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Postpartum Intervention for Mothers With Opioid Use Disorders (PIMO)

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mom Power
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring parenting intervention, Opioid Use Disorder, parental stress, maternal brain, evoked response potentials

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 Exclusion Criteria: 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: 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.

Sites / Locations

  • University of MichiganRecruiting
  • Stony Brook UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Mom Power

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

R61 Milestone 1
To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33
R61 Milestone 2
To end with 80% of mothers in the MP condition attending >=80% of sessions
R61 Milestone 3
To end with >=70% yielding satisfactory pre- and post-intervention ERP and fMRI data
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)

Secondary Outcome Measures

Full Information

First Posted
November 5, 2022
Last Updated
May 15, 2023
Sponsor
Stony Brook University
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05614661
Brief Title
Postpartum Intervention for Mothers With Opioid Use Disorders
Acronym
PIMO
Official Title
Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
parenting intervention, Opioid Use Disorder, parental stress, maternal brain, evoked response potentials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Masking
None (Open Label)
Masking Description
-it's impossible to mask whether receiving the therapy treatment
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mom Power
Arm Type
Experimental
Arm Description
Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mom Power
Intervention Description
Experimental participants will receive virtual Mom Power via phone/internet connection. Control participants will receive mail information and confirmation phone calls.
Primary Outcome Measure Information:
Title
R61 Milestone 1
Description
To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33
Time Frame
<2 years
Title
R61 Milestone 2
Description
To end with 80% of mothers in the MP condition attending >=80% of sessions
Time Frame
<2 years
Title
R61 Milestone 3
Description
To end with >=70% yielding satisfactory pre- and post-intervention ERP and fMRI data
Time Frame
<2 years
Title
R61 Milestone 4
Description
To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P<0.05)
Time Frame
<2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mom Power for mothers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deanna Parisi, MPH
Phone
5167437710
Email
deanna.parisi@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Saum, MA, MSW
Phone
3016334402
Email
dcsaum@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Swain, MD, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Muzik, MD, MSc
Phone
734-846-8027
Email
muzik@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Diana Saum, MSW
Phone
301-633-4402
Email
dcsaum@med.umich.edu
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James E Swain, MD, PhD
Phone
516-838-7604
Email
james.swain@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Deanna Parisi, MPH
Phone
516-743-7710
Email
deanna.parisi@stonybrookmedicine.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
28936602
Citation
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.
Results Reference
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PubMed Identifier
25577336
Citation
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.
Results Reference
background
PubMed Identifier
33363481
Citation
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.
Results Reference
background
PubMed Identifier
28401845
Citation
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.
Results Reference
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Postpartum Intervention for Mothers With Opioid Use Disorders

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