Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04072809
Other study ID # 1801900355
Secondary ID U01AA026103
Status Completed
Phase
First received
Last updated
Start date July 6, 2018
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not. This study will test if genetics (or DNA) explains these differences. We hope this will help improve treatments and interventions for people with fetal alcohol spectrum disorders (FASD). Participants in this study (or their parents or legal guardians) will be asked to: - Answer some questions about themselves. These questions ask about their demographic background (such as gender, race, ethnicity, income, and education), their health history, and their mother's health during her pregnancy with them (if that information is known). - Speak with study staff briefly by phone or video chat to confirm enrollment in the study and ask any questions they have. - Take photographs of their face. - Provide a saliva sample for genetic research. Participants can complete the study at home from anywhere in the world. The questions can be answered online, over the phone, or on paper. Adopted families are welcome to enroll. The study pays for all shipping costs.


Description:

Fetal Alcohol Syndrome (FAS) typically involves poor growth for age, particular facial characteristics, and cognitive deficiencies. Although FAS was first described in the literature over 40 years ago, significant challenges remain in the development of rapid and efficient approaches to identify individuals who were prenatally exposed to alcohol. Further, no widely available effective interventions or treatments to improve the long term outcomes of individuals with FAS and related disorders (collectively known as Fetal Alcohol Spectrum Disorders or FASD) exist, despite the high prevalence (as high as 33.5 per 1,000 in some communities) of FASD across the United States. The Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) seeks to address critical issues related to earlier and improved recognition of FASD, identify biomarkers of exposure, and elucidate the genetic risk factors contributing to FASD risk and resilience by conducting multidisciplinary projects and maintaining cooperative resources. This project is part of CIFASD's ongoing efforts and will specifically address the elucidation of genetic factors that contribute to risk and resilience in FASD. Prior work with animal models of FASD have identified genetic variants that contribute to alterations in facial morphology after exposure to alcohol during embryonic development (McCarthy et al., 2013). Prenatal alcohol exposure also activates immune pathway genes in animal models. The identification of these genetic factors suggest that genetic variation may similarly contribute to differences in response to prenatal alcohol exposure in humans. The goal of this project is to identify genetic variants that protect against or increase the effects of prenatal alcohol exposure in humans.


Recruitment information / eligibility

Status Completed
Enrollment 751
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 110 Years
Eligibility Inclusion Criteria: - Documented or suspected history of prenatal alcohol exposure OR Fetal Alcohol Spectrum Disorder (FASD) diagnosis - Speaks English Exclusion Criteria: - No documented or suspected history of prenatal alcohol exposure OR FASD diagnosis - Does not speak English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This study does not involve any interventions.

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facial Risk Score Facial Risk Score
Each participant's facial images will be evaluated and a Facial Risk Score will be assigned to each individual. This risk score is relative to all individuals participating in the study, and therefore will be updated at the end of each year. Final scores will be completed at the end of the study. The risk score is computer-based, with high scores indicating increased dysmorphology and low scores indicating decreased dysmorphology.
through study completion, an average of 1 year
Primary Whole Exome Sequencing (WES) Whole Exome Sequencing
After Facial Risk Scores have been assigned to each individual, two subsets of the study population will be selected: those with high risk scores, and those with low risk scores. Saliva samples from these subpopulations will be subjected to Whole Exome Sequencing (WES). Rare variant analysis will be performed in each gene to evaluate whether there are more rare variants in individuals from one group (e.g., high risk scores) compared to the other group (e.g., low risk scores). This will enable us to determine if the variant increases risk (more common in those with high risk scores) or increases resilience (more common in those with low risk scores).
through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Completed NCT01961050 - Preventing FAS/ARND in Russian Children N/A
Recruiting NCT05108974 - Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study Phase 2
Completed NCT02457676 - Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention N/A
Recruiting NCT06005181 - The Synchrony Study: Examining Music Training for Children With FASD N/A
Completed NCT04571463 - Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
Completed NCT03361293 - Cognitive Training and tDCS for Children With FASD N/A
Recruiting NCT05534568 - The Oklahoma Parent-Child Assistance Program N/A
Recruiting NCT05456321 - CIFASD 5 tDCS and Cognitive Training N/A
Completed NCT01911299 - Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders Phase 2
Recruiting NCT04332172 - Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy N/A
Recruiting NCT05960461 - Families Moving Forward (FMF) Connect Pro for Mental Health Providers N/A
Completed NCT05604014 - Feasibility Study of the My Health Coach App for Adults With FASD N/A
Terminated NCT03852550 - READYorNot[TM] Brain-Based Disabilities Trial N/A
Completed NCT02735473 - Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Phase 2
Completed NCT03782935 - Nutritional Risk Factors for FASD in Ukraine N/A
Not yet recruiting NCT04918043 - Alcohol Use During Pregnancy in Finland According to Meconium Samples
Completed NCT01149538 - Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure Phase 1/Phase 2
Completed NCT05028517 - Efficacy Trial of the FMF Connect Mobile Health Intervention N/A
Completed NCT04194489 - Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention N/A