Parent-Child Assistance Program for Substance Use Disorder

(PCAP-1 Trial)

Recruiting at 1 trial location

Overseen By Julie Gerlinger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Incarceration

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to help parents who have used substances improve their family situation and reduce the need for foster care. It aims to support parents in their recovery journey, connect them with community resources, and ensure children avoid exposure to drugs and alcohol. The trial involves the Parent-Child Assistance Program - One-Year Version, a one-year home visitation and case management program, to determine its effectiveness in achieving these goals. Parents who may be a good fit for this trial live with children under six within 50 miles of Enid or Oklahoma City, OK, and have faced challenges with substance use. As an unphased trial, this study offers a unique opportunity for parents to access supportive resources and potentially enhance their family's well-being.

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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Parent-Child Assistance Program is safe for parents with substance use disorder?

Research shows that the Parent-Child Assistance Program (PCAP) is generally well-liked by participants. Studies have found that PCAP helps reduce alcohol-related pregnancies, encourages avoiding alcohol and other drugs, increases job opportunities, and improves family planning and child well-being. Available data report no negative effects or safety concerns, suggesting the program is safe for participants. Trained case managers provide support, and past participants have found this approach helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Parent-Child Assistance Program (PCAP) is unique because it focuses on providing intensive, personalized support to parents with substance use disorders through the work of highly trained, closely-supervised case managers. Unlike standard care options that may include outpatient counseling or medication-assisted treatment, PCAP emphasizes a holistic approach that addresses not only substance use but also the social and environmental factors affecting families. Researchers are excited about this program because it aims to create long-term positive outcomes for both parents and children, potentially breaking the cycle of substance abuse within families.

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

Research has shown that the Parent-Child Assistance Program (PCAP) can greatly benefit families. In this trial, participants in the treatment group will receive PCAP-1 services. Studies have found that PCAP helps more people stop using alcohol and drugs, with the percentage of individuals staying sober increasing from 31% upon leaving the program to 51% later on. It also reduces alcohol-affected pregnancies and encourages better family planning. Additionally, PCAP increases families' use of community services, supporting their recovery and well-being. These findings suggest that the program effectively improves life for parents dealing with substance use issues and their children. ^{3 6 7 8 9}

Who Is on the Research Team?

Julie Gerlinger, PhD

Principal Investigator

University of Oklahoma

Erin Maher, PhD

Principal Investigator

University of Oklahoma

Susan Stoner, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for parents over 18 with children under 6, living within a 50-mile radius of Enid, OK. It's designed to help those who have struggled with substance use during pregnancy and aims to prevent foster care needs and promote family reunification.

Inclusion Criteria

I live within 50 miles of Enid, OK.

I am over 18 years old.

I am a parent with a child under 6 living with me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one year of PCAP-1 services, including home visits and case management

52 weeks

Biweekly visits (in-person or community settings)

Follow-up

Participants are monitored for outcomes such as child custody, housing stability, and employment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Parent-Child Assistance Program - One-Year Version

Trial Overview The trial tests a one-year version of the Parent-Child Assistance Program (PCAP-1), which includes home visitation and case management aimed at supporting parent recovery, connecting them with resources, and preventing future drug or alcohol exposure in children.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

The treatment group consists of parents who meet our eligibility criteria. Parents in the treatment group will receive PCAP-1 services through the work of highly trained, closely-supervised case managers.

Group II: Control Group Active Control 1 Intervention

The control group consists of parents who meet our eligibility criteria and are part of administrative data from the Oklahoma Department of Human Services in a comparable county to our intervention county, or from prior historical cases within the same county. Parents in the control group can access "services as usual" in the community, but will not receive PCAP in any form.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Oklahoma Human Services

Collaborator

Trials

2

Recruited

280+

Oklahoma Department of Mental Health and Substance Abuse

Collaborator

Trials

1

Recruited

80+

Children's Bureau - Administration for Children and Families

Collaborator

Trials

23

Recruited

40,900+

Oklahoma Department of Health and Human Services

Collaborator

Trials

2

Recruited

2,300+

Citations

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

Study protocol for a randomized controlled trial of the ... This study protocol describes a randomized controlled trial that aims to examine the effectiveness of the intervention compared to services as usual in ...

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

Evidence Base Between PCAP exit and post-program follow-up: Increase in abstinence from alcohol and drugs for at least 6 months at the time of interview (31% at exit vs. 51% ...

3. cebc4cw.org cebc4cw.org/program/parent-child-assistance-program/detailed

Parent-Child Assistance Program (PCAP) Measures utilized include the Addiction Severity Index with supplemental questions on pregnancy substance use, contraception, and use of community services.

4. 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.

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022323/

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.

7. hca.wa.gov hca.wa.gov/assets/program/parent-child-assistance-program-year-one-final-report-202209.pdf

PCAP year one final report - September 2022 This PCAP report covers the period from July 1, 2021 through June 30, 2022, for the 2021-2023 biennium.

8. ctv.veeva.com ctv.veeva.com/study/evaluating-a-one-year-version-of-the-parent-child-assistance-program

Evaluating a One-Year Version of the Parent-Child Assistance ... This quasi-experimental design incorporates a control group to compare one-year outcomes with the PCAP-1 participants. The approximately 40 ...

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

Parent-Child Assistance Program (PCAP) Program. Considerations. In 2005, evaluation data were used to compare outcomes from two Washington State PCAP replication sites with the original PCAP ...