CClinicalTrials.gg
RecruitingNCT05534568Updated Jun 7, 2024

The Oklahoma Parent-Child Assistance Program

An interventional study of Parent-Child Assistance Program in Substance Use Disorders, Pregnancy Related and Alcohol Use Disorder (AUD), sponsored by University of Oklahoma. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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.

Read the detailed 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. In Washington state, where PCAP was first developed and implemented by researchers at the University of Washington in 1991 with federal funding, PCAP has expanded to 15 sites, covering 19 counties and a large majority of the state's population. The population the Washington program serves is highly vulnerable with significant childhood trauma. Eighty-nine percent of the mothers themselves had parents who abused alcohol and drugs. Nearly two-thirds were physically or sexually abused as children. Approximately one quarter had spent time in foster care. Thirty-five percent did not have a high school degree. Among 36% of mothers, Temporary Assistance for Needy Families (TANF) was their main source of income. The investigators anticipate that PCAP participants in Oklahoma will share similar characteristics with those in Washington.

PCAP in Washington conducts evaluations focused on tracking outcomes for all participants. Despite the complex needs and vulnerability of this population and the tenuous situation of substance abuse while pregnant, PCAP outcomes are impressive. Among 1,561 graduates of the 3-year program between 2014-2020, at their exit from the program:

  • 90% had completed SUD treatment or were in progress
  • 82% were abstinent from alcohol and drugs for 6 months or more during the program and/or regularly using reliable contraception
  • 54% had attended or completed classes (GED, college, or work training)
  • 70% of the mothers had retained or regained legal custody of their child
  • 93% had obtained well child visits and were up to date on child immunizations

Graduates of Washington PCAP were also less likely to use illicit drugs and receive TANF and more likely to be employed, use reliable contraceptives, and reside in permanent or stable housing. Furthermore, the Washington State legislature, prior to expanding the program, requested a cost savings analysis. This analysis, based on robust evaluation results, shows that the program likely realizes multiple sources of cost savings from reduced dependence on child welfare, fewer subsequent alcohol- and drug-exposed children, and reduced dependence on public assistance, among other benefits. The investigators expect similar outcomes for PCAP in Oklahoma.

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. The control group will be provided with a service resource list and receive services as usual but will not be enrolled in PCAP. The intervention will conclude with sufficient time for a six-month follow-up survey for women who are among the first to enroll in PCAP.

The evaluation of Oklahoma PCAP includes multiple surveys to 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. 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.

02

Conditions studied

  • 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

Keywords

  • Parent-child assistance
  • Substance use disorder
  • addictions
  • drug dependence
  • drug abuse
  • alcohol dependence
  • alcohol abuse
  • alcoholism
  • recovery services
  • PCAP
03

In context

Fetal Alcohol Spectrum Disorders

63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.

Browse Fetal Alcohol Spectrum Disorders studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years or older
  • Women who have used alcohol, opioids, or other drugs during pregnancy
  • Women who are (1) pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or (2) have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years
  • Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma

Exclusion criteria

Exclusion Criteria:

  • Not meeting eligible criteria above
  • Incarcerated at the time of enrollment
  • Enrollment in similar services (i.e., ReMerge, Systems of Care (SOC) and/or Family Treatment Courts (FTC) and heading to Termination of Parental Rights (TPR))
  • If the participant is receiving services from the Substance use Treatment and Recovery (STAR) Prenatal Clinic and is part of the research, their enrollment in PCAP will be delayed until STAR Prenatal Clinic graduation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    The treatment group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Mothers who are randomly assigned to the treatment group will receive PCAP services through the work of highly trained, closely supervised case managers.

    Other: Parent-Child Assistance Program

  • No intervention
    Control Group

    The control group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Women in the control group will be provided with a service resource list and receive services as usual, but they will not be enrolled in PCAP.

Interventions

  • OtherParent-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.

06

What researchers measure

Primary outcomes

  1. Change in using a reliable method(s) of birth control

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

    Time frame: Measured every six months up to 4 years

  2. Change in abstinence

    The mother is abstinent from alcohol and drugs for at least six months.

    Time frame: Measured every six months up to 4 years

Secondary outcomes

  1. Change in criminal justice involvement

    The mother has had no new involvement with the criminal justice system.

    Time frame: Measured every six months up to 4 years

  2. Change in child custody

    The mother has physical custody of the index child.

    Time frame: Measured every six months up to 4 years

  3. Change in stable housing

    The mother resides in stable housing.

    Time frame: Measured every six months up to 4 years

  4. Change in employment

    The mother is employed.

    Time frame: Measured every six months up to 4 years

  5. Change in education

    The mother has completed or is enrolled in educational program.

    Time frame: Measured every six months up to 4 years

  6. Change in use of public benefits

    The mother receives public benefits (e.g., housing, food, cash)

    Time frame: Measured every six months up to 4 years

07

Study locations

2 of 2 sites recruiting
  • Oklahoma City
    Oklahoma City, Oklahoma 73106, United States
    • Angela Harnden · Contact
    Recruiting
  • Tulsa
    Tulsa, Oklahoma 74120, United States
    • Angela Harnden · Contact
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05534568
Lead sponsor
University of Oklahoma
Collaborators
University of Oklahoma Outreach, Oklahoma Mental Health and Substance Abuse, Arnall Family Foundation, Oklahoma Human Services, OU Dodge Family College of Arts and Sciences, Casey Family Programs, University of Washington
Responsible party
Sponsor
First posted
Sep 9, 2022
Start date
Nov 15, 2022
Primary completion
Nov 15, 2025 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Jun 7, 2024

Study contacts

Julie Gerlinger, Ph.D.
Contact
jgerlinger@ou.edu
(405) 325-1751
Angela Harnden, Ph.D.
Contact
aharnden@ou.edu
(405) 919-9708
Erin Maher, Ph.D.
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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