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NCT Number: NCT07632053

Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Parent-Child Relations Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mom Power

Behavioral

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.

Other names: Parenting Intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

James E Swain, MD, PhD

CONTACT

[email protected]

516-838-7604

Maria Muzik, MD, MSc

CONTACT

734-846-8027

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • University of Michigan

Registry information

Acronym: PIMO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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