Parent-Child Assistance Program for Substance Use During Pregnancy

Recruiting at 1 trial location

Overseen By Julie Gerlinger, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Incarcerated, Enrollment in similar services, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support mothers in Oklahoma who have used alcohol, opioids, or other drugs during pregnancy. It evaluates the Parent-Child Assistance Program (PCAP), which assigns case managers to help mothers recover and improve their living conditions over three years. The trial will measure outcomes such as reduced substance use, better family planning, and less involvement with the criminal justice system. Women who are pregnant or have a child under 24 months exposed to substances and live in Oklahoma City or Tulsa may be eligible to participate.

As an unphased trial, this study offers participants a unique opportunity to contribute to valuable research that could enhance support systems for mothers in similar situations.

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 prior data suggests that the Parent-Child Assistance Program is safe for mothers and their children?

Research has shown that the Parent-Child Assistance Program (PCAP) is generally safe for participants. Studies have found that this program helps reduce pregnancies affected by alcohol and supports mothers in avoiding drugs and alcohol. These benefits suggest that the program is well-received and poses no safety risks. Participants work with trained case managers who assist them in making positive life changes. No reports of negative effects have emerged from participation in PCAP, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-Child Assistance Program (PCAP) because it offers a unique, hands-on approach to helping pregnant women who have used substances like alcohol or opioids. Unlike standard care options that typically provide a list of resources or standard services, PCAP involves personalized support from highly trained case managers. These case managers work closely with the mothers, offering guidance and assistance tailored to each family's needs. This personalized and proactive approach aims to improve outcomes for both the mothers and their children, addressing the complex challenges that come with substance use during pregnancy.

What evidence suggests that the Parent-Child Assistance Program is effective for substance use during pregnancy?

Research has shown that the Parent-Child Assistance Program (PCAP), which participants in this trial may receive, can assist mothers who have used alcohol or drugs during pregnancy. In a study with women in Washington State, those who joined PCAP experienced better health and social outcomes. The program reduces pregnancies affected by alcohol and encourages abstinence from alcohol and drugs. It also supports job placement and better family planning choices. Evidence suggests that PCAP can improve outcomes for children and stabilize families. These findings highlight PCAP's potential to support mothers and their children. ^{1 2 5 6 7}

Who Is on the Research Team?

Erin Maher, Ph.D.

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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

Women who have used alcohol, opioids, or other drugs during pregnancy

Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma

Women who are pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Parent-Child Assistance Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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 Group Active Control 1 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

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Oklahoma Human Services

Collaborator

Trials

2

Recruited

280+

OU Dodge Family College of Arts and Sciences

Collaborator

Trials

1

Recruited

200+

University of Oklahoma Outreach

Collaborator

Trials

1

Recruited

200+

Oklahoma Mental Health and Substance Abuse

Collaborator

Trials

1

Recruited

200+

Casey Family Programs

Collaborator

Trials

2

Recruited

440+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Arnall Family Foundation

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

The Parent-Child Assistance Program (P-CAP) is a 3-year intervention aimed at preventing alcohol-exposed births among high-risk women, and it has been found to be cost-effective in reducing the incidence of fetal alcohol spectrum disorder.

The study emphasizes the importance of not only reducing alcohol use during pregnancy but also providing effective contraceptive measures as part of the program to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An economic evaluation of the parent-child assistance program for preventing fetal alcohol spectrum disorder in Alberta, Canada. Thanh, NX., Jonsson, E., Moffatt, J., et al.[2016]

North Carolina has been a leader in providing comprehensive treatment for perinatal substance use disorders for over 25 years, emphasizing wraparound services and support for mothers and families.

The state's approach includes a strong focus on medication-assisted treatment and understanding the critical fourth trimester, which helps improve outcomes for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Substance Use Disorders Treatment. Godwin, M., Green, S., Jones, H., et al.[2020]

Women who used opiates, cocaine, or amphetamines during pregnancy had a nearly four times higher rate of postpartum readmission (PPR) compared to non-users, with a rate of 54.6 per 1000 versus 14.0 per 1000.

Even after adjusting for various factors, the study found that drug users had almost double the odds of experiencing PPR (OR = 1.95), highlighting the significant impact of substance use on maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Salemi, JL., Raza, SA., Modak, S., et al.[2021]

The PuP program, designed to support parents with a history of substance dependence, showed immediate benefits for both mothers and their children, as reported by 23 women in qualitative interviews.

Participants expressed a strong desire to improve their relationships with their children, and as they progressed through the program, they gained confidence in their parenting abilities, highlighting the program's positive impact on family functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers experiences of the Parenting Under Pressure Program (PuP) in a Residential Therapeutic Community: A qualitative study. Ivers, JH., Harris, A., McKeown, P., et al.[2021]

The study involved 47 mothers with substance abuse issues and their children aged 2-7, testing an intervention that combined parent training with a contingency management program to improve parenting behaviors.

