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NCT05534568 · ClinicalTrials.gov registry record · NA

The Oklahoma Parent-Child Assistance Program

A NA study of Pregnancy Related and Substance Use Disorders, sponsored by University of Oklahoma.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
2
Study locations

NCT05534568: Recruiting NA study of Pregnancy Related and Substance Use Disorders, sponsored by University of Oklahoma.

NCT05534568 is a NA study of Pregnancy Related and Substance Use Disorders that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 200 participants, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05534568, a NA study of Pregnancy Related and Substance Use Disorders, is actively recruiting participants, sponsored by University of Oklahoma.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
2
Study locations

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.

Primary Outcome

The mother is on a reliable method(s) of birth control.

Interventions

  • OTHER Parent-Child Assistance Program

Study Locations (2)

Oklahoma

  • Oklahoma City - Oklahoma City
  • Tulsa - Tulsa

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2022-11-15
Est. Completion 2026-11-15
Phase NA
University of Oklahoma

358 total trials

What NCT05534568 shows while recruiting

NCT05534568 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower).

The record links to 10 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which Parent-Child Assistance Program is the first listed.

NCT05534568 reports a single indexed study location in Oklahoma.

Frequently Asked Questions

What is clinical trial NCT05534568 about?

NCT05534568 is a clinical study titled "The Oklahoma Parent-Child Assistance Program". 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 mother...

What is the current status of trial NCT05534568?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2022-11-15. Estimated completion is 2026-11-15.

What conditions does trial NCT05534568 study?

This clinical trial studies the following conditions: Pregnancy Related, Substance Use Disorders, Alcohol Use Disorder (AUD), Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome.

What interventions are being tested in trial NCT05534568?

The interventions under investigation include: Parent-Child Assistance Program (OTHER).

Who is sponsoring clinical trial NCT05534568?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05534568 being conducted?

This trial has 2 study locations across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pregnancy Related

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05534568's enrollment target sits among peer trials

200 44th of 99 higher than 55 of 99 other Pregnancy Related trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05534568, the US trial registry maintained by the National Library of Medicine. NCT05534568 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.