RECRUITING

The Oklahoma Parent-Child Assistance Program

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma

Quick Facts

Study Start:2022-11-15
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05534568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Women who have used alcohol, opioids, or other drugs during pregnancy
  3. * 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
  4. * Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma
  1. * Not meeting eligible criteria above
  2. * Incarcerated at the time of enrollment
  3. * 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))
  4. * 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

Contacts and Locations

Study Contact

Julie Gerlinger, Ph.D.
CONTACT
(405) 325-1751
jgerlinger@ou.edu
Angela Harnden, Ph.D.
CONTACT
(405) 919-9708
aharnden@ou.edu

Principal Investigator

Erin Maher, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

Oklahoma City
Oklahoma City, Oklahoma, 73106
United States
Tulsa
Tulsa, Oklahoma, 74120
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Erin Maher, Ph.D., PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-15
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2022-11-15
Study Completion Date2026-11-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • 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