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NCT07632053

Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

Recruiting
NAAges 18–50InterventionalTreatment
Stony Brook University
~80 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Mom Power

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical trial enrollment counts.
Measured over 3 years
+9 more outcomes measured

Conditions

Opioid Use Disorder
Parent-Child Relations

Explore related trials

Opioid Use Disorder

Where it's being run

2 sites across 2 states
Michigan1
New York1

Study leadership

  • James E Swain, MD, PhD · PRINCIPAL_INVESTIGATOR · Stony Brook University

Who to contact

James E Swain, MD, PhD
[email protected]
516-838-7604
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Clinical trial enrollment counts.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.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.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.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).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).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).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).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).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).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.