Parenting Mindfully Study II

NCT05370768 | Active Not Recruiting

• 1 other identifier: 1770931-1
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Adolescent substance use

  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).

  2 years

• Adolescent psychological symptoms

  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).

  2 years

Study Arms (2)

Parenting Mindfully (PM) Intervention

EXPERIMENTAL

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

Behavioral: Parenting Mindfully Intervention

Parent Education (PE) Intervention

ACTIVE COMPARATOR

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

Behavioral: Parenting Mindfully Intervention

Interventions

Parenting Mindfully Intervention BEHAVIORAL

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

Parent Education (PE) Intervention; Parenting Mindfully (PM) Intervention

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Family with adolescent between 12-14 years;
• 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;
• 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)
• Diagnosis of intellectual disability for adolescent or psychosis for adolescent;
• 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),
• 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.
• 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.

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 12, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)