

Investigators

  • Principal Investigator: Christopher Cambron, PhD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Cambron, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT05537961
Other Study ID Numbers:
  • IRB_00122449
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2022