George Mason University
Fairfax, Virginia, 22030, United States
NCT Number: NCT05370768
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.
This study is active but is not currently recruiting participants.
12 year–14 year
All sexes
Interventional
Not applicable
Fairfax, Virginia, 22030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Main Study Inclusion/Exclusion Criteria:
Inclusion criteria
Exclusion criteria
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.
Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.
Time frame: 2 years
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. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Time frame: 2 years
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. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
George Mason University
Other
Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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