Mindfulness-Based Substance Use Prevention (MINDS-UP)
ConditionSubstance Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorNew York State Psychiatric Institute
About this trial
The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The main questions it aims to answer are:
1. Is MINDS-UP feasible and what is its preliminary efficacy? 2. Are MRI protocol and procedures feasible?
An additional exploratory question is:
Are there neural and psychopathological mechanisms through which MINDS-UP might work?
Researchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP.
Participants will
* take assessment #1 * have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start * take assessment #2 * take PPW, a single remote and research assistant-delivered 45-minute session * take assessment #3 * take assessment #4
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Youth is ages 10-14 years on the day of screening [i.e., does not turn 15 before or on the day of screening]
Access to a smart phone, tablet, or computer with Wi-Fi
English-speaking
Disqualifiers
Has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder.
Youth is actively involved in another Boricua Youth Study (BYS)
Youth's sibling is or has previously been enrolled in MINDS-UP.
Trial design
Design model
Parallel
Treatments tested in this trial
MINDS-UP
BehavioralMINDS-UP is a substance use prevention program for children/adolescents.It consists of 4 x 60-minute sessions, once weekly over 4 weeks. The four MINDS-UP classes will focus on the following: Mindfulness of Body; Mindfulness of Mind; Mindfulness of Environment/Community; Kindness, Compassion, Joy and Equanimity, respectively.
Prevention Plus Wellness
BehavioralPPW is a standardized, empirically-based intervention for substance use prevention in adolescents ages 10-14. It consists of 1 45-60 minute session between an adolescent and a trained PPW teacher.
fMRI
Diagnostic testFunctional MRI to investigate preliminary neural mechanisms of MINDS-UP
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Sport: Prevention Plus Wellness (PPW)Active comparator 1 intervention
Group B: MINDS-UP with MRI + PPWExperimental treatment 3 interventions
Group C: MINDS-UP without MRI + PPWExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Teacher Rated Participation
Research Assessment Package for Schools - Teacher Rated
Time frame
Completion of Study (up to 36 months)2
Acceptability
Acceptability of Intervention Measure
Time frame
Completion of Study (up to 36 months)3
Retention
Percent of participants who completed all study procedures among those who were randomized
Time frame
Completion of Study (up to 36 months)4
Attendance
Percent of scheduled sessions that were completed by the participant.
Time frame
Completion of Study (up to 36 months)Secondary outcomes
1
MRI retention
Percentage of participants randomized to receive MRI that complete both MRIs
Time frame
Completion of Study (up to 36 months)2
Future MRI endorsement
Percentage of participants who endorse willingness to undergo a future research MRI scan
Time frame
Completion of Study (up to 36 months)3
Anxiety and Depression
Pre-assessment to post-assessment (and 6 and 12 month-follow-up) difference in score on the Revised Childhood Anxiety and Depression scale, a 47-item self-report scale that assesses childhood/adolescent anxiety and depression symptoms across six sub-domains.
Time frame
4-6 weeks, 6 months, and 12 months4
Mindfulness
Pre-assessment to post-assessment (and 6- and 12-month follow-up) difference in score on the Child and Adolescent Mindfulness Measure (CAMM); the CAMM is a 10-item measure of self-reported mindfulness; scores range from 0 to 40, with higher scores indicating higher mindfulness
Time frame
4-6 weeks, 6 months, and 12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: