Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06163651 |
| Other study ID # |
90FA3011 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
September 30, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
University of Oklahoma |
| Contact |
Julie Gerlinger, PhD |
| Phone |
405-325-1751 |
| Email |
jgerlinger[@]ou.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
