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Parent-Child Assistance Program for Substance Use During Pregnancy

N/A
Recruiting
Led By Erin Maher, Ph.D.
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every six months up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial helps 200 mothers in Oklahoma who use alcohol/drugs during pregnancy & their children by providing support/resources for 3 years. Benefits include substance use disorder treatment, birth control, abstinence, child custody, & criminal justice involvement.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since PCAP involves social support rather than medical intervention, there aren't typical 'side effects' like you'd expect from medication. However, participants may experience emotional distress or other psychological impacts as they work through the program's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every six months up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every six months up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in abstinence
Change in using a reliable method(s) of birth control
Secondary study objectives
Change in child custody
Change in criminal justice involvement
Change in education
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 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 GroupActive Control1 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.

Find a Location

Who is running the clinical trial?

Oklahoma Human ServicesUNKNOWN
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Fetal Alcohol Spectrum Disorders
80 Patients Enrolled for Fetal Alcohol Spectrum Disorders
OU Dodge Family College of Arts and SciencesUNKNOWN
University of Oklahoma OutreachUNKNOWN
Oklahoma Mental Health and Substance AbuseUNKNOWN
University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,491 Total Patients Enrolled
7 Trials studying Fetal Alcohol Spectrum Disorders
1,475 Patients Enrolled for Fetal Alcohol Spectrum Disorders
Casey Family ProgramsUNKNOWN
1 Previous Clinical Trials
235 Total Patients Enrolled
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,369 Total Patients Enrolled
Arnall Family FoundationUNKNOWN
Erin Maher, Ph.D.Principal InvestigatorUniversity of Oklahoma

Media Library

Parent-Child Assistance Program Clinical Trial Eligibility Overview. Trial Name: NCT05534568 — N/A
Fetal Alcohol Spectrum Disorders Research Study Groups: Control Group, Treatment Group
Fetal Alcohol Spectrum Disorders Clinical Trial 2023: Parent-Child Assistance Program Highlights & Side Effects. Trial Name: NCT05534568 — N/A
Parent-Child Assistance Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534568 — N/A
~56 spots leftby Nov 2025