The Oklahoma Parent-Child Assistance Program

NCT05534568 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-07

No results posted yet for this study

Summary

The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy.

This study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma.

This evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and/or with kinship providers), and (4) criminal justice involvement.

Conditions

  • Substance Use Disorders
  • Pregnancy Related
  • Alcohol Use Disorder (AUD)
  • Alcohol Use Complicating Pregnancy, First Trimester
  • Alcohol Use Complicating Pregnancy, Second Trimester
  • Alcohol Use Complicating Pregnancy, Third Trimester
  • Alcohol Use Complicating Pregnancy, Unspecified Trimester
  • Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium
  • Fetal Alcohol Spectrum Disorders
  • Fetal Alcohol Syndrome
  • Drug Use Disorders
  • Drug Use Complicating Pregnancy, First Trimester
  • Drug Use Complicating Pregnancy, Second Trimester
  • Drug Use Complicating Pregnancy, Third Trimester
  • Drug Use Complicating Pregnancy, Unspecified Trimester
  • Drug Use Complicating Pregnancy, Childbirth, and the Puerperium
  • Maternal Drugs Affecting Fetus

Interventions

OTHER

Parent-Child Assistance Program

Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources.

Sponsors & Collaborators

  • University of Oklahoma Outreach

    collaborator UNKNOWN
  • Oklahoma Mental Health and Substance Abuse

    collaborator UNKNOWN
  • Arnall Family Foundation

    collaborator UNKNOWN
  • Oklahoma Human Services

    collaborator UNKNOWN
  • OU Dodge Family College of Arts and Sciences

    collaborator UNKNOWN
  • Casey Family Programs

    collaborator UNKNOWN
  • University of Washington

    collaborator OTHER
  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Erin Maher, Ph.D. · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2025-11-15
Completion
2026-11-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534568 on ClinicalTrials.gov