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Clinical Trials/ISRCTN17244156
ISRCTN17244156
Completed
未知

A randomised controlled trial of a custom-developed computer game to improve executive functioning in 4- to 6-year-old children exposed to alcohol in utero

Foundation for Alcohol Related Research0 sites116 target enrollmentJune 12, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Fetal Alcohol Spectrum Disorder (FASD)
Sponsor
Foundation for Alcohol Related Research
Enrollment
116
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31596247 (added 10/10/2019) 2020 non-peer-reviewed results in preprint https://preprints.jmir.org/preprint/20658 (added 10/06/2021)

Registry
who.int
Start Date
June 12, 2018
End Date
October 30, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Foundation for Alcohol Related Research

Eligibility Criteria

Inclusion Criteria

  • To be included in the intervention or control group particpants must be between 4 and 6 years old. There must also be documented exposure to alcohol in utero. Based on the maternal interview a mother must confirm using 3 or more standard units of alcohol at least once during pregnancy.
  • To be included in the normative group children must be between 4 and 6 years old, and there should no documented exposure to alcohol in utero.

Exclusion Criteria

  • Children with a physical disability which will hamper their interaction with the program will be excluded, for example severe problems with sight

Outcomes

Primary Outcomes

Not specified

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