Clinical Digest: Recent Clinical Trials on Fetal Alcohol Spectrum Disorder
To assist researchers and healthcare practitioners in staying up-to-date with the latest advancements in clinical research, the Clinical Digest Team has compiled a comprehensive list of recent clinical trials related to Fetal Alcohol Spectrum Disorder. These trials are organized by their release dates for your convenience. (Last updated on: 2025-05-02)
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TABLE 1: Clinical Digest: Recent Clinical Trials on Fetal Alcohol Spectrum Disorder
| Clinical Trial | Contact(s) | Date | |
|---|---|---|---|
| 1 | Randomized Controlled Trial of The My Health Coach App for Adults With Fetal Alcohol PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are: Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life? All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, … |
CHRISTIE PETRENKO; | 2025-04-01 |
| 2 | Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Purpose: This study is testing a new counseling program called Counselling for Alcohol Problems in Pregnancy or CAP-Pre, designed to help pregnant women in South Africa to reduce their alcohol use and improve their well-being. Alcohol use during pregnancy can harm babies, leading to Fetal Alcohol Spectrum Disorders (FASD), which can cause lifelong health and developmental problems. Currently, … |
DANIELA C. FUHR; | 2025-02-10 |
| 3 | Dialectical Behavior Therapy for Adolescents with Fetal Alcohol Spectrum Disorders Feasibility Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to test the feasibility of dialectical behavior therapy for adolescents (DBT-A) with fetal alcohol spectrum disorders (FASD). In partnership with a community mental health practice, Genesee Valley Psychology (GVP), two cohorts of five adolescents with FASD and their caregivers will participate in an already existing comprehensive DBT-A program (including individual therapy, group skills training, and 24/7 phone coaching). This program has been adapted for neurodivergent teens, … |
CHRISTIE PETRENKO; | 2024-12-24 |
| 4 | Fetal Alcohol Spectrum Disorder (FASD): Clinical Description and Search for Epigenetic Biomarkers for Diagnostic Purposes PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific epigenetic signature for Fetal Alcohol Spectrum Disorder, in order to provide early diagnostic markers, … |
CENTRE HOSPITALIER UNIVERSITAIRE DE LA RÉUNION | 2024-06-12 |
| 5 | Optimizing A Digital AEP Risk Intervention With Native Women and Communities PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: 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. |
KAREN INGERSOLL; | 2024-05-16 |
| 6 | Adapting and Testing A Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: South Africa (SA) has a long history of social and health disparities, resulting in the world’s highest rate of fetal alcohol spectrum disorder (FASD; 111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, … |
YUKIKO WASHIO; | 2023-04-01 |
| 7 | Feasibility Study of The My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to test a new smartphone app for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being. |
CHRISTIE PETRENKO; | 2023-03-01 |
| 8 | A Randomised Controlled Study of Dog Assisted Therapy: Comparing A Short and A Long Version Program for Patients with Fetal Alcohol Spectrum Disorder PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD. |
HOSPITAL UNIVERSITARI VALL D’HEBRON RESEARCH INSTITUTE | 2022-02-20 |
| 9 | Attention Management Trial for Children With FASD – A N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: 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. |
ALISON CRICHTON; | 2022-02-14 |
| 10 | Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Fetal Alcohol Syndrome Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US. Urban American Indian and Alaska Native (AIAN) young women are at high risk for alcohol exposed pregnancies (AEPs) which can cause FASD. In this project, the inverstigators will test the effectiveness of a culturally adapted mobile health intervention to prevent AEP, using social media to recruit AIAN young women from urban centers across the nation. |
CAROL KAUFMAN; | 2021-08-04 |
| 11 | Hyperbaric Oxygen Therapy Vs. Cognitive Training for Fetal Alcohol Spectrum Disorder; A Prospective, Randomized Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Fetal Alcohol Spectrum Disorder (FASD) describes a wide range of adverse physical, behavioral and cognitive effects resulting from prenatal alcohol exposure (PAE) during embryonic and fetal development. A number of clinical studies have presented evidence regarding the physiological effects of HBOT on metabolically dysfunctional brain regions that might be related to FASD. The aim of the study is to compare the effect of HBOT vs. neurocognitive training on neurobehavioral function in FASD. |
ASSAF HAROFEH MEDICAL CENTER | 2021-01-01 |
| 12 | Substance Use Treatment and Access to Resources (STARS) Project PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, … |
DAVID BARD; | 2020-12-16 |
| 13 | CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to find out if there is a benefit to using the MyREADY Transition\[TM\] BBD App for brain-based disabilities, compared to not using it. To do this, some of the participants in this study will use the MyREADY Transition\[TM\] BBD App and others will not use the App. Everyone will continue to get the same care they have been getting (their usual care). The study team wants to see how youth will use the MyREADY Transition\[TM\] BBD App as they are getting ready to leave the children’s hospital or children’s treatment centre. And, … |
JAN WILLEM GORTER; | 2020-06-22 |
| 14 | Food and Alcohol Behavior Study: Meaningful Enhancement PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 years and older. Additionally, this study will determine the effect of folate supplementation on mood, cognition, sleep patterns, and alcohol, nicotine, and other drug use. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention. |
JULIE CROFF; | 2019-08-14 |
| 15 | The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across The Life Span: Continuing Prevention and Longitudinal Epidemiology PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Screen women of childbearing age (15 – 44 years) for high risk drinking in antenatal clinics of the established research sites in the Western Cape Province of South Africa (SA). While there are multiple reasons for this screening, … |
PHILIP A MAY; | 2019-08-06 |
