NCT05534568

The Oklahoma Parent-Child Assistance Program

Recruiting now NA Last updated 7 June 2024

What this trial tests

NA trial testing Parent-Child Assistance Program in Substance Use Disorders in 200 participants. Currently enrolling.

Timeline

15 November 2022

Primary endpoint
15 November 2025

15 November 2026

Quick facts

Lead sponsor	University of Oklahoma
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	200
Start date	15 November 2022
Primary completion	15 November 2025
Estimated completion	15 November 2026
Sites	2 locations across United States

Drugs / interventions tested

• Parent-Child Assistance Program

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →
• Pregnancy Related — all drugs for Pregnancy Related →
• Alcohol Use Disorder (AUD) — all drugs for Alcohol Use Disorder (AUD) →
• Alcohol Use Complicating Pregnancy, First Trimester — all drugs for Alcohol Use Complicating Pregnancy, First Trimester →

Sponsor

University of Oklahoma

Who can join

18 and older, female only, with Substance Use Disorders or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol for a randomized controlled trial of the Parent-Child Assistance Program: a case management and home visiting program for people using substances during pregnancy.
   Maher EJ, Stoner SA, Gerlinger J, Ferraro AC, et al · · 2024 · PMID 38627843 · DOI 10.1186/s13063-024-08098-6
2. Study Protocol for a Randomized Controlled Trial of the Parent Child Assistance Program: A Case Management and Home Visiting Program for People Using Substances During Pregnancy
   Maher EJ, Stoner SA, Gerlinger J, Ferraro AC, et al · · 2024 · DOI 10.21203/rs.3.rs-3764966/v1