Mothers in the incentive group (PTI) showed higher rates of daily monitoring of child behavior, leading to significant reductions in child externalizing problems and improvements in internalizing problems, suggesting that incentives can enhance the effectiveness of parent training for children at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent training plus contingency management for substance abusing families: a Complier Average Causal Effects (CACE) analysis. Stanger, C., Ryan, SR., Fu, H., et al.[2021]

Infants born to women who abuse substances are at a higher risk for growth and developmental issues, as well as neonatal abstinence syndrome, which can lead to long-term health complications.

The negative impact on these infants is compounded by the mother's use of legal substances like cigarettes and alcohol, and the challenging environments they grow up in, highlighting the need for healthcare interventions to support both the mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug use in pregnancy: parameters of risk. Chasnoff, IJ.[2019]

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.

Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]

The Early Start Program effectively addresses maternal substance abuse by providing comprehensive support, including screening, early intervention, and ongoing counseling, directly within the prenatal clinic setting.

The program's integration with a perinatal health services research unit enhances its effectiveness and offers a model that can be adapted for use in other managed care environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Start: an obstetric clinic-based, perinatal substance abuse intervention program. Armstrong, MA., Lieberman, L., Carpenter, DM., et al.[2019]

A specialized case management program for mothers and their children exposed to drugs in utero showed that higher intensity services led to better outcomes, including increased rates of drug abstinence and higher custody retention at the 2-year follow-up.

The study highlights the clinical and economic benefits of providing intensive support to drug-using mothers, suggesting that such programs can effectively improve both maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of child case management services for offspring of drug-dependent women. Jansson, LM., Svikis, DS., Beilenson, P.[2022]

The Washington State Parent-Child Assistance Program, which supports at-risk mothers who abuse alcohol and drugs, showed significant improvements in outcomes for 216 women over a three-year period, particularly in areas like alcohol/drug treatment completion and subsequent deliveries without exposure to substances.

Results from the program's original demonstration (1991-1995) were not only maintained but improved in later replications (1996-2003), indicating the effectiveness of this community-based intervention model across different sites and suggesting that public policies may have positively influenced these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites. Grant, TM., Ernst, CC., Streissguth, A., et al.[2019]

In a study of 603 pregnant women with cocaine abuse, those in the Pregnancy Substance Abuse Program (PSAP) had significantly better treatment retention, with a drop-out rate of only 11.3% compared to 38.6% in traditional treatment.

The PSAP group also showed a higher completion rate of outpatient treatment (34.4% vs. 13.5%), demonstrating that pregnancy-specific interventions can enhance treatment outcomes for substance-abusing pregnant women with minimal additional costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pregnancy-specific interventions to a traditional treatment program for cocaine-addicted pregnant women. Weisdorf, T., Parran, TV., Graham, A., et al.[2019]

The Family Center Program, which provides comprehensive care and support for substance-abusing pregnant women, has successfully increased the number of women seeking prenatal care, leading to improved pregnancy outcomes.

Despite these improvements, serious complications such as low birth weight and perinatal mortality remain common, indicating that a stable, drug-free environment is crucial for further enhancing outcomes for both mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy in a drug-abusing population. Fitzsimmons, J., Tunis, S., Webster, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11020811/

Study protocol for a randomized controlled trial of the ... Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed ...

2. pcap.psychiatry.uw.edu pcap.psychiatry.uw.edu/what-is-pcap/evidence-base/

Evidence Base Among these women, over half (i.e., 56.3% or 12.3% of the entire sample) used alcohol and/or drugs during the subsequent pregnancy. Consistent with our main ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-16670-z

Evaluating outcomes of a three-year case management ... We used self-reported data from 3,165 women aged 18 to 45 years enrolled in the Parent-Child Assistance Program in Washington State between May ...

4. cebc4cw.org cebc4cw.org/program/parent-child-assistance-program/

Parent-Child Assistance Program (PCAP) The purpose of the study was to examine the efficacy of the Parent-Child Assistance Program (PCAP) for improving health and social outcomes of high-risk ...

5. journals.plos.org journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0000580

Nurturing families: One year pilot outcomes for a modified ... PCAP has been shown to reduce alcohol exposed pregnancies, promote AOD abstinence, increase employment and family planning and improve child outcomes.

6. pcap.psychiatry.uw.edu pcap.psychiatry.uw.edu/wp-content/uploads/2025/03/PCAP_Summary_of_Evidence_2.6.25.pdf

Washington State Parent-Child Assistance Program (PCAP) Without intervention, mothers who are in early recovery or ongoing substance use are at risk of negative personal and parental outcomes. Many, once themselves ...

7. ou.edu ou.edu/content/dam/pcap/docs/PCAP%20Manual%20Aug%202023.pdf

Parent-Child Assistance Program (PCAP) ... in PCAP must self-report some level of substance use during pregnancy. Why ... In 2005, evaluation data were used to compare outcomes from two Washington State ...