Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
Purpose
Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.
Conditions
- Opioid Use Disorder
- Parent-Child Relations
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- mothers 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
- require immediate clinical care for suicidal/homicidal risk or psychosis; - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- This is a 2-site, 2-group, pre-post randomized controlled trial (RCT) of mothers with OUD (up n=80/group). We will extend the R61 findings by testing whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers randomized to the control group of enhanced usual care (EUC).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- It is impossible to mask whether receiving the therapy treatment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mom Power |
Mom Power (MP) is an evidence-based 13-session (1/week delivered virtually) psychosocial mother-child intervention with two experienced therapist facilitators that improves sensitive caregiving, parental stress, and depression. |
|
|
Active Comparator Enhanced Usual Care |
Controls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed/requested. |
|
Recruiting Locations
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Stony Brook University
Stony Brook, New York 11794
Stony Brook, New York 11794
More Details
- Status
- Recruiting
- Sponsor
- Stony Brook University
Detailed Description
Informed by the results from the R61 phase, we have fine-tuned the exact hypotheses as follows: Post-intervention, mothers with OUD randomized to receive MP, compared to control group of enhanced usual care (EUC), will exhibit Hypothesis (a) - lower Evoked Response Potential (ERP) responses to infant's crying and Hypothesis (b) - normalized fMRI-assessed brain activity in key MBN regions, e.g., hypothalamus, amygdala and periaqueductal gray. Hypothesis (c) The pre-to-post improvements in mothers' drug craving, mood and parental stress will be greater for mothers in the vMP vs. EUC conditions. Hypothesis (d) Assuming Ha-c are confirmed, we will test whether the clinical benefits of vMP are mediated through vMP-induced changes in the MBN.