Parenting Mindfully Study II

NCT ID: NCT05370768

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2027-05-31

Brief Summary

This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents.

Detailed Description

Parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week PM or PE intervention. Before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. At pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. Some mothers will also complete fMRI sessions at pre- and post- examining emotion-related neurobiological mechanisms.

Conditions

Adolescent Substance Use; Adolescent Psychological Symptoms; Parent Stress; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Parenting Mindfully (PM) Intervention

PM is an group based 8 week mindfulness intervention for parents.

Group Type: EXPERIMENTAL

Parenting Mindfully Intervention

Intervention Type: BEHAVIORAL

Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.

Parent Education (PE) Intervention

PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.

Group Type: ACTIVE_COMPARATOR

Parenting Mindfully Intervention

Intervention Type: BEHAVIORAL

Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.

Interventions

Parenting Mindfully Intervention

Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Family with adolescent between 12-14 years;

2. High stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener;

3. Adequate English proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages)

Exclusion Criteria

1. Diagnosis of intellectual disability for adolescent or psychosis for adolescent;

2. Current active suicidality that is untreated for parent or adolescent (We will refer participants with active suicidality for inpatient treatment. They will be eligible to participate in the study once stabilized),

3. Current SUDs that are untreated for parent except Tobacco Use Disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the PAIT lab session day safely without withdrawal symptoms). We will refer parents with active SUDs to treatment. They will be eligible to participate in the study once stabilized and in treatment.

4. Lifetime SUD diagnosis for adolescent because an aim of the study is SUD prevention.

Note: We are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fMRI) scans are pre and post-intervention. If we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fMRI.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Mason University

OTHER

Sponsor Role: lead

Responsible Party

Tara M. Chaplin, Ph.D.

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

George Mason University

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

1770931-1

Identifier Type: -

Identifier Source: org_study_id