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
  Purpose

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.


Condition Intervention
Substance Abuse
HIV Risk
Behavioral: Parenting Mindfully Program
Other: Parent Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use

Resource links provided by NLM:


Further study details as provided by George Mason University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: February 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parenting Mindfully Program
Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks.
Behavioral: Parenting Mindfully Program
see Arm Description.
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.
Other: Parent Education Program
See Arm Description.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038231

Locations
United States, Virginia
George Mason University Department of Psychology Not yet recruiting
Fairfax, Virginia, United States, 22030
Contact: Tara Chaplin, Ph.D.    703-993-5066    tchaplin@gmu.edu   
Contact: Ali Martelli, BA    703-993-5066    amartel2@gmu.edu   
Principal Investigator: Tara M Chaplin, Ph.D.         
Inova Kellar Center Not yet recruiting
Fairfax, Virginia, United States, 22030
Contact: Adam Miller, B.A.    703-218-8553    Adam.Miller@inova.org   
Principal Investigator: Adam B Miller, MA         
Sub-Investigator: Tara M Chaplin, Ph.D.         
Sponsors and Collaborators
George Mason University
Inova Fairfax Hospital
  More Information

No publications provided

Responsible Party: Tara M. Chaplin, Ph.D., Assistant Professor of Psychology, George Mason University
ClinicalTrials.gov Identifier: NCT02038231     History of Changes
Other Study ID Numbers: 8753, R34DA034823
Study First Received: January 13, 2014
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by George Mason University:
Adolescence
Substance abuse
Mindfulness

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014