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Parenting Mindfully Study (PM)

Primary Purpose

Substance Abuse, Risk Behaviors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting Mindfully Program
Parent Education Program
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Adolescence, Substance abuse, Mindfulness

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • George Mason University Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parenting Mindfully Program

Parent Education Program

Arm Description

Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks.

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.

Outcomes

Primary Outcome Measures

Change in Substance Use from pre-intervention through 12 months after the intervention
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
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 to Post-Intervention
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
Measured by adolescent's reported emotions, observed emotion expressions, and heart rate, blood pressure, and cortisol levels in response to stressful parent-adolescent interactions.

Full Information

First Posted
January 13, 2014
Last Updated
August 6, 2019
Sponsor
George Mason University
Collaborators
National Institute on Drug Abuse (NIDA), Inova Fairfax Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02038231
Brief Title
Parenting Mindfully Study
Acronym
PM
Official Title
Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Mason University
Collaborators
National Institute on Drug Abuse (NIDA), Inova Fairfax Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Risk Behaviors
Keywords
Adolescence, Substance abuse, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parenting Mindfully Program
Arm Type
Experimental
Arm Description
Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks.
Arm Title
Parent Education Program
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Parenting Mindfully Program
Intervention Description
see Arm Description.
Intervention Type
Other
Intervention Name(s)
Parent Education Program
Intervention Description
See Arm Description.
Primary Outcome Measure Information:
Title
Change in Substance Use from pre-intervention through 12 months after the intervention
Description
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.
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
Title
Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention
Description
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.
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 Outcome Measure Information:
Title
Change in Parenting from Pre-Intervention to Post-Intervention
Description
Measured by self-reported parenting behaviors on the Alabama Parenting Questionnaire and by parenting behaviors coded from videotapes of parent-adolescent interactions.
Time Frame
Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Title
Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention
Description
Measured by adolescent's reported emotions, observed emotion expressions, and heart rate, blood pressure, and cortisol levels in response to stressful parent-adolescent interactions.
Time Frame
Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family with a child between 12-16 years; High parenting stress (mean score of >=3 on 2 questions adapted from the Perceived Stress Scale and the Parenting Stress Index). Exclusion Criteria: Diagnosis of mental retardation, autism or other pervasive developmental disorder for adolescent; 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; Medical condition that would preclude participation in gentle yoga (for parents) Inadequate English proficiency to complete questionnaires for youth or parents.
Facility Information:
Facility Name
George Mason University Department of Psychology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33620662
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.
Results Reference
derived

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Parenting Mindfully Study

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