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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

Not Applicable
Completed
Conditions
Fetal Alcohol Spectrum Disorder (FASD)
Not Applicable
Registration Number
ISRCTN17244156
Lead Sponsor
Foundation for Alcohol Related Research
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)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
116
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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