Back to resultsParenting Mindfully Study II
Primary Purpose
Adolescent Substance Use, Adolescent Psychological Symptoms, Parent Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting Mindfully Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Adolescent Substance Use
Eligibility Criteria
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.
Sites / Locations
- George Mason UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parenting Mindfully (PM) Intervention
Parent Education (PE) Intervention
Arm Description
PM is an group based 8 week mindfulness intervention for parents.
PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05370768
Brief Title
Parenting Mindfully Study II
Official Title
Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Mason University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Use, Adolescent Psychological Symptoms, Parent Stress, Parenting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
267 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parenting Mindfully (PM) Intervention
Arm Type
Experimental
Arm Description
PM is an group based 8 week mindfulness intervention for parents.
Arm Title
Parent Education (PE) Intervention
Arm Type
Active Comparator
Arm Description
PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.
Intervention Type
Behavioral
Intervention Name(s)
Parenting Mindfully Intervention
Intervention Description
Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.
Primary Outcome Measure Information:
Title
Adolescent substance use
Description
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
Time Frame
2 years
Title
Adolescent psychological symptoms
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Chaplin, Ph.D.
Phone
703-993-5309
Email
tchaplin@gmu.edu
Facility Information:
Facility Name
George Mason University
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Chaplin, Ph.D.
Phone
703-993-5309
Email
tchaplin@gmu.edu
First Name & Middle Initial & Last Name & Degree
Tara Chaplin, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Parenting Mindfully Study II
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