NCT07632053 · Stony Brook University
Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
(PIMO)
What this study is about
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 randomly assigned to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.
View original scientific description
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.
Interventions
BEHAVIORAL
Mom Power
Experimental 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.
Primary outcome measures
Clinical trial enrollment counts.
Time frame: 3 years
The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Time frame: 3 years
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.
Electroencephalography (EEG) Brain Imaging scans counts.
Time frame: 3 years
We will track the number of participants who complete EEG studies on participants before and after each arm.
Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
Time frame: 3 years
We will track fMRI studies on participants before and after each arm.
Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on mood, using the Edinburgh Postnatal Depression Scale (EPDS). This is a 10-item scale with scores range from 0-30, with higher scores indicating more severe depressive symptoms.
Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on anxiety with the PTSD Checklist for DSM-5 (PCL-5). This is a 20-item scale ranging from 0-80, with higher scores indicating greater PTSD symptom severity.
Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on parenting stress using the Parenting Stress Index (PSI). The PSI is a 36-item questionnaire with scores ranging from 0-12 for three subscales: parental distress, parent-child interactions, and perceptions of child behaviors. Greater scores indicate greater parenting-related stress.
Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on drug craving using the Opioid Craving Scale (OCS). This is a 3-item scale. Higher scores indicate greater opioid craving severity, frequency of cravings, and perceived likelihood of opioid use in response to personal triggers.
Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on EEG response potentials evoked by infant stimuli.
Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on the brain, with measures of Blood Oxygenation Level Dependent fMRI signals in response to own infant pictures in the amygdala, hypothalamus and periaqueductal gray.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
- Stony Brook, New York
Collaborators
University of Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations