Evaluating a One-Year Version of the Parent-Child Assistance Program (PCAP-1)

• ClinicalTrials.gov Identifier: NCT06163651
• Recruitment Status: Not yet recruiting
• First Posted: December 11, 2023
• Last Update Posted: April 30, 2024
• Sponsor: University of Oklahoma
• Collaborators: Children's Bureau - Administration for Children and Families; Oklahoma Human Services; Oklahoma Department of Mental Health and Substance Abuse
• Information provided by (Responsible Party): University of Oklahoma

Study Description

Brief Summary:

The proposed project seeks to achieve four objectives that will, collectively, evaluate the effectiveness of a one-year version of the Parent-Child Assistance Program (PCAP-1) -a model for a home visitation and case management program for parents who used substances during pregnancy. First, the proposed project aims to estimate the causal impact of PCAP-1 on preventing the need for foster care and promoting reunification. Second, the project will estimate PCAP-1's effectiveness in achieving other program goals: parent recovery, parent's connection with needed comprehensive community resources, and preventing future children from being exposed to drugs and alcohol prenatally. Third, the project intends to estimate any cost savings from the perspective of the state. Finally, causal evidence of program effectiveness across the prior three objectives would enable PCAP-1 to be rated according to strength of evidence on relevant federal registries (i.e., FFPSA and HOMEVEE). All four objectives will be pursued by leveraging an ongoing randomized control trial (RCT) of PCAP with substantial backing from public and private partners, including the Oklahoma Department of Human Services (OK's Title IV-E agency). This quasi-experimental project will recruit 40 new participants to receive PCAP-1 services and will use data on participants from the existing trial for the control group. This extension of the original RCT is efficient and highly feasible, drawing upon and adapting an existing evaluation framework and protocol. This design will facilitate an unbiased estimation of one-year program effectiveness while also enabling a comparison of the differential effectiveness of PCAP-1 and the original three-year PCAP model as a secondary benefit. Moreover, given that the population PCAP serves are disproportionately poor and low-income and PCAP is designed to be culturally competent and relevant, PCAP-1 harbors the potential to address inequities in child welfare outcomes, substance use disorder treatment services, and child and family well- being by improving outcomes for these families. With a strong backing by state agencies and community partners, the evaluation of PCAP-1 will contribute to a knowledge gap in the field for in-home program models serving a highly vulnerable population with high rates of child welfare involvement and use of foster care.

Condition or disease	Intervention/treatment	Phase
Alcohol Use Disorder; Substance Use Disorders; Pregnancy Related; Alcohol Use Complicating Pregnancy, Unspecified Trimester; Fetal Alcohol Syndrome; Fetal Alcohol Spectrum Disorders; Drug Use Disorders; Drug Use Complicating Pregnancy, Unspecified Trimester; Maternal Drugs Affecting Fetus; Maternal; Alcohol Use, Affecting Fetus	Behavioral: Parent-Child Assistance Program - One-Year Version	Not Applicable

Detailed Description:

PCAP is a three-year, intensive case management intervention for pregnant and postpartum individuals who have used substances during their current or most recent pregnancy. PCAP provides mothers with a case manager with whom they meet biweekly, in the home or in other community settings. Case managers coach mothers in setting their own goals and taking steps to achieve them, provide practical assistance, serve as role models, and offer emotional support and encouragement. They connect mothers to community resources and recovery supports tailored to the participant's needs and goals. On average, case managers carry a caseload of 16 mothers/families, receive at least biweekly individual clinical supervision by a master's-level clinician, biweekly group supervision, and individual consultation with their supervisor whenever needed. Case managers work with the mother and the child with prenatal substance exposure and other family members in support of the participant's goals and recovery.

