View clinical trials related to Fetal Alcohol Spectrum Disorders.
Filter by:The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol exposure who meet research criteria for a fetal alcohol spectrum disorder. The main questions it aims to answer are: - Does music training improve behavioral regulation for children with an FASD - Does music training improve cognitive performance (attention and working memory) for children with an FASD. The study has two interventions for each participant: music listening and piano training. Each participant will either practice piano daily for 12 weeks or listen to pre-selected music daily for 12 weeks. The order of the interventions will be randomized across participants. Assessment will occur before and after participation in each 12 week intervention.
The goal of this clinical trial is to test a new provider-assisted version of the caregiver Families Moving Forward (FMF) Connect app ("FMF Connect Pro") with mental health providers in the United States. In FMF Connect Pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support families in using the FMF Connect caregiver app. Two different training methods will be compared with a waitlist group in this study. The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website. The main questions this study aims to answer are: - What is the proportion of agencies and providers who accept and participate in the clinical trial (Reach)? - Do study groups differ on provider outcome measures of Effectiveness (clients screened/diagnosed), Adoption (provider change in knowledge, self-efficacy), Implementation (practice change, FMF Connect Pro Dashboard usage), and Maintenance of FASD-informed care practice change? All mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.
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.
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).
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.
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
This study is a double-blind, placebo controlled, series of N-of-1 trials of individualised stimulant dose on ADHD symptomatology in children with FASD. The broad aim of this study is to contribute new evidence towards understanding treatment efficacy for ADHD symptoms in FASD. Specific aims are: 1. To assess the ongoing effectiveness of stimulant medication prescribed for ADHD symptoms in individual children with FASD of clinically prescribed stimulant medication compared to placebo to control ADHD symptoms (using behavioural and cognitive measures) in children with FASD and ADHD using a N-of-1 trial design. 2. To obtain pilot data to examine feasibility and tolerability of the planned N-of-1 trial design in children with FASD and ADHD for future and larger studies that might seek to examine if the different stimulant types are equally effective relative to placebo. 3. To review the multiple N-of-1 data to analyze key individual factors that mediate the effect of stimulants relative to placebo on ADHD symptoms, including underlying child factors (attention skills, cognitive function), sociodemographic factors and other prenatal exposures.
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.
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.
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.