Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorStony Brook University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Mom Power
BehavioralExperimental participants will receive virtual Mom Power via phone/internet connection. Mom Power (MP), rooted in attachment theory and trauma-informed clinical work is an evidence-based, manualized, 13-session (10 group + 3 individual) intervention delivered across 12-weeks. The manualized intervention rests on five core components paralleling the Strengthening Families/Protective Factors Framework: Parenting Education; Self-Care; Guided Parent-Child Interactions; Social Support; and Connection to Resources. MP targets reflective function as a critical parental capacity to infer benevolent and developmentally appropriate meaning underlying a child's behavior during stressful parenting moments, and thus promote each parents' own emotion regulation during such moments. In addition, MP counteracts social isolation by capitalizing on peer group structure with facilitated group activities and tight case management.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Mom PowerExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical trial enrollment counts.
The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
Time frame
3 years2
Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Mom Power (MP) and Enhanced Usual Care will be administered to as many participants as possible. For MP, participants receive a manualized, 12-week group therapy. For EUC, mothers will recieve 12 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), but void of specific MP-related parenting concepts. Additionally, control mothers receive 12 brief check-in calls verifying that material was received.
Time frame
3 years3
Electroencephalography (EEG) Brain Imaging scans counts.
We will track the number of participants who complete EEG studies on participants before and after each arm.
Time frame
3 years4
Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
We will track fMRI studies on participants before and after each arm.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stony Brook University
Lead sponsor
University of Michigan
Collaborator
Source ClinicalTrials.gov