| 16 | Development, Implementation, and Evaluation of An Internet-based Behavioural Sleep Intervention for Children With NDD and Insomnia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems. Poor sleep can have significant consequences for children’s physical and psychosocial health, as well their caregivers’ well-being. The impact of sleep problems on daytime functioning is even greater in children with NDD. Although there are a range of factors that may disturb sleep in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia. There is some evidence that behavioural interventions can be effective in improving sleep in children with NDD. However, … |
PENNY CORKUM; | 2019-06-10 |
| 17 | Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Native CHOICES is a randomized controlled trial of an adapted intervention to reduce the risk of alcohol exposed pregnancies in American Indians and Alaska Natives (AI/ANs). We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation or in Rapid City in South Dakota who are 18-44 years old, have risky drinking behaviors, are not currently pregnant but are able to become pregnant, and are sexually active but not using effective contraception. |
MICHAEL MCDONELL; | 2019-03-28 |
| 18 | Fetal Alcohol Spectrum Disorder-Is This A Ciliopathy? PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Urine sample and exhaled Nitric Oxide will analyzed and compared between children diagnosed with Fetal Alcohol Spectrum Disorder and healthy control. Pilot study- 5 children in each group |
HELLY GOEZ; | 2018-09-01 |
| 19 | Parent Emotion Socialization and Child Emotion Regulation in FASD PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about the emotion regulation skills of children with fetal alcohol spectrum disorders (FASD) and different strategies that may improve these skills. This study is also testing whether a training program taught to caregivers is helpful. Children will be asked to: – Complete a brief measure of verbal and nonverbal problem-solving skills. – Play two computer games. – Have their heart rate measured while completing a task that is designed to be mildly disappointing. Two ECG pads are placed on the chest with a small recorder. – … |
CHRISTIE PETRENKO; | 2018-08-13 |
| 20 | Dissecting The Genetics of Fetal Alcohol Spectrum Disorders PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: 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, … |
TATIANA FOROUD; | 2018-07-06 |
| 21 | Development of An Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of the study is to validate epigenetic changes as biomarkers in a prospective sampling of newborn blood samples collected at birth (umbilical cord blood) and during routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure levels by PEth blood spot testing. |
STEFAN MAXWELL; | 2018-04-12 |
| 22 | Dog-Assisted Therapy for Children and Adolescents With FASD: A Randomized Controlled Pilot Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD. |
RAQUEL VIDAL; | 2018-04-02 |
| 23 | Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 – 16 years) with prenatal alcohol exposure (PAE). |
JEFFREY WOZNIAK; | 2017-11-20 |
| 24 | Self-Regulation in Adolescents With FASD: The Efficacy of A Targeted Intervention PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with FASD often struggle with self-regulation, or the ability to control thoughts, emotions and actions, which can lead to many long-term problematic life circumstances. This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD using a targeted intervention. Researchers adapted the Alert Program®, a developed intervention targeting self-regulation in children, to be appropriate for an adolescent FASD population. Participants are split into two groups: an FASD intervention group, … |
UNIVERSITY OF ALBERTA | 2016-09-01 |
| 25 | Choline Supplementation As A Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures. |
JEFFREY R WOZNIAK; | 2016-06-01 |
| 26 | Prevention of Fetal Alcohol Spectrum Disorder (FASD) By The Use of Technology PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues. IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD. The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, … |
ANDY GREENSHAW; | 2015-11-01 |
| 27 | Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic effects induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births, making this a public health problem of epidemic proportion. Even though considerable efforts have been aimed at identifying children with FASD, … |
PATRICK J. MCGRATH; | 2014-07-01 |
| 28 | Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure. |
JENNIFER THOMAS; | 2013-05-01 |
| 29 | Evaluating The Effectiveness of An Attachment-Focused Intervention in Preschool Children With Fetal Alcohol Spectrum Disorder (FASD) or At-risk for FASD: A Randomized Controlled Field Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Study Summary: This study is being conducted in order to rigorously evaluate the real-world effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk for FASD, as delivered under routine practice conditions. Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list control group receiving standard services, the treatment group receiving COS will show greater improvement in caregiver behaviour, as well as child emotional and behavioural outcomes. |
ANA HANLON-DEARMAN; | 2012-03-01 |
| 30 | Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning A Stage II Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include: 1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women. 2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), … |
STEVEN J. ONDERSMA; | 2011-04-01 |
| 31 | Reducing Alcohol Exposed Pregnancy Risk PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, … |
KAREN INGERSOLL; | 2007-02-01 |
| 32 | Early Identification of Affected Children and Nutritional Risk Factors for FASD in Ukraine PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Interventional study randomizing pregnant women at two sites in Ukraine who have or have not already consumed moderate to heavy levels of alcohol in pregnancy to receiving a standard prenatal vitamin supplement with or without additional choline supplement or standard of care (recommendation to take vitamin supplements) through the remainder of pregnancy, and to compare neurobehavioral performance of the offspring on the Bayley Scales of Infant Development at 12 months of age between groups. The overall sample size target was 300 alcohol exposed and 300 low or unexposed across both sites. |
CHRISTINA CHAMBERS; | 2006-06-01 |