Clinical trial NCT02038231: Parenting Mindfully Study
Official title: Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Risk Behaviors
Keywords: Adolescence
Substance abuse
Mindfulness
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Inova Fairfax Hospital
First posted: 2014-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Substance Use from pre-intervention through 12 months after the intervention
timeFrame: 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
measure: Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention
timeFrame: 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 to Post-Intervention
timeFrame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
measure: Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention
timeFrame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: George Mason University Department of Psychology
state: Virginia
Study officials:
References:
citation: Chaplin TM, Mauro KL, Curby TW, Niehaus C, Fischer S, Turpyn CC, Martelli AM, Miller AB, Leichtweis RN, Baer R, Sinha R. Effects of A Parenting-Focused Mindfulness Intervention on Adolescent Substance Use and Psychopathology: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2021 Jul;49(7):861-875. doi: 10.1007/s10802-021-00782-4. Epub 2021 Feb 23.