Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05537961 |
| Other study ID # |
IRB_00122449 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2022 |
| Est. completion date |
May 15, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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. The
investigators 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. The investigators 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). The
investigators 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.
