Parenting Mindfully Study II

N/AActive Not RecruitingNCT05370768

George Mason University269 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

269

Conditions

Adolescent Substance Use Adolescent Psychological Symptoms Parent Stress Parenting

Interventions

Parenting Mindfully InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main Study Inclusion/Exclusion 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.

Locations (1)

George Mason University

Fairfax, Virginia, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 2 years

Data from ClinicalTrials.gov

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