This project seeks to evaluate a one-year version of PCAP (PCAP-1), aligned with the time frame of the FFPSA federal matching funds for prevention programs with evidence of effectiveness. PCAP was originally designed to be a three-year intervention as it was theorized that three years comprised a realistic time frame during which a mother can form a strong therapeutic alliance with a case manager and undergo the developmental process of making gradual behavioral changes. Indeed, for many clients, who may never have known the steady presence of a trusted parent or other individual in their lives, the beginning of that process is slow and tentative. The three-year duration was also chosen to provide clients with ample time to make fundamental changes in their lives. In the standard PCAP program, preparing for post-intervention does not begin until Year 3. The investigators now theorize that the most significant changes happen within the first year, and a one-year program may be a better fit for many clients, especially those who are child welfare-involved. A shorter duration may also serve as an external motivator to clients in completing their goals, as they will know they have a one-year time frame during which they will have assistance, and they will sooner begin anticipating the post-intervention period. A one-year intervention is also indicated under the parameters of the FFPSA as the FFPSA provides matching funds for one year of evidence-based in-home services to child welfare-involved families to prevent the need for foster care.

The specific objectives of this project are to:

1. Establish causal evidence of effectiveness of PCAP-1 in preventing the need for foster care and promoting reunification
2. Establish causal evidence of the effectiveness of PCAP-1 in achieving other key goals: (a) Parent achieves and stays in recovery, (b) Parent accesses comprehensive services to meet needs to achieve and maintain a healthy family life, and (c) Subsequent substance-exposed pregnancies are prevented.
3. Estimate cost savings associated with PCAP-1 from the perspective of the agency administering a state's child welfare system.
4. Lay the groundwork to be rated by relevant federal registries according to strength of the program's evidence of effectiveness for purposes of sustainability, spread, and replication.

In 2021, PCAP and a rigorous randomized controlled trial (RCT) testing the benefits of the program was implemented in Oklahoma. Two Oklahoma sites began enrolling clients in late 2022. Each site will enroll 100 participants, randomly assigned to the experimental groups: treatment and control (services as usual). The project proposed herein will complement the ongoing RCT but offers the important additional benefit of adapting and extending PCAP to a third study site and evaluating a one-year version of PCAP. This adaptation is important because client and case manager mindsets and priorities may be very different when faced with a one-year time frame rather than a three-year time frame. Furthermore, a one-year version of PCAP is more consistent with the Adoption and Safe Families Act timelines for permanency hearings to start to establish the permanency plan for a child in foster care.

Using the recruitment strategies described above, 40 eligible people will be recruited into PCAP-1 at a third PCAP site. The one-year intervention will take place over the three-year project period, with enrollment into PCAP-1 occurring on a rolling basis over the first two years of this study. Two case managers will each be assigned 20 PCAP-1 participants over the study period to avoid the n=1 confounding problem.

This quasi-experimental design incorporates a control group to compare one-year outcomes with the PCAP-1 participants. The approximately 40 people making up the control group will come from the original PCAP study. As such, all control group participants are placed in that group based on random assignment in the original, ongoing trial, while all new referrals for PCAP-1 will receive PCAP-1 services. The control group will complete the same surveys, and at the same time period, as the PCAP-1 participants for direct comparisons between groups. This will involve adding a new data collection period for current control participants in the original trial. Although the control group is enrolled in a three-year study, their experiences during the first year likely suffice as a suitable control group for the proposed study, particularly as recruitment strategies and study eligibility are the same in both studies. The control group will be matched with the PCAP-1 treatment group based on characteristics such as age, race/ethnicity, and socioeconomic status.

The long- and short-form Addiction Severity Index (ASI) and the investigator-created Self-Administered Survey (SAS) will capture outcome data about individuals in both the PCAP-1 and control groups. The 5th edition of the ASI, one of the most widely used measures of SUD severity, is a semi- structured interview that assesses the following domains: medical status, employment/support status, substance use, legal status, family history, family/social relationships, and psychiatric status. Its psychometric properties have been tested extensively. With regard to substance use, it assesses substance, number of days of use in the past 30 days, last time used, route of administration, and use without a prescription. It also assesses SUD treatment receipt. Along with the standard set of ASI question batteries, the instrument administered to study participants also contains multiple PCAP-specific question batteries. These items are designed to elicit information on children in the household, access and use of community services, and childhood history and experiences. The long-form ASI will be administered to all study participants at baseline, and the short-form ASI, which contains all proposed outcomes, will be administered 12 months after baseline.

