RECRUITING

Postpartum Intervention for Mothers With Opioid Use Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms

Quick Facts

Study Start:2023-02-14
Study Completion:2024-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05614661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * with a child aged 5 or less
  3. * able to read, hear and understand English adequately enough to provide informed consent
  1. 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. 2. For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they:

Contacts and Locations

Study Contact

Deanna Parisi, MPH
CONTACT
5167437710
deanna.parisi@stonybrookmedicine.edu
Diana Saum, MA, MSW
CONTACT
3016334402
dcsaum@med.umich.edu

Principal Investigator

James E Swain, MD, PhD
PRINCIPAL_INVESTIGATOR
Stony Brook University

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
Stony Brook University
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Stony Brook University

  • James E Swain, MD, PhD, PRINCIPAL_INVESTIGATOR, Stony Brook University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14
Study Completion Date2024-06-30

Study Record Updates

Study Start Date2023-02-14
Study Completion Date2024-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Opioid Use Disorder