Overview

This trial is active, not recruiting.

Conditions substance abuse, risk behaviors
Treatments parenting mindfully program, parent education program
Sponsor George Mason University
Collaborator National Institute on Drug Abuse (NIDA)
Start date February 2014
End date July 2017
Trial size 100 participants
Trial identifier NCT02038231, 8753, R34DA034823

Summary

The goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks.
parenting mindfully program
see Arm Description.
(Active Comparator)
Group for parents of adolescents providing handouts and brief education to parents on topics of adolescence, family relations, and risk behaviors. Group meets 3 times over the course of 8 weeks for about 15 minutes per meeting.
parent education program
See Arm Description.

Primary Outcomes

Measure
Change in Substance Use from pre-intervention through 12 months after the intervention
time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention
time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session

Secondary Outcomes

Measure
Change in Parenting from Pre-Intervention through 12 months Following the Intervention
time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention
time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)

Eligibility Criteria

Male or female participants from 12 years up to 16 years old.

Inclusion Criteria: 1. Family with a child between 12-16 years; 2. High parenting stress (mean score of >=3 on 2 questions adapted from the Perceived Stress Scale and the Parenting Stress Index). Exclusion Criteria: 1. Diagnosis of mental retardation, autism or other pervasive developmental disorder for adolescent; 2. Current serious psychiatric or medical disorder (including current substance dependence) requiring immediate treatment for adolescent or parent- We will include those that are in treatment; 3. Medical condition that would preclude participation in gentle yoga (for parents) 4. Inadequate English proficiency to complete questionnaires for youth or parents.

Additional Information

Official title Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by George Mason University.