The SAS was developed by the investigator team drawing primarily upon standardized scales and measures used in addictions research and related subfields that have solid psychometric properties. Many of these standardized scales and measures have also been found to be valid measures for use in diverse populations. The investigators took these studies into account when selecting our measures. Information from the SAS is secondary to our 3 main research objectives and questions. However, the research team is proposing to collect this information for the PCAP-1 evaluation as it broadens the outcomes examined, maximizes the research investment, and allows us to also report on important other outcomes in addictions research, as well as examine mechanisms of success. It also allows for a small focus on child development outcomes. The SAS elicits information from clients along several dimensions covering a wide range of client behavior metrics and social psychological concepts important for addiction research, including criminal justice involvement, additional adverse childhood experiences (ACEs) from an expanded ACEs instrument, social support, maternal attachment (antenatal and postnatal), mental health, self-esteem and self- efficacy, addiction beliefs, parenting practices, and parent/child experiences and child development. These measures allow us to examine both predictors of success, as well as additional outcomes stemming from the intervention. The SAS will be administered to all study participants at baseline and at 12 months following baseline.

Additionally, PCAP case managers will complete a standardized questionnaire regarding each of their clients (treated participants) at 6 and 12 months. These biannual case-manager reports characterize clients' substance use and SUD treatment; child custody and child welfare involvement; family planning and pregnancy; connection to services for client, child/ren, and other family members; housing; income and employment; education; and criminal justice involvement. Shorter monthly reports will document whether the client and index child were seen and, if not, efforts to reach the client; substance use and SUD treatment; and child custody and child welfare involvement.

Moreover, this project's state agency partnership will also contribute complementary child welfare administrative data to the evaluation of PCAP-1. OK DHS maintains the Statewide Automated Child Welfare Information System, commonly referred to as KIDS. The KIDS data system contains an entry for each referral or action incident regarding potential child neglect or abuse. These referral records contain a wealth of information about the referred child, the primary and secondary caregivers, and the nature and outcome of the referral. Regarding the referred child, the records contain information on demographics, measures of mental and physical health, an assessment of child safety, and education. For caregivers, the KIDS system contains information on demographics, criminal justice system involvement, employment and income, and receipt of public assistance, among other data elements. In terms of the nature and outcome of the referral, KIDS contains information on the reason for the referral as well as its disposition. The data contain detailed information on removals, placement into foster care, and subsequent placements over time. Finally, the records indicate whether and when the child was reunified with the original caregiver after removal. These data will allow us to document child removals and reunifications, in the context of child safety (from recurrence of maltreatment).

An increasing number of social program or policy evaluations include a benefit-cost analysis (BCA) as a component of the broader evaluation. Through their focus on monetizing programmatic costs and benefits, BCAs can be a powerful tool for communicating the impact of a social program on state coffers and social welfare. The investigators plan to conduct an analysis that tallies the PCAP-1 cost savings accruing to the state's child welfare agency through the reduced use of foster care and the prevention of substance-exposed newborns. The investigators will calculate these budgetary impacts over the limited time span of one year. The upside of this limited scope is the ability to estimate the costs and benefits with greater certainty. It is also consistent with policymakers' general conceptualization of costs and benefits.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Promoting Parent and Child Well-Being and Reducing the Need for Foster Care: An Evaluation of a One-Year, Home-Visiting and Case Management Program for People Using Substances During Pregnancy
• Estimated Study Start Date: September 2024
• Estimated Primary Completion Date: July 30, 2026
• Estimated Study Completion Date: September 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; The treatment group consists of pregnant or parenting people who meet our eligibility criteria. Mothers in the treatment group will receive PCAP-1 services through the work of highly trained, closely-supervised case managers.	Behavioral: Parent-Child Assistance Program - One-Year Version; Case managers work closely with mothers over the course of one year, meeting the mothers in their own homes when possible, to help them set goals and take advantage of available resources.
No Intervention: Control Group; The control group consists of pregnant or parenting people who meet our eligibility criteria and are enrolled in the original PCAP trial. Mothers in the control group are provided with a service and referral resource and can access "services as usual" in the community, but will not receive PCAP in any form.

