Clinical trial NCT05534568: The Oklahoma Parent-Child Assistance Program
Official title: A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Parent-child assistance
Substance use disorder
addictions
drug dependence
drug abuse
alcohol dependence
alcohol abuse
alcoholism
recovery services
PCAP
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: University of Oklahoma Outreach
name: Oklahoma Mental Health and Substance Abuse
name: Arnall Family Foundation
name: Oklahoma Human Services
name: OU Dodge Family College of Arts and Sciences
name: Casey Family Programs
name: University of Washington
First posted: 2022-09-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in using a reliable method(s) of birth control
timeFrame: Measured every six months up to 4 years
measure: Change in abstinence
timeFrame: Measured every six months up to 4 years
Secondary outcomes:
measure: Change in criminal justice involvement
timeFrame: Measured every six months up to 4 years
measure: Change in child custody
timeFrame: Measured every six months up to 4 years
measure: Change in stable housing
timeFrame: Measured every six months up to 4 years
measure: Change in employment
timeFrame: Measured every six months up to 4 years
measure: Change in education
timeFrame: Measured every six months up to 4 years
measure: Change in use of public benefits
timeFrame: Measured every six months up to 4 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Erin Maher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: