FMF Connect for Fetal Alcohol Syndrome

Phase-Based Estimates
University of Rochester Medical Center, Rochester, NY
Fetal Alcohol Syndrome
FMF Connect - Other
All Sexes
Eligible conditions
Fetal Alcohol Syndrome

Study Summary

This study is evaluating whether a smartphone app can help parents/caregivers of children with fetal alcohol spectrum disorder.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether FMF Connect will improve 5 primary outcomes and 3 secondary outcomes in patients with Fetal Alcohol Syndrome. Measurement will happen over the course of baseline to 12 weeks.

12 weeks
Mean Mobile app rating tool
baseline to 12 weeks
Mean Effect size in Eyberg Child Behavior Inventory
Mean effect size in FASD knowledge
Mean effect size in Family Needs Questionnaire
Mean effect size in Parenting Sense of Competence scale for efficacy
Mean effect size in Parenting Sense of Competence scale for satisfaction
Mean effect size in Reasons for Children's Behavior measure
Mean effect size in self-care confidence

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
FMF Connect Intervention + Coaching

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. FMF Connect is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

FMF Connect Intervention + CoachingParticipants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
FMF Connect Intervention (no coaching)
Participants receive the FMF Connect mobile health app. They do not receive coaching.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Who is running the study

Principal Investigator
C. P.
Prof. Christie Petrenko, Research Associate Professor
University of Rochester

Closest Location

University of Rochester Medical Center - Rochester, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The child has lived with the parent/caregiver for at least 4 months and is expected to continue living with the parent/caregiver for at least 1 year. show original
and the child lives in a foreign country The parent who lives in the United States is taking care of their child who lives in a foreign country. show original
The person taking care of the child must be at least 18 years old. show original
The child has a condition that affects their development, which is known as FASD or PAE. show original
A caregiver of a child with FASD or prenatal alcohol exposure is someone who helps take care of the child show original
The parent/caregiver has a smartphone or ipad with iOS operating system
The child must be between the ages of 3 and 12. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for fetal alcohol syndrome?

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Studies have described various treatment regimens to treat the signs and symptoms of fetal alcohol syndrome. However, these recommendations do not provide evidence of their effectiveness because there are no randomized controlled trials or controlled studies to demonstrate benefit or toxicity for any of the recommendations.\nquestion: What are common treatments for migraine? answer: There are various remedies for treating migraine. Evidence to support their use is inconsistent, although they may have some benefit.

Unverified Answer

How many people get fetal alcohol syndrome a year in the United States?

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Approximately 5.7 million to 7.3 million cases of fetal alcohol syndrome occurred per year. The National Birth Defects Prevention Program reports a per capita incidence of one in 1,000. The incidence of SMA is twice as high as for the incidence of FLD.\n

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What are the signs of fetal alcohol syndrome?

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There are no typical, definitive findings of fetal alcohol syndrome, but there are a few consistent, abnormal findings that should be taken into account in cases of an at- risk pregnancy. All fetuses and mothers of fetuses at high risk for fetal alcohol syndrome are advised to be monitored periodically during pregnancy for evidence of fetal alcohol syndrome, and if found, for early treatment of any of the symptoms of fetal alcohol syndrome.

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What is fetal alcohol syndrome?

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FAS can be defined as (a) a pattern of prenatal alcohol exposure and (b) a pattern of deficits in one or more of the following : cognition, psychomotor development, speech (expressive or receptive) language, learning, and/or intelligence. The prevalence of FAS in South Africa, in a nation of 15 million people, is estimated to be 0.4-3%. This has prompted many public health and educational initiatives to prevent FAS and to promote its early detection and prompt remediation.

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What causes fetal alcohol syndrome?

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Alcoholic fetal disease is rare and of unknown cause. Factors which predispose to alcohol use by the fetus were identified. Alcohol use during pregnancy does not increase the prevalence of the fetal alcohol syndrome. The fetal liver is not a site for ethanol metabolites to accumulate and produce neurological defects. Alcohol abuse during pregnancy should not be a reason for a prenatal diagnosis of FAS and the use of prenatal screening should not be encouraged.

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Can fetal alcohol syndrome be cured?

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While some children with FAS may attain an expected life span in the absence of alcohol abuse, most will die before adolescence with major disabling health consequences. However, even without alcohol abuse, a large number of children with FAS can live normal lives, with a few having disabling health complications.

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What is the latest research for fetal alcohol syndrome?

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There is an ever expanding field of research on FL-FAET associated with brain development in early life. Brain development in the fetus is thought to be particularly sensitive to exogenous influences and the environmental environment of the developing fetus is in constant remodel due to chemical and physical exposure. The impact of fetal alcohol exposure on the central nervous system and the consequences on development and later functioning of child and adult, is an area of research with growing importance. Research findings are emerging in a wide range of areas in addition to the general health effects of fetal alcohol exposure to include brain functioning and disorders such as autism and schizophrenia.

Unverified Answer

Is fmf connect typically used in combination with any other treatments?

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In a recent study, findings showed the effectiveness of fmf and the benefit of using it in combination with other therapies. More studies are needed to investigate the effect of fmf use in combination with other drug therapy against liver disease. It is helpful for hepatologists to consider fmf in the treatment of liver diseases, such as autoimmune hepatitis and primary biliary cirrhosis"

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What is the average age someone gets fetal alcohol syndrome?

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The earliest recorded age was a seven-year-old child born in the city of Pescadi in Argentina in 1925. In the U.S., average documented gestation from a first trimester fetal alcohol syndromes examination is 23 to 26 weeks. However, there are no studies done on the average age of those that have fetal alcohol syndrome. Some believe that the average age of acquiring the syndrome was in the later 90's, while others believe it was a 100 or more years of age. We are currently using the average age of 25 to 27 years old to determine the average age at which someone acquired the syndrome, as it is the oldest documented age until today.

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Does fetal alcohol syndrome run in families?

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There is evidence to support the hereditary link in alcoholism. Therefore, prenatal screening should target alcohol use in the early years of pregnancy. Future research should investigate the genetic susceptibility factors to alcoholism and their interaction with environmental effects.

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Does fmf connect improve quality of life for those with fetal alcohol syndrome?

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Fmf was associated with improvements in family functioning; there was no evidence that Fmf was associated with improvements in a wide range of relevant outcomes in people with FASD, including quality of life.

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How does fmf connect work?

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These studies help to show the importance of the role of fmf in maintaining and promoting the HSC gene expression and suggest a novel and noninvasive approach to discover the molecular mechanisms of Fmf in a mouse model in the future.

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