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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{2 9 10 11 12}

Research Team

Erin Maher, Ph.D.

Principal Investigator

University of Oklahoma

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An economic evaluation of the parent-child assistance program for preventing fetal alcohol spectrum disorder in Alberta, Canada. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Pregnancy in a drug-abusing population. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of child case management services for offspring of drug-dependent women. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Parent training plus contingency management for substance abusing families: a Complier Average Causal Effects (CACE) analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of pregnancy-specific interventions to a traditional treatment program for cocaine-addicted pregnant women. [2019]

7. Ireland 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Early Start: an obstetric clinic-based, perinatal substance abuse intervention program. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Perinatal Substance Use Disorders Treatment. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Mothers experiences of the Parenting Under Pressure Program (PuP) in a Residential Therapeutic Community: A qualitative study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites. [2019]