Parenting intervention for mothers with opioid use disorder
Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms
This study is testing a parenting program called 'Mom Power' to see if it can help mothers with opioid use disorder improve their drug use, mood, and parenting skills in the first six months after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Stony Brook University Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT05614661 on ClinicalTrials.gov |
What this trial studies
This project focuses on mothers suffering from opioid use disorder (OUD) and aims to implement the 'Mom Power' parenting intervention during the first six months postpartum. The intervention seeks to improve drug use, mood, and parenting behaviors while also investigating brain mechanisms associated with these changes. The study will begin with a high-risk phase to assess feasibility and effectiveness, followed by a larger phase if initial results are promising. The ultimate goal is to identify brain-based biomarkers that could enhance treatment for families affected by OUD.
Who should consider this trial
Good fit: Ideal candidates are mothers aged 18-50 diagnosed with opioid use disorder and/or receiving medication-assisted treatment, who have a child aged 5 or younger.
Not a fit: Patients requiring immediate clinical care for suicidal or homicidal risk, or those with severe neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and parenting capabilities of mothers with OUD, benefiting both them and their children.
How similar studies have performed: Previous studies have shown success with parenting interventions for non-OUD populations, but this specific approach for mothers with OUD is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * mothers aged 18-50 from SBU or UM with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone) * with a child aged 5 or less * able to read, hear and understand English adequately enough to provide informed consent Exclusion Criteria: 1. require immediate clinical care for suicidal/homicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk); 2. For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: 1\) have ferromagnetic metal in their heads 2) have severe claustrophobia that prevents participation in the neuroimaging 3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma 4) Exclusion from MRI does not necessarily exclude participant from study.
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Stony Brook University — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: James E Swain, MD, PhD — Stony Brook University
- Study coordinator: Elle Eggers, BSc
- Email: elle.eggers@stonybrookmedicine.edu
- Phone: 636-667-0135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.