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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17244156

Enrollment

120

Registered

2018-06-12

Start date

2018-04-01

Completion date

Unknown

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Spectrum Disorder (FASD) Not Applicable

Interventions

There will be three groups recruited from Early Childhood Development (ECD) centers in the study area. There will be an intervention group of alcohol exposed children (40 participants), a control grou

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
NEPSY II psychometric assessment at baseline and post-intervention (roughly 6 months later)	—

Secondary

Measure	Time frame
Performance in game tracked by game logs post intervention	—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026