# Adventures in the Design and Trial of an Innovative FASD Risk Assessment: Integrating Known Risks with New Measures of Weekly Prenatal Alcohol Exposure, Maternal Mental Health, and Paternal Alcohol

> **NIH NIH R61** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $228,138

## Abstract

Project Abstract/Summary
 The two-phased research mechanism will permit us to design, pilot test, and validate the
efficacy of innovative new multivariate protocols for estimating actual risk for the birth of a
child with fetal alcohol spectrum disorders (FASD). In the R61 Phase we will research, create,
design, and pilot test new protocols for: 1) interviewing mothers (with biomarker validation) to
determine maternal alcohol consumption on a daily/weekly basis across pregnancy and
postpartum alcohol use during breastfeeding to assess their specific contributions to child traits
and severity of FASD outcomes; 2) determining maternal experience with stress, trauma, and
mental health status during pregnancy and their contribution to the severity of effect on FASD
diagnostic traits; 3) interviewing fathers regarding paternal traits that contribute to the risk for
FASD from exposure to teratogens such as alcohol, other drugs, and environmental toxins during
pre-conception; and 4) establishing a comprehensive, summary FASD risk score from the above
innovations when combined with multiple other empirically-established proximal and distal
variables of risk.
 The R33 Phase will then initiate an exploration of a multivariate, comprehensive
approach to FASD risk via two applications for better understanding FASD etiology. One
application is prospective and the other retrospective. In the prospective study, 200 women (and
as many of their partners as we can consent) will be recruited from prenatal clinics, and their
offspring will be assessed at six weeks and nine months postpartum and diagnosed by pediatric
dysmorphologists and a multidisciplinary team. The second application of the new methods will
gather the new data retrospectively and link the data to two existing cohorts of maternal/child
dyads whom we have followed over time to assess their FASD status and the severity of their
physical, neurodevelopmental, and behavioral traits. Both of these studies will add new insight to
our long-term quest to understand more completely the respective contributions of a broad range
of host, agent, and environmental factors to the etiology of FASD. This R33 Phase will provide
substantial validation of the weekly alcohol use data, mental health status assessments, paternal
questionnaire, and FASD risk score innovations via the clinical assessment of the offspring of
each pregnancy. In developing this more comprehensive approach to FASD risk, both study
phases draw on our existing clinical epidemiology infrastructure, the experience of our multi-
disciplinary team, and the participants in existing longitudinal cohorts.

## Key facts

- **NIH application ID:** 10817811
- **Project number:** 5R61AA030066-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Carol L Cheatham
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $228,138
- **Award type:** 5
- **Project period:** 2023-04-01 → 2025-09-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10817811

## Citation

> US National Institutes of Health, RePORTER application 10817811, Adventures in the Design and Trial of an Innovative FASD Risk Assessment: Integrating Known Risks with New Measures of Weekly Prenatal Alcohol Exposure, Maternal Mental Health, and Paternal Alcohol (5R61AA030066-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10817811. Licensed CC0.

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