Postpartum Intervention for Mothers With Opioid Use Disorders

NCT05614661 | Recruiting DMC

• 1 other identifier: IRB2022-00166
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.

Conditions

Opioid Use Disorder

Keywords

parenting intervention; Opioid Use Disorder; parental stress; maternal brain; evoked response potentials

Outcome Measures

Primary Outcomes (4)

• R61 Milestone 1

  To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33

  <2 years

• R61 Milestone 2

  To end with 80% of mothers in the MP condition attending \>=80% of sessions

  <2 years

• R61 Milestone 3

  To end with \>=70% yielding satisfactory pre- and post-intervention ERP and fMRI data

  <2 years

• R61 Milestone 4

  To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P\<0.05)

  <2 years

Study Arms (2)

Mom Power

EXPERIMENTAL

Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression

Behavioral: Mom Power

Control

SHAM 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. Control participants will receive mail information and confirmation phone calls.

Control; Mom Power

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Mom Power for mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• mothers aged 18-50 from SBU or UM 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 (please see Protection of Human Subjects section for clinical management of suicidal risk);
• For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they:

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

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

Elle Eggers, BSc

CONTACT

636-667-0135; elle.eggers@stonybrookmedicine.edu

Diana Saum, MA, MSW

CONTACT

3016334402; dcsaum@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: -it's impossible to mask whether receiving the therapy treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a 2-group (Mom Power (MP) vs. control), pre-post RCT of mothers with OUD to test the effect of MP on drug craving, mood and electrophysiological responses to own infant faces (MP n=40; control n= 10)

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: February 14, 2023
• Primary Completion: February 15, 2025
• Study Completion: May 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)