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Fetal Alcohol Syndrome clinical trials

View clinical trials related to Fetal Alcohol Syndrome.

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NCT ID: NCT06163651 Not yet recruiting - Pregnancy Related Clinical Trials

Evaluating a One-Year Version of the Parent-Child Assistance Program

PCAP-1
Start date: September 2024
Phase: N/A
Study type: Interventional

The proposed project seeks to achieve four objectives that will, collectively, evaluate the effectiveness of a one-year version of the Parent-Child Assistance Program (PCAP-1) -a model for a home visitation and case management program for parents who used substances during pregnancy. First, the proposed project aims to estimate the causal impact of PCAP-1 on preventing the need for foster care and promoting reunification. Second, the project will estimate PCAP-1's effectiveness in achieving other program goals: parent recovery, parent's connection with needed comprehensive community resources, and preventing future children from being exposed to drugs and alcohol prenatally. Third, the project intends to estimate any cost savings from the perspective of the state. Finally, causal evidence of program effectiveness across the prior three objectives would enable PCAP-1 to be rated according to strength of evidence on relevant federal registries (i.e., FFPSA and HOMEVEE). All four objectives will be pursued by leveraging an ongoing randomized control trial (RCT) of PCAP with substantial backing from public and private partners, including the Oklahoma Department of Human Services (OK's Title IV-E agency). This quasi-experimental project will recruit 40 new participants to receive PCAP-1 services and will use data on participants from the existing trial for the control group. This extension of the original RCT is efficient and highly feasible, drawing upon and adapting an existing evaluation framework and protocol. This design will facilitate an unbiased estimation of one-year program effectiveness while also enabling a comparison of the differential effectiveness of PCAP-1 and the original three-year PCAP model as a secondary benefit. Moreover, given that the population PCAP serves are disproportionately poor and low-income and PCAP is designed to be culturally competent and relevant, PCAP-1 harbors the potential to address inequities in child welfare outcomes, substance use disorder treatment services, and child and family well- being by improving outcomes for these families. With a strong backing by state agencies and community partners, the evaluation of PCAP-1 will contribute to a knowledge gap in the field for in-home program models serving a highly vulnerable population with high rates of child welfare involvement and use of foster care.

NCT ID: NCT05534568 Recruiting - Pregnancy Related Clinical Trials

The Oklahoma Parent-Child Assistance Program

Start date: November 15, 2022
Phase: N/A
Study type: Interventional

The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy. This study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma. This evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and/or with kinship providers), and (4) criminal justice involvement.

NCT ID: NCT05385328 Recruiting - Clinical trials for Fetal Alcohol Syndrome

Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations

EYEFUL
Start date: November 1, 2022
Phase:
Study type: Observational

Physical and cognitive changes provoked by a pathology worsen the functional capability of the individual making it more difficult to perform Activities of Daily Living (ADLs) and causing dependency and/or disability. There are standardized observational tests for the clinical assessment of the degree of functional limitation in basic or instrumental ADLs (e.g., Assessment Motor and Process Skills - AMPS). On the other hand, all these tests bear the problem of the subjectivity of the evaluator in the analysis. The presence of the evaluator in the test may have an influence in the way a subject performs ADLs. The goal of the project is to develop a methodology to design, implement and validate automatic clinical tests of functional limitation, that: 1) give objective assessments with clinical validity, and 2) remove the interference in the test execution caused by the physical presence of the evaluator.

NCT ID: NCT04395196 Recruiting - Clinical trials for Fetal Alcohol Spectrum Disorders

RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

Start date: April 13, 2023
Phase: Phase 2
Study type: Interventional

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. Animal studies have shown that choline supplementation can mitigate effects of PAE on growth and development. Choline, an essential nutrient, serves as a methyl-group donor for DNA methylation and is a constituent of the neurotransmitter acetylcholine and a precursor to major components of cell membranes. In an R21 feasibility trial, 70 heavy drinkers were randomly assigned to receive a daily dose of 2g of choline or a placebo from initiation of antenatal care to delivery in Cape Town, South Africa, where the incidence of heavy drinking during pregnancy and fetal alcohol syndrome are among the highest in the world. When compared with infants in the placebo arm, infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning, demonstrated markedly better recognition memory on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ, and had better postnatal gains in weight and head circumference. Key features of this study included the higher choline dose (4.4 times adequate intake (AI), compared to 1.7-2.5 in previous human studies) and initiation of treatment early in pregnancy. We are now conducting a fully-powered, double-blind, randomized, placebo-controlled choline supplementation trial in heavy drinking pregnant women from a rural community in South Africa (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed; (3) to use innovative methods in causal inference analysis to examine protocol adherence as an important source of variation in treatment efficacy and to identify sociodemographic factors associated with non-compliance in order to facilitate implementation of the intervention protocol in clinical settings; and (4) in exploratory analyses, to examine whether maternal choline supplementation is particularly effective in women with lower dietary choline intake or poor nutritional status.

NCT ID: NCT04332172 Recruiting - Clinical trials for Fetal Alcohol Spectrum Disorders

Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy

e-Health
Start date: May 19, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out if pregnant women screening positive for alcohol risk like the brief alcohol intervention application that the investigators have developed (called the MommyCheckup, which is a technology-delivered SBIRT, or e-SBIRT), and if it helps them to reduce alcohol use. The investigators also wish to test whether e-SBIRT effects can be enhanced by booster sessions and/or tailored text messages.

NCT ID: NCT03371641 Recruiting - Clinical trials for Fetal Alcohol Syndrome

In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

ALCOBRAIN
Start date: January 27, 2017
Phase: N/A
Study type: Interventional

This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.

NCT ID: NCT02600624 Completed - Clinical trials for Fetal Alcohol Syndrome

Prenatal Alcohol Biomarker Study in Uruguay

Start date: August 18, 2016
Phase:
Study type: Observational

The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.

NCT ID: NCT01994603 Completed - HIV Clinical Trials

Expansion to Interdisciplinary HIV Prevention in Women

Start date: December 2012
Phase: N/A
Study type: Interventional

This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.

NCT ID: NCT01911299 Completed - Clinical trials for Fetal Alcohol Spectrum Disorders

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

NCT ID: NCT01149538 Completed - Clinical trials for Fetal Alcohol Spectrum Disorders

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Start date: July 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.