Parenting Mindfully Study II

Not Applicable

Active, not recruiting

• Conditions: Adolescent Psychological Symptoms; Parent Stress; Parenting; Adolescent Substance Use
• Interventions: Behavioral: Parenting Mindfully Intervention

• Registration Number: NCT05370768
• Lead Sponsor: George Mason University

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 269

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenting Mindfully (PM) Intervention	Parenting Mindfully Intervention	PM is an group based 8 week mindfulness intervention for parents.
Parent Education (PE) Intervention	Parenting Mindfully Intervention	PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.

Primary Outcome Measures

Name	Time	Method
Adolescent substance use	2 years	frequency and amount of substance use This will be based on combining (in a composite score) information from the Youth Risk Behavior Survey, Urine and Breath Screens, and the Timeline Follow Back Interview to determine frequency and amount of use. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Adolescent psychological symptoms	2 years	youth self reported symptoms on the Youth Inventory and parent reported symptoms on the Child Symptom Inventory will be combined or, if needed, tested separately in analyses. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).

Trial Locations

Locations (1)

George Mason University; 🇺🇸 Fairfax, Virginia, United States