Parenting Mindfully Study II

Parenting Clinical Trial

Official title:

Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370768
• Other study ID #: 1770931-1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: George Mason University
• Contact: Tara Chaplin, Ph.D.
• Phone: 703-993-5309
• Email: tchaplin[@]gmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 267
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Substance Use
• Parent Stress
• Parenting
• Substance-Related Disorders

Intervention

Behavioral:
• Parenting Mindfully Intervention
Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.

Locations

Country	Name	City	State
United States	George Mason University	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
George Mason University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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