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The Oklahoma Parent-Child Assistance Program

Primary Purpose

Substance Use Disorders, Pregnancy Related, Alcohol Use Disorder (AUD)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-Child Assistance Program
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use Disorders focused on measuring Parent-child assistance, Substance use disorder, addictions, drug dependence, drug abuse, alcohol dependence, alcohol abuse, alcoholism, recovery services, PCAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Oklahoma CityRecruiting
  • TulsaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in using a reliable method(s) of birth control
The mother is on a reliable method(s) of birth control.
Change in abstinence
The mother is abstinent from alcohol and drugs for at least six months.

Secondary Outcome Measures

Change in criminal justice involvement
The mother has had no new involvement with the criminal justice system.
Change in child custody
The mother has physical custody of the index child.
Change in stable housing
The mother resides in stable housing.
Change in employment
The mother is employed.
Change in education
The mother has completed or is enrolled in educational program.
Change in use of public benefits
The mother receives public benefits (e.g., housing, food, cash)

Full Information

First Posted
June 8, 2022
Last Updated
May 25, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05534568
Brief Title
The Oklahoma Parent-Child Assistance Program
Official Title
A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
November 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Parent-Child Assistance Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in using a reliable method(s) of birth control
Description
The mother is on a reliable method(s) of birth control.
Time Frame
Measured every six months up to 4 years
Title
Change in abstinence
Description
The mother is abstinent from alcohol and drugs for at least six months.
Time Frame
Measured every six months up to 4 years
Secondary Outcome Measure Information:
Title
Change in criminal justice involvement
Description
The mother has had no new involvement with the criminal justice system.
Time Frame
Measured every six months up to 4 years
Title
Change in child custody
Description
The mother has physical custody of the index child.
Time Frame
Measured every six months up to 4 years
Title
Change in stable housing
Description
The mother resides in stable housing.
Time Frame
Measured every six months up to 4 years
Title
Change in employment
Description
The mother is employed.
Time Frame
Measured every six months up to 4 years
Title
Change in education
Description
The mother has completed or is enrolled in educational program.
Time Frame
Measured every six months up to 4 years
Title
Change in use of public benefits
Description
The mother receives public benefits (e.g., housing, food, cash)
Time Frame
Measured every six months up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Gerlinger, Ph.D.
Phone
(405) 325-1751
Email
jgerlinger@ou.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Harnden, Ph.D.
Phone
(405) 919-9708
Email
aharnden@ou.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Maher, Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Harnden
Facility Name
Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Harnden

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://Ou.edu/pcap
Description
PCAP Website

Learn more about this trial

The Oklahoma Parent-Child Assistance Program

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