Outcome Measures

Primary Outcome Measures :

1. Proportion of target children not placed in foster care [ Time Frame: Measured after 1 year of study participation. ]
   The target child is not placed in foster care.
2. Mother acquires or maintains child custody [ Time Frame: Measured after 1 year of study participation. ]
   The mother has physical custody of the target child.
3. Proportion of mothers abstinent from drugs and/or alcohol [ Time Frame: Measured after 1 year of study participation. ]
   The mother is abstinent from drugs and/or alcohol for at least 6 months.
4. Proportion of mothers on a reliable method(s) of birth control [ Time Frame: Measured after 1 year of study participation. ]
   The mother is on a reliable method of birth control.
5. Reduction in costs to state agencies [ Time Frame: Measured after 1 year of study participation. ]
   Reduced costs to state agencies following PCAP-1 participation.

Secondary Outcome Measures :

1. Proportion of mothers who acquire or maintain stable housing [ Time Frame: Measured after 1 year of study participation. ]
   The mother resides in stable housing.
2. Proportion of mothers who acquire or maintain employment [ Time Frame: Measured after 1 year of study participation. ]
   The mother is employed.
3. Proportion of mothers who enroll in or complete an educational program [ Time Frame: Measured after 1 year of study participation. ]
   The mother has completed or is enrolled in an educational program.
4. Proportion of mothers who receive public benefits [ Time Frame: Measured after 1 year of study participation. ]
   The mother receives public benefits (e.g., housing, food, cash)
5. Proportion of mothers with ongoing criminal justice involvement [ Time Frame: Measured after 1 year of study participation. ]
   The mother has had new involvement with the criminal justice system.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• People who have used alcohol, opioids, or other drugs during pregnancy
• People 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 within a 40-mile radius of Enid, OK (for treatment group)
• Resides within a 40-mile radius of OKC and Tulsa (for control group)

Exclusion Criteria:

• Incarcerated at the time of enrollment
• Enrollment in a similar set of services (e.g., ReMerge, Systems of Care (SOC))
• 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

Contacts and Locations

Contacts

Contact: Julie Gerlinger, PhD; 405-325-1751; jgerlinger@ou.edu

Sponsors and Collaborators

University of Oklahoma

Children's Bureau - Administration for Children and Families

Oklahoma Human Services

Oklahoma Department of Mental Health and Substance Abuse

Investigators

• Principal Investigator: Julie Gerlinger, PhD; University of Oklahoma
• Principal Investigator: Erin Maher, PhD; University of Oklahoma
• Principal Investigator: Susan Stoner, PhD; University of Washington

More Information

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT06163651
• Other Study ID Numbers: 90FA3011
• First Posted: December 11, 2023
• Last Update Posted: April 30, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oklahoma:

Parent-Child Assistance; Substance Use Disorder; Addictions; Drug Dependence; Drug Abuse; Alcohol Dependence; Alcohol Abuse; Alcoholism; Recovery Services; PCAP

Additional relevant MeSH terms:

Fetal Alcohol Spectrum Disorders; Pregnancy Complications; Substance-Related Disorders; Alcoholism; Alcohol Drinking; Drinking Behavior; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Fetal Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Alcohol-Induced Disorders