Parenting Mindfully Study

Substance Abuse Clinical Trial

— PM  

Official title:

Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038231
• Other study ID #: 8753
• Secondary ID: R34DA034823
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: George Mason University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Risk Behaviors
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Parenting Mindfully Program
see Arm Description.

Other:
• Parent Education Program
See Arm Description.

Locations

Country	Name	City	State
United States	George Mason University Department of Psychology	Fairfax	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
George Mason University	Inova Fairfax Hospital, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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	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.	Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Secondary	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.	Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)