NCT05537961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

August 18, 2022

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Youth Risk Behavior Surveillance System: Substance use

    alcohol, tobacco, and other drug use as measured by the Youth Risk Behavior Surveillance System. Items are measured as any use on both lifetime and past 30 days.

    change in each measure across 9 months

  • Youth Risk Behavior Surveillance System: Suicide ideation

    suicide ideation and attempts as measured by the Youth Risk Behavior Surveillance System. Suicide ideation is measured as any ideation in the past 12 months and attempts are measured as the count of attempts in the past 12 months.

    change in each measure across 9 months

  • Pediatric Patient Reported Outcomes Measurement Information System (PROMIS)

    positive affect, life satisfaction, meaning and purpose, anxiety, depressive symptoms as measured by the pediatric PROMIS. For each scale, higher scores indicate higher levels of the name of the scale. Items on each scale are summed and T scores with a mean of 50 and standard deviation of 10 are calculated.

    change in each measure across 9 months

  • Child Acceptance and Mindfulness Measure

    Mindfulness as measured by the child acceptance and mindfulness measure (CAMM). The CAMM is scored from 0 to 40 with higher scores indicating higher levels of mindfulness

    change in each measure across 9 months

  • Cognitive Emotion Regulation Questionnaire

    Positive reappraisal as measured by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ is scored from 1 to 7 with higher scores indicating higher levels of emotion regulation.

    change in each measure across 9 months

  • Nondual Awareness Dimensional Assessment

    Transcendental experiences as measured by the Nondual Awareness Dimensional Assessment (NADA). Higher scores indicate greater nondual awareness trait scored from 0 to 12 and nondual awareness states scores from 0 to 40

    change in each measure across 9 months

  • Toronto Mindfulness Scale

    Mindfulness as measured by the Toronto Mindfulness Scale. Higher scores indicate higher degree of state mindfulness. Scores range from 0 to 24 on the curiosity subscale and from 0 to 28 on the decentering subscale.

    change in each measure across 9 months

Study Arms (2)

Mindfulness

EXPERIMENTAL

Weekly mindfulness instruction embedded in classroom setting

Behavioral: Mindfulness-Oriented Recovery Enhancement

No Intervention

NO INTERVENTION

Classroom setting completed as usual

Interventions

Mindfulness instruction incorporated in classroom-based curriculum

Mindfulness

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022

You may not qualify if:

  • Not enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Christopher Cambron, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2022

First Posted

September 13, 2022

Study Start

January 13, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations