The Oklahoma Parent-Child Assistance Program

NCT05534568 | Recruiting

• 1 other identifier: 14394
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Substance Use Disorders; Pregnancy Related; Alcohol Use Disorder (AUD); Alcohol Use Complicating Pregnancy, First Trimester; Alcohol Use Complicating Pregnancy, Second Trimester; Alcohol Use Complicating Pregnancy, Third Trimester; Alcohol Use Complicating Pregnancy, Unspecified Trimester; Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium; Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Drug Use Disorders; Drug Use Complicating Pregnancy, First Trimester; Drug Use Complicating Pregnancy, Second Trimester; Drug Use Complicating Pregnancy, Third Trimester; Drug Use Complicating Pregnancy, Unspecified Trimester; Drug Use Complicating Pregnancy, Childbirth, and the Puerperium; Maternal Drugs Affecting Fetus

Keywords

Parent-child assistance; Substance use disorder; addictions; drug dependence; drug abuse; alcohol dependence; alcohol abuse; alcoholism; recovery services; PCAP

Outcome Measures

Primary Outcomes (2)

• Change in using a reliable method(s) of birth control

  The mother is on a reliable method(s) of birth control.

  Measured every six months up to 4 years

• Change in abstinence

  The mother is abstinent from alcohol and drugs for at least six months.

  Measured every six months up to 4 years

Secondary Outcomes (6)

• Change in criminal justice involvement

  Measured every six months up to 4 years

• Change in child custody

  Measured every six months up to 4 years

• Change in stable housing

  Measured every six months up to 4 years

• Change in employment

  Measured every six months up to 4 years

• Change in education

  Measured every six months up to 4 years

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Other: Parent-Child Assistance Program

Control Group

NO 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.

Interventions

Parent-Child Assistance Program OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Women who have used alcohol, opioids, or other drugs during pregnancy
• Women who are (1) pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or (2) have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years
• Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma

You may not qualify if:

• Not meeting eligible criteria above
• Incarcerated at the time of enrollment
• Enrollment in similar services (i.e., ReMerge, Systems of Care (SOC) and/or Family Treatment Courts (FTC) and heading to Termination of Parental Rights (TPR))
• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Oklahoma Outreach: collaborator
• Oklahoma Mental Health and Substance Abuse: collaborator
• Arnall Family Foundation: collaborator
• Oklahoma Human Services: collaborator
• OU Dodge Family College of Arts and Sciences: collaborator
• Casey Family Programs: collaborator
• University of Washington: collaborator

Study Sites (2)

Oklahoma City

Oklahoma City, Oklahoma, 73106, United States

RECRUITING

Tulsa

Tulsa, Oklahoma, 74120, United States

RECRUITING

Related Publications (1)

• Maher EJ, Stoner SA, Gerlinger J, Ferraro AC, Lepper-Pappan H. Study protocol for a randomized controlled trial of the Parent-Child Assistance Program: a case management and home visiting program for people using substances during pregnancy. Trials. 2024 Apr 16;25(1):264. doi: 10.1186/s13063-024-08098-6.

  PMID: 38627843 DERIVED

Related Links

• PCAP Website

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Fetal Alcohol Spectrum Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Erin Maher, Ph.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Gerlinger, Ph.D.

CONTACT

(405) 325-1751; jgerlinger@ou.edu

Angela Harnden, Ph.D.

CONTACT

(405) 919-9708; aharnden@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: September 9, 2022
• Study Start: November 15, 2022
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)