Parenting Mindfully Study II

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adolescent Substance Use, Adolescent Psychological Symptoms, Parent Stress, Parenting

Intervention / Treatment
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* Behavioral: Parenting Mindfully Intervention


Participation Criteria
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Eligibility Criteria
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Main Study Inclusion/Exclusion Criteria: Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Mindfully (PM) Intervention<br>PM is an group based 8 week mindfulness intervention for parents. | Behavioral: Parenting Mindfully Intervention<br>* Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.<br>|
| Active Comparator: Parent Education (PE) Intervention<br>PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development. | Behavioral: Parenting Mindfully Intervention<br>* Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 2 years |