Parent-Child Assistance Program for Substance Use During Pregnancy
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Disqualifiers: Incarcerated, Enrollment in similar services, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on helping mothers with substance use issues, so it's best to discuss your specific situation with the trial coordinators.
What data supports the effectiveness of the Parent-Child Assistance Program treatment for substance use during pregnancy?
Research shows that the Parent-Child Assistance Program (P-CAP) is cost-effective in preventing alcohol-exposed births, which can lead to fetal alcohol spectrum disorder. Additionally, similar programs that provide intensive support and case management have been effective in helping mothers reduce substance use and improve outcomes for their children.
12345Is the Parent-Child Assistance Program (PCAP) safe for use in humans?
The available research does not provide specific safety data for the Parent-Child Assistance Program (PCAP) itself, but it is a home visitation and harm reduction program aimed at preventing alcohol-exposed births, suggesting it is designed to be supportive and non-invasive.
12678How does the Parent-Child Assistance Program treatment differ from other treatments for substance use during pregnancy?
The Parent-Child Assistance Program (PCAP) is unique because it is a community-based intervention that focuses on home visitation to support at-risk mothers, specifically those who abuse alcohol and drugs during pregnancy. Unlike other treatments, PCAP provides long-term, personalized support over three years, helping mothers improve their parenting skills and maintain a stable, drug-free environment, which has shown to improve outcomes for both mothers and their children.
29101112Eligibility Criteria
This trial is for women over 18 in Oklahoma City or Tulsa who used alcohol, opioids, or drugs during pregnancy. It's for those pregnant or with a child under 24 months exposed to substances and not linked to services, or have a child with fetal alcohol spectrum disorder and are at risk of drinking while able to have more children.Inclusion Criteria
I am 18 years old or older.
Women who have used alcohol, opioids, or other drugs during pregnancy
Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma
+1 more
Exclusion Criteria
Incarcerated at the time of enrollment
Not meeting eligible criteria above
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
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive PCAP services through case managers over a three-year period
3 years
Regular home visits by case managers
Follow-up
Participants are monitored for substance use, child custody, employment, and other well-being outcomes
6 months
Surveys conducted every six months
Participant Groups
The Parent-Child Assistance Program (PCAP) is being tested. It supports mothers who've used substances during pregnancy by providing three years of case management. The study aims to help them get treatment, recover, access resources for independent living, and prevent future substance use in pregnancy.
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
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.
Parent-Child Assistance Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as Parent-Child Assistance Program for:
- Substance use disorder treatment and recovery support for pregnant and postpartum individuals
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
TulsaTulsa, OK
Oklahoma CityOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
Oklahoma Human ServicesCollaborator
OU Dodge Family College of Arts and SciencesCollaborator
University of Oklahoma OutreachCollaborator
Oklahoma Mental Health and Substance AbuseCollaborator
Casey Family ProgramsCollaborator
University of WashingtonCollaborator
Arnall Family FoundationCollaborator
References
An economic evaluation of the parent-child assistance program for preventing fetal alcohol spectrum disorder in Alberta, Canada. [2016]Parent-Child Assistance Program (P-CAP) is a 3-year home visitation/harm reduction intervention to prevent alcohol exposed births, thereby births with fetal alcohol spectrum disorder, among high-risk women. This article used a decision analytic modeling technique to estimate the incremental cost-effectiveness ratio and the net monetary benefit of the P-CAP within the Alberta Fetal Alcohol Spectrum Disorder Service Networks in Canada. The results indicate that the P-CAP is cost-effective and support placing a high priority not only on reducing alcohol use during pregnancy, but also on providing effective contraceptive measures when a program is launched.
Pregnancy in a drug-abusing population. [2019]Substance abuse in pregnancy places both mother and infant at extremely high risk. There is little information, however, about the impact of changing patterns of drug use and improvements in medical technology on pregnancy outcome. The Family Center Program utilizes a team approach to provide counseling, support, and education as well as complete medical care for substance-abusing pregnant women. We reviewed the records of women seen in the Family Center Program from 1981 to 1983 to evaluate the effect of intervention on pregnancy outcome. Complications, including prematurity, growth retardation, intrauterine fetal demise, and neonatal abstinence, were common, although early prenatal care and frequent visits appear to reduce the risk of low birth weight infants. Uncorrected perinatal mortality was 11/163 (67/1,000). Compared to earlier experience in this program, few women delivered with no prenatal care. Thus a program designed specifically for the needs of these women is successful in increasing the number seeking prenatal care and appears to improve pregnancy outcome. Despite this, serious problems are common and further improvement seems unlikely unless such women can be maintained in a stable, drug-free environment during their pregnancies.
Effectiveness of child case management services for offspring of drug-dependent women. [2022]Female drug users and their children have many medical and psychosocial problems, yet they often fail to follow through with prescribed treatments. The present study describes a specialized, case management program for children, birth through age 2, exposed to drugs in utero. Evaluation of program efficacy was examined by comparing 2-year outcomes for women who received different intensities of these child case management services. Mothers who received higher intensity care were more likely to be abstinent from illicit drugs and to have retained custody of their child(ren) at 2-year follow-up than those with lower intensity services. Study findings support clinical and economic efficacy of this model of care.
Parent training plus contingency management for substance abusing families: a Complier Average Causal Effects (CACE) analysis. [2021]Children of substance abusers are at risk for behavioral/emotional problems. To improve outcomes for these children, we developed and tested an intervention that integrated a novel contingency management (CM) program designed to enhance compliance with an empirically-validated parent training curriculum. CM provided incentives for daily monitoring of parenting and child behavior, completion of home practice assignments, and session attendance.
Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]The public health burden of opioid use disorder (OUD) among pregnant women has significantly increased in recent years. The Optimizing Pregnancy Treatment Interventions for Moms study was a pilot project that examined the feasibility of a patient navigation (PN) intervention model to reduce substance use and improve mental health, quality of life, and to increase engagement with treatment services among pregnant women with OUD.
Comparison of pregnancy-specific interventions to a traditional treatment program for cocaine-addicted pregnant women. [2019]Alcohol and drug use in pregnancy is a significant concern. There is a paucity of treatment programs for substance-abusing pregnant women, especially if indigent. Furthermore, treatment retention is compromised when the drug of choice is crack-cocaine. This paper reports the results of a study comparing treatment retention of cocaine-abusing indigent pregnant women before and after incorporating pregnancy-specific interventions. Audits were performed on 603 charts of women enrolled between 1988 and 1994 in either a traditional treatment program (n = 114) or in the Pregnancy Substance Abuse Program (PSAP) (n = 489). Differences in treatment retention were found between the two treatment groups. Drop-out rates from the inpatient component of treatment were significantly lower in the PSAP group than in the control group (11.3% vs. 38.6%, p
The association between use of opiates, cocaine, and amphetamines during pregnancy and maternal postpartum readmission in the United States: A retrospective analysis of the Nationwide Readmissions Database. [2021]Substance use during pregnancy has increased in the United States, with adverse consequences for mother and baby. Similarly, postpartum readmission (PPR) imposes physical, emotional, and financial stressors causing disruption to family functioning and childcare. We used national data to estimate the extent to which women who used opiates, cocaine, and amphetamines during pregnancy are at increased risk of PPR.
Early Start: an obstetric clinic-based, perinatal substance abuse intervention program. [2019]Maternal substance abuse is a serious problem with significant adverse effects to mothers, fetuses, and children. The Early Start Program provides pregnant women in a managed care organization with screening and early identification of substance abuse problems, early intervention, ongoing counseling, and case management by a licensed clinical social worker located in the prenatal clinic, where she is an integral part of the prenatal team. We describe the development of the Early Start Program, its administrative history, and how it has interfaced with clinicians and administrators. We also highlight two important program characteristics: the partnership with a perinatal health services research unit and the degree to which the program could be "exported" to other managed care settings.
Perinatal Substance Use Disorders Treatment. [2020]North Carolina has been at the forefront of offering treatment for perinatal substance use disorders for over 25 years. Wraparound services, understanding of the fourth trimester, the importance of medication-assisted treatment, and learning from past false predictions regarding illicit prenatal exposure contribute to a nurturing, supportive approach for the mother, child, and families.
Drug use in pregnancy: parameters of risk. [2019]With the increasing incidence of substance abuse in the United States, there has been a concomitant increase in the number of women becoming pregnant while using substances of abuse. The infant delivered to a drug-addicted woman is at risk for problems of growth and development as well as neonatal abstinence, and is also at increased risk of infections and exposure to HIV. The long-term outcome of these infants is influenced not only by the mother's use of illicit substances but by the frequent additional use of licit substances, such as cigarettes and alcohol. The drug-seeking environment in which many of these children are raised also may impair maximal development for these infants. In addition, many women from substance-abusing backgrounds lack a proper model for parenting and require intervention by the health care community to guide them in their roles as parents. Thus, multiple factors in the lives of these children, compounded by the early neurobehavioral deficits of drug-exposed newborns, earmark these infants to be at high risk for continuing developmental and later school problems.
Mothers experiences of the Parenting Under Pressure Program (PuP) in a Residential Therapeutic Community: A qualitative study. [2021]Several studies suggest parental substance use, while not always the case, exposes children to a higher risk of physical, psychological, behavioral and emotional problems. Identifying interventions that best support the parent and child needs is imperative. The PuP programme aims to improve family functioning and child outcomes by supporting parents who are or have been drug or alcohol dependent. PuP combines psychological principles relating to parenting, child behavior and parental emotion regulation within a case-management model. The current study was the first evaluation of the PuP program in a residential setting globally. Twenty-three women took part in pre and post-program qualitative interviews. Guilt was a dominant theme across interviews. The principal expectation of participants was to improve their relationships and access to their children. The benefits of the PuP program to the women and their children, as reported by participants, were immediate and direct. As the women progressed through the program, they were visibly building belief in their abilities to parent.
Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites. [2019]Home visitation interventions show promise for helping at-risk mothers, yet few programs have been developed and evaluated specifically for alcohol and drug-abusing pregnant women. This study examines outcomes among 216 women enrolled in the Washington State Parent-Child Assistance Program, a three-year intervention program for women who abuse alcohol and drugs during an index pregnancy. Pretest-posttest comparison was made across three sites: the original demonstration (1991-1995), and the Seattle and Tacoma replications (1996-2003). In the original demonstration, the client group performed significantly better than controls. Compared to the original demonstration, outcomes at replication sites were maintained (for regular use of contraception and use of reliable method; and number of subsequent deliveries), or improved (for alcohol/drug treatment completed; alcohol/ drug abstinence; subsequent delivery unexposed to alcohol/drugs). Improved outcomes at replication sites are not attributable to enrolling lower-risk women. Public policies and programs initiated over the study period may have had a positive effect on outcomes. Study findings suggest that this community-based intervention model is effective over time and across venues.