Parenting Mindfully Study II

Last updated: April 7, 2025
Sponsor: George Mason University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Stimulant Use Disorder

Treatment

Parenting Mindfully Intervention

Clinical Study ID

NCT05370768
1770931-1
  • Ages 12-14
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

Main

Exclusion

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 stressscreener;

  3. Adequate English proficiency to complete questionnaires for adolescent and at leastone parent (because several of our questionnaires have not been validated for use inother 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 referparticipants with active suicidality for inpatient treatment. They will be eligibleto participate in the study once stabilized),

  3. Current SUDs that are untreated for parent except Tobacco Use Disorder (becauseparticipants must to be able to refrain from substances except nicotine/tobaccoduring the PAIT lab session day safely without withdrawal symptoms). We will referparents with active SUDs to treatment. They will be eligible to participate in thestudy 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.

Study Design

Total Participants: 269
Treatment Group(s): 1
Primary Treatment: Parenting Mindfully Intervention
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • George Mason University

    Fairfax, Virginia 22030
    United States

    Site Not Available

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