Postpartum Intervention for Mothers With Opioid Use Disorders

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder
• Interventions: Behavioral: Mom Power

• Registration Number: NCT05614661
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Postpartum Intervention for Mothers with Opioid Use Disorders - Brain-Behavior Mechanisms Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many suffering comorbid mood disorders. Despite receiving "gold standard" buprenorphine treatment to reduce withdrawal, OUD mothers still suffer have cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. Parenting interventions have been established to improve parent mood and sensitive caregiving behaviors for high-risk non-OUD populations. "Mom Power" (MP) is an evidence-based 13-session psychosocial mother-child intervention established to enhance emotionally sensitive caregiving, while concurrently reducing parental stress and depression for non-OUD mothers. The investigators have demonstrated feasibility of with virtual MP (vMP) and for MP with substance use disorders. However, vMP for mothers with OUD has not been studied with respect to drug use reduction or mood improvement. The investigators have also established brain mechanisms that regulate parenting. Recent work from the investigators has established that a parenting intervention for non-OUD mothers was associated with a larger enhancement of evoke potential responses (ERPs) for emotional faces relative to neutral faces and that the magnitude of ERP responses to emotional faces was associated with observed maternal sensitivity. Using functional magnetic resonance imaging (fMRI) of the brain, the investigators have also established a Maternal Behavior Neurocircuit (MBN) that regulates flexible responses to the demands of their own infant - such as to the unique, ethologically salient own-baby cry and face stimuli during the early postpartum period. The investigators have established fMRI maternal brain changes associated with MP in non-OUD mothers, and brain effects of OUD on mothers. However, it is unknown how parental brain mechanisms through which parenting interventions may work for mothers with OUD, such as affecting ERP or fMRI responses to baby stimuli in the MBN. Central hypotheses: Mothers with OUD who get virtual MP (vMP), compared to matched controls, will show improved drug craving, mood, and stress symptoms, via changes in pre-specified MBN brain regions. In the high-risk R61 phase, the investigators will establish if vMP (n=25) for OUD can be implemented and improve mood, reduce drug use and affect ERP brain responses to baby pictures compared with control (n=25). If hypotheses in the R61 are confirmed, the investigators will confirm and expand this breakthrough with the R33 Phase (n=160, 80/group), adding richer maternal outcome measures and MBN fMRI. This research will elucidate the effects of parenting intervention MP on drug use and brain function for OUD mothers - with translational potential for biomarker and treatment development.

Study Timeline

• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-05
• Study First Posted: 2022-11-14
• Study Start: 2023-02-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-02-15
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

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Exclusion Criteria

1. require immediate clinical care for suicidal/homicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk);
2. 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 4) Exclusion from MRI does not necessarily exclude participant from study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
R61 Milestone 2	<2 years	To end with 80% of mothers in the MP condition attending \>=80% of sessions
R61 Milestone 4	<2 years	To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P\<0.05)
R61 Milestone 1	<2 years	To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33
R61 Milestone 3	<2 years	To end with \>=70% yielding satisfactory pre- and post-intervention ERP and fMRI data

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States