Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

NCT07632053 | Recruiting DMC

• 1 other identifier: 4R33DA053688
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

parenting intervention; opioid use disorder; parental stress; maternal brain; evoked response potentials; brain fMRI

Outcome Measures

Primary Outcomes (10)

• Clinical trial enrollment counts.

  The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.

  3 years

• 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.

  3 years

• Electroencephalography (EEG) Brain Imaging scans counts.

  We will track the number of participants who complete EEG studies on participants before and after each arm.

  3 years

• 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.

  3 years

• Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).

  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.

  3 years

• Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).

  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.

  3 years

• Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).

  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.

  3 years

• Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).

  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.

  3 years

• Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).

  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.

  3 years

• Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).

  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.

  3 years

Study Arms (2)

Mom Power

EXPERIMENTAL

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.

Behavioral: Mom Power

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Mom Power

Interventions

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.

Also known as: Parenting Intervention

Enhanced Usual Care; Mom Power

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Mom Power is for mothers.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (10)

• Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5.

  PMID: 28936602 BACKGROUND

• Muzik M, Rosenblum KL, Alfafara EA, Schuster MM, Miller NM, Waddell RM, Stanton Kohler E. Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Arch Womens Ment Health. 2015 Jun;18(3):507-21. doi: 10.1007/s00737-014-0490-z. Epub 2015 Jan 11.

  PMID: 25577336 BACKGROUND

• Ho SS, Muzik M, Rosenblum KL, Morelen D, Nakamura Y, Swain JE. Potential Neural Mediators of Mom Power Parenting Intervention Effects on Maternal Intersubjectivity and Stress Resilience. Front Psychiatry. 2020 Dec 8;11:568824. doi: 10.3389/fpsyt.2020.568824. eCollection 2020.

  PMID: 33363481 BACKGROUND

• Swain JE, Ho SS, Rosenblum KL, Morelen D, Dayton CJ, Muzik M. Parent-child intervention decreases stress and increases maternal brain activity and connectivity during own baby-cry: An exploratory study. Dev Psychopathol. 2017 May;29(2):535-553. doi: 10.1017/S0954579417000165.

  PMID: 28401845 BACKGROUND

• Swain JE, Ho SS, Fox H, Garry D, Brummelte S. Effects of opioids on the parental brain in health and disease. Front Neuroendocrinol. 2019 Jul;54:100766. doi: 10.1016/j.yfrne.2019.100766. Epub 2019 May 22.

  PMID: 31128130 BACKGROUND

• Swain JE, Ho SS. Early postpartum resting-state functional connectivity for mothers receiving buprenorphine treatment for opioid use disorder: A pilot study. J Neuroendocrinol. 2019 Sep;31(9):e12770. doi: 10.1111/jne.12770. Epub 2019 Jul 29.

  PMID: 31287922 BACKGROUND

• Swain JE, Ho SS. Opioids and maternal brain-behavior adaptation. Neuropsychopharmacology. 2021 Jan;46(1):265-266. doi: 10.1038/s41386-020-00858-7. No abstract available.

  PMID: 32913343 BACKGROUND

• Swain JE, Ho SS. Reduced Child-Oriented Face Mirroring Brain Responses in Mothers With Opioid Use Disorder: An Exploratory Study. Front Psychol. 2022 Feb 4;12:770093. doi: 10.3389/fpsyg.2021.770093. eCollection 2021.

  PMID: 35185679 BACKGROUND

• Swain JE, Ho SS. Brain circuits for maternal sensitivity and pain involving anterior cingulate cortex among mothers receiving buprenorphine treatment for opioid use disorder. J Neuroendocrinol. 2023 Jul;35(7):e13316. doi: 10.1111/jne.13316. Epub 2023 Jul 25.

  PMID: 37491982 BACKGROUND

• Ho SS, Nakamura Y, Gopang M, Swain JE. Intersubjectivity as an antidote to stress: Using dyadic active inference model of intersubjectivity to predict the efficacy of parenting interventions in reducing stress-through the lens of dependent origination in Buddhist Madhyamaka philosophy. Front Psychol. 2022 Jul 29;13:806755. doi: 10.3389/fpsyg.2022.806755. eCollection 2022.

  PMID: 35967689 BACKGROUND

Related Links

• Home website of the Mom Power Intervention based at the University of Michigan.
• Description of related research activity at Stony Brook University.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• James E Swain, MD, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James E Swain, MD, PhD

CONTACT

516-838-7604; james.swain@stonybrookmedicine.edu

Maria Muzik, MD, MSc

CONTACT

734-846-8027

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is impossible to mask whether receiving the therapy treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: June 8, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This trial is currently anticipated to end 6/30/28. Publications addressing the primary aims will require approximately 1-3 years.
• Access Criteria: Deidentified data sets created in this research program will be made available for other qualified researchers upon request for purposes of scientific scrutiny, research or review. We will use a formal signed data-use agreement including information about the investigator's name, affiliation, address, telephone number, FAX number and e-mail address. Interested investigators will also be asked to submit their plan for analysis with the request so that the original informed consent stipulations can be honored. The cost of data retrieval and secure transfer may be requested of the investigator.

Locations

US (2)