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Completed

NCT Number: NCT02038231

Parenting Mindfully Study

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.

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Key information

Conditions

Substance Abuse Behavior Chemically-Induced Disorders Mental Disorders Risk Behaviors Risk-Taking Substance-Related Disorders

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Mason University Department of Psychology

Fairfax, Virginia, 22030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenting Mindfully Program

Behavioral

see Arm Description.

Parent Education Program

Other

See Arm Description.

Primary outcomes

  1. 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

    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.

  2. 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

    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 outcomes

  1. Change in Parenting from Pre-Intervention to Post-Intervention

    Time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)

    Measured by self-reported parenting behaviors on the Alabama Parenting Questionnaire and by parenting behaviors coded from videotapes of parent-adolescent interactions.

  2. 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)

    Measured by adolescent's reported emotions, observed emotion expressions, and heart rate, blood pressure, and cortisol levels in response to stressful parent-adolescent interactions.

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Collaborators

  • Inova Fairfax Hospital
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PM

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jan 16, 2014
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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