Postpartum Intervention for Mothers With Opioid Use Disorders

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Stony Brook University
Study ID
NCT05614661
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Feb 14, 2023
Status verified
Dec 2024
Primary completion
Feb 15, 2025
Completion
May 1, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mom Power
    Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression
  • Sham Comparator: Control
    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.

Primary Outcome Measure

R61 Milestone 1 [ Time Frame: <2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Maria Muzik, MD, MSc
[email protected]
734-846-8027
Diana Saum, MSW
[email protected]
301-633-4402
Stony Brook UniversityStony BrookNew York11794
James E Swain, MD, PhD
[email protected]
516-838-7604
Elle Eggers, BSc
[email protected]
636-667-0135

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MIStony Brook University· Stony Brook, NY

Related Studies