Parenting Mindfully Study II

George Mason University (GMU)

Status: Active, not recruiting

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

Treatments: Behavioral: Parenting Mindfully Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05370768

1770931-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 269 patients

Sex: All

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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269 participants in 2 patient groups

Parenting Mindfully (PM) Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Parenting Mindfully Intervention

Parent Education (PE) Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Parenting Mindfully Intervention