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Active Not Recruiting
NCT05370768
Parenting Mindfully Study II
Conditions: Adolescent Substance Use, Adolescent Psychological Symptoms, Parent Stress, Parenting
Sex: All
Ages: 12 Years – 14 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 269
Sponsor: George Mason University
Location: George Mason University Fairfax Virginia
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05370768). StuddyBuddy aggregates publicly available trial information.