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Parenting Mindfully Study (PM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by George Mason University
Sponsor:
Collaborators:
Inova Fairfax Hospital
Information provided by (Responsible Party):
Tara M. Chaplin, Ph.D., George Mason University
ClinicalTrials.gov Identifier:
NCT02038231
First received: January 13, 2014
Last updated: January 14, 2014
Last verified: January 2014

January 13, 2014
January 14, 2014
February 2014
July 2016   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
    Measured by a combination of self-report on the Youth Risk Behavior Survey and a drug-use intentions questionnaire and urine toxicology and alcohol breathalyzer results.
  • 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 ] [ Designated as safety issue: No ]
    Measured by self-report of onset of sex and risky sex behaviors on the Youth Risk Behavior Survey and a risky sexual behavior and intention questionnaire.
Same as current
Complete list of historical versions of study NCT02038231 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Measured by self-reported parenting behaviors on the Alabama Parenting Questionnaire and by parenting behaviors coded from videotapes of parent-adolescent interactions.
  • 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) ] [ Designated as safety issue: No ]
    Measured by adolescent's reported emotions, observed emotion expressions, and heart rate, blood pressure, and cortisol levels in response to stressful parent-adolescent interactions.
Same as current
Not Provided
Not Provided
 
Parenting Mindfully Study
Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Substance Abuse
  • HIV Risk
  • Behavioral: Parenting Mindfully Program
    see Arm Description.
  • Other: Parent Education Program
    See Arm Description.
  • Experimental: Parenting Mindfully Program
    Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks.
    Intervention: Behavioral: Parenting Mindfully Program
  • Active Comparator: Parent Education Program
    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.
    Intervention: Other: Parent Education Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
July 2019
July 2016   (final data collection date for primary outcome measure)

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.
Both
12 Years to 16 Years
Yes
United States
 
NCT02038231
8753, R34DA034823
No
Tara M. Chaplin, Ph.D., George Mason University
George Mason University
  • National Institute on Drug Abuse (NIDA)
  • Inova Fairfax Hospital
Not Provided
George Mason University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP