NCT02038231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

January 13, 2014

Last Update Submit

August 6, 2019

Conditions

Substance AbuseRisk Behaviors

Keywords

AdolescenceSubstance abuseMindfulness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in Parenting from Pre-Intervention to Post-Intervention

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

  • Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention

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

Study Arms (2)

Parenting Mindfully Program

EXPERIMENTAL

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

Behavioral: Parenting Mindfully Program

Parent Education Program

ACTIVE COMPARATOR

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

Interventions

Parenting Mindfully ProgramBEHAVIORAL

see Arm Description.

Parenting Mindfully Program
Parent Education ProgramOTHER

See Arm Description.

Parent Education Program

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mason University Department of Psychology

Fairfax, Virginia, 22030, United States

Location

Related Publications (1)

  • 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.

    PMID: 33620662DERIVED

MeSH Terms

Conditions

Substance-Related DisordersRisk-Taking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 16, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2018

Study Completion

July 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

US(1)