Parenting Mindfully Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Abuse, Risk Behaviors

Intervention / Treatment
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* Behavioral: Parenting Mindfully Program
* Other: Parent Education Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Mindfully Program<br>Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks. | Behavioral: Parenting Mindfully Program<br>* see Arm Description.<br>|
| Active Comparator: Parent Education Program<br>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<br>* See Arm Description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescence, Substance abuse, Mindfulness