Clinical trials: Alcohol Exposed Pregnancy
Alcohol Consumption, Fetal Alcohol Syndrome Disorders
A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living…
- Conditions
- Alcohol Consumption, Fetal Alcohol Syndrome Disorders, Students
- Trial name
- NCT00219336
- Testing
- Self-guided Motivational Intervention, Informational Only
- Where
- United States
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Nova Southeastern University
Fetal Alcohol Syndrome (FAS)
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases.
- Trial name
- Neuro-SAF (NCT02558933)
- Testing
- Epigallocatechin gallate
- Where
- Spain
- Volunteers
- 36 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Prenatal Alcohol Exposure, Prenatal Tobacco Exposure
Choices4Health: Intervention to Prevent Substance-exposed Pregnancy
This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing…
- Conditions
- Prenatal Alcohol Exposure, Prenatal Tobacco Exposure, Prenatal Marijuana Exposure
- Trial name
- C4H (NCT03633149)
- Testing
- Computer tablet-delivered C4H, Person-delivered C4H, Brief Advice
- Where
- United States
- Volunteers
- 219 people, healthy volunteers welcome
- Sponsor
- University of Texas at Austin
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder
- Trial name
- NCT01911299
- Testing
- Choline
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- San Diego State University
Alcohol Exposed Pregnancy
Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition.
- Trial name
- EARLY RCT (NCT01446653)
- Testing
- Motivational Interviewing plus feedback, Video, Informational Brochure
- Where
- 2 sites in United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Prenatal Alcohol Exposure
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Hypothesis: Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process models, namely an…
- Trial name
- ALTEMO (NCT03793920)
- Testing
- Facial Emotion Test
- Where
- 2 sites in France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE).
- Trial name
- TNS-PAE (NCT06847165)
- Testing
- Trigeminal Nerve Stimulation (TNS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, Los Angeles
Alcohol Use, Smoking
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
Choices Plus, a randomized controlled study, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol- and tobacco-exposed…
- Conditions
- Alcohol Use, Smoking, Contraception
- Trial name
- ChoicesPlus (NCT01032772)
- Testing
- Choices Plus, Information
- Where
- 2 sites in United States
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- University of Texas at Austin
Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders
Preventing FAS/ARND in Russian Children
The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children.
- Conditions
- Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
- Trial name
- NCT01961050
- Testing
- Dual-Focused Brief Physician Intervention (DFBPI), Services as usual
- Where
- 2 sites in Russia
- Volunteers
- 767 people
- Sponsor
- University of Oklahoma
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders.
- Trial name
- NCT04395196
- Testing
- Choline bitartrate
- Where
- South Africa
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Wayne State University
Risk for an Alcohol-Exposed Pregnancy, Risk for Marijuana-Exposed Pregnancy
CHOICES-TEEN Randomized Controlled Trial
This randomized controlled trial will: 1) Test the efficacy of the CHOICES-TEEN (CT) intervention compared with an Attentional Control (AC) condition on reducing the risk of substance-exposed pregnancy (SEP) and HIV/STI among…
- Conditions
- Risk for an Alcohol-Exposed Pregnancy, Risk for Marijuana-Exposed Pregnancy, Risk for Substance-Exposed Pregnancy, HIV Risk
- Trial name
- NCT05368571
- Testing
- CHOICES-TEEN, Health and Life Skills Education
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Danielle Parrish
Foetal Exposure During Pregnancy
Computerized Tool for Preventing Prenatal Drinking
An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial.
- Trial name
- NCT02337361
- Testing
- Electronic SBI
- Where
- 2 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Public Health Institute, California
Fetal Alcohol Syndrome, Substance Abuse
Fetal Alcohol Damage Prevention Study
The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.
- Trial name
- NCT00696085
- Testing
- Brief motivational intervention
- Where
- United States
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Fetal Alcohol Syndrome
Prenatal Alcohol Biomarker Study in Uruguay
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.
- Trial name
- NCT02600624
- Where
- 2 sites in United States, Uruguay
- Volunteers
- 1,412 people
- Sponsor
- Northwestern University
Prenatal Alcohol Exposure, Fetal Alcohol Spectrum Disorders
Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD
This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.
- Trial name
- NCT06935461
- Testing
- Families Moving Forward Bridges
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Washington
Brain Development, Choline Nutrition
Pilot Study of Prenatal Choline Supplementation
A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of…
- Trial name
- NCT07699393
- Testing
- Choline bitartrate
- Where
- South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Wayne State University
Alcohol Drinking
Reducing Alcohol Exposed Pregnancies
The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women.
- Trial name
- NCT05766761
- Testing
- Intervention condition, the usual prenatal care plus the alcohol intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- New York University
Fetal Alcohol Spectrum Disorders
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
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.
- Trial name
- DiGFASD (NCT04072809)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Indiana University
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS)
Development of Education Materials for Prevention of FAS in Russia
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder, Alcohol Use Complicating Pregnancy, Unspecified Trimester
- Trial name
- NCT01971398
- Testing
- Positive FASD education brochure, Negative FASD education brochure, Active comparator (a general women's health brochure)
- Where
- 3 sites in United States, Russia
- Volunteers
- 422 people
- Sponsor
- University of Oklahoma
Alcohol Exposed Pregnancy, Unplanned Pregnancy
Optimizing a Digital AEP Risk Intervention With Native Women and Communities
The purpose of Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol.
- Conditions
- Alcohol Exposed Pregnancy, Unplanned Pregnancy, Alcohol Use, Unspecified, Contraception Use
- Trial name
- CARRIINative (NCT06324929)
- Testing
- CARRII Native Rapid Pilot Testing
- Where
- United States
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- University of Virginia