FASD Prevention R33
R33
Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)
1 other identifier
interventional
184
1 country
1
Brief Summary
This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2026
CompletedFirst Posted
Study publicly available on registry
September 18, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
Study Completion
Last participant's last visit for all outcomes
June 30, 2029
September 18, 2026
September 1, 2026
2 years
September 11, 2026
September 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Urinalysis results for alcohol use
An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking with ≥150 ng/mL for EtG as a cutoff value.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for tobacco use
Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use with ≥ 80ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for cannabis use
Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum
Secondary Outcomes (7)
Birth weight
Birth
Gestational age at birth
Birth
Head circumference
Birth
Apgar score
Birth
NICU admission
Birth to 3 months postpartum
- +2 more secondary outcomes
Study Arms (2)
Usual Care
ACTIVE COMPARATORParticipants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Intervention
EXPERIMENTALParticipants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
Interventions
Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Eligibility Criteria
You may qualify if:
- (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.
You may not qualify if:
- Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philadelphia College of Osteopathic Medicinelead
- RTI Internationalcollaborator
- University of Cape Towncollaborator
Study Sites (1)
University of Cape Town
Cape Town, South Africa
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
September 11, 2026
First Posted
September 18, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
September 18, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- After study outcomes are published for 3 years
- Access Criteria
- those with the permission of the principal investigator and the team investigators
A limited data set in which names and other personal health identifiers are removed will be supplied to researchers on request. The data will be made available after the publication of the study results. Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the principal investigator and the team for review, if appropriate. The data sets will be ready for use and can be converted to other analytic tools.