17 Clinical Trials for Various Conditions
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
Children will receive comprehensive evaluations through the UOHSC ABC program The assessment for the child will include: medical issues (including medication), dysmorphic examination, intellectual assessment, academic achievement, language, and motor skills. This program will provide appropriate non-study services and referrals. Eligible families will be randomly assigned to treatment group or control group. Treatment group will receive Parent Child Interaction Therapy (PCIT). The Control group will receive standard referrals and services through the ABC program and the parent education/advocacy component of the project.
Children will receive comprehensive evaluations through the Children's Research Triangle (CRT) clinical program. The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by one of the clinic pediatricians and final diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be randomized into either a Treatment or Control group. The Treatment group will receive (in addition to standard referrals) neurocognitive habilitation and psychotherapy services as well as parent psychoeducation. The Control group will be referred for intervention through existing community and school-based agencies.
Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.
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.
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
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.
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 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.
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. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not precisely known. At this time, there are no programs to prevent FAS in Russia. The results of our previous study, focus groups with health professionals, pregnant women and their partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and print resources related to this topic. Based on the initial findings, this proposal aims to develop and evaluate in a clinical trial informational brochures for women to increase knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested are: * 1. Compared to the control group (CG) of women who receive a standard locally available flyer with health recommendations, women in the experimental groups who are exposed to printed information on FAS will show significantly more knowledge about FAS, significantly less acceptance of any alcohol use during pregnancy, and reduced drinking at one month follow-up assessment. * 2. The group exposed to a brochure with negative images (IGN - Intervention group with a "negative brochure") regarding drinking during pregnancy will show significantly greater change in the predicted directions compared to the group exposed to positive images (IGP - Intervention group with a "positive" brochure) at the one month follow-up assessment.
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
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.
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 in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome. Materials will be available in Spanish and English
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.
Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative study between the CDC and three universities. The hypothesis of the study is that a greater proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after participating in the Information Plus Counseling (IPC) intervention than do those in the Information Only(IO) control group.