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
| ISRCTN | ISRCTN17244156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17244156 |
| Secondary identifying numbers | N16/05/063 |
- Submission date
- 31/05/2018
- Registration date
- 12/06/2018
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Current plain English summary as of 26/03/2019:
Background and study aims
Alcohol exposure during pregnancy negatively affects a baby's brain development. It can also lead to Fetal Alcohol Spectrum Disorders (FASD). The aim of this study is to see if it is possible to improve the brain development of children exposed to alcohol by using a computer game specifically designed to do this.
Who can participate?
Children between 4 and 6 years old who were exposed to alcohol during pregnancy, and a group of unexposed children
What does the study involve?
Alcohol-exposed children are randomly allocated to one of two groups. One group of children are given the opportunity to play the game twice a week for 6 months. The other group and the unexposed children receive no intervention. All participants receive psychological assessments.
What are the possible benefits and risks of participating?
Children in the intervention group may improve their brain functioning over the course of the intervention. They also receive two psychological assessments, and the results are shared with their parents to help them assist the child with any identified problems. The other two groups also receive the assessments and their parents also receive the information. They do not directly benefit from the intervention however. No significant risks are expected. There is a risk of stigmatisation of the mothers and children in an already marginalised/vulnerable population. The inclusion criteria are kept confidential to ensure no one outside of the study will be able to identify which participants were exposed to alcohol.
Where is the study run from?
FARR West Coast (South Africa)
When is the study starting and how long is it expected to run for?
February 2018 to October 2019
Who is funding the study?
The study is being funded by the Aware.org, a registered non-profit organisation in South Africa
Who is the main contact?
Mr Jaco Louw
Previous plain English summary:
Background and study aims
Alcohol exposure during pregnancy negatively affects a baby's brain development. It can also lead to Fetal Alcohol Spectrum Disorders (FASD). The aim of this study is to see if it is possible to improve the brain development of children exposed to alcohol by using a computer game specifically designed to do this.
Who can participate?
Children between 4 and 6 years old who were exposed to alcohol during pregnancy, and a group of unexposed children
What does the study involve?
Alcohol-exposed children are randomly allocated to one of two groups. One group of children are given the opportunity to play the game twice a week for 6 months. The other group and the unexposed children receive no intervention. All participants receive psychological assessments.
What are the possible benefits and risks of participating?
Children in the intervention group may improve their brain functioning over the course of the intervention. They also receive two psychological assessments, and the results are shared with their parents to help them assist the child with any identified problems. The other two groups also receive the assessments and their parents also receive the information. They do not directly benefit from the intervention however. No significant risks are expected. There is a risk of stigmatisation of the mothers and children in an already marginalised/vulnerable population. The inclusion criteria are kept confidential to ensure no one outside of the study will be able to identify which participants were exposed to alcohol.
Where is the study run from?
FARR West Coast (South Africa)
When is the study starting and how long is it expected to run for?
February 2018 to October 2018
Who is funding the study?
The study is being funded by the Aware.org, a registered non-profit organisation in South Africa
Who is the main contact?
Mr Jaco Louw
Contact information
Scientific
42 Bloemhof Road
Belville
Cape Town
7535
South Africa
 ORCID ID |
0000-0001-7812-2524 |
|---|
Study information
| Study design | Single-center randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study objectives | Primary: 1. At baseline alcohol exposed children (both intervention and control groups) will perform significantly worse on psychometric assessments than unexposed children 2. Post intervention the Intervention group will score higher on psychometric assessment domains than the control group, but lower than the normative group 3. Post intervention the Intervention group will show greater improvement in psychometric assessment domains than the control and intervention groups Secondary: 1. Improvement in game performance will be correlated with improvement in psychometric assessment scores |
| Ethics approval(s) | Health Research Ethics Committee at Stellenbosch University, 18/08/2016, ref: N16/05/063 |
| Health condition(s) or problem(s) studied | Fetal Alcohol Spectrum Disorder (FASD) |
| Intervention | 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 group of alcohol exposed children (40 participants) and a group of unexposed children to provide normative data (40 participants). The alcohol exposed children will be identified through maternal interviews with the mothers of children in the ECD centers. If alcohol use during pregnancy is confirmed they will be allocated to either the control group or the intervention group using block randomization. Sampling will continue until 40 participants have been randomized into each group. After these groups have been filled 40 participants will be randomly selected from the non-alcohol exposed children to make up a normative group. All three groups will receive baseline assessments looking at cognitive function. The intervention group will play a custom developed computer game 2 times a week for six months. The game has been designed to tax executive functions and improve them through training. The game sessions will be overseen by a community worker and will take place at the ECD centers the participants were recruited from. There will be no intervention/treatment given to the control and normative groups. All three groups will receive post-intervention assessments. |
| Intervention type | Other |
| Primary outcome measure | NEPSY II psychometric assessment at baseline and post-intervention (roughly 6 months later) |
| Secondary outcome measures | Performance in game tracked by game logs post intervention |
| Overall study start date | 01/02/2018 |
| Completion date | 30/10/2019 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | Total of 120 children: intervention group 40; control group 40; normative group 40 |
| Total final enrolment | 116 |
| Key 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. |
| Key exclusion criteria | Children with a physical disability which will hamper their interaction with the program will be excluded, for example severe problems with sight |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 09/11/2018 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Vredenburg
7380
South Africa
Sponsor information
Research organisation
42 Bloemhof Road
Belville
Cape Town
7535
South Africa
| Phone | +27 (0)216862646 |
|---|---|
| info@farrsa.org.za | |
| Website | www.farrsa.org.za |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Effectiveness of a custom developed computer game to improve executive functioning in 4 to 6-year-old children exposed to alcohol in utero: Study protocol for a randomised control trial. This article will be submitted to the journal Trials by October 2018 2. Maternal risk factors for alcohol exposed pregnancies in a South African community. This article will be submitted to the journal Alcoholism Clinical and Experimental Research by October 2019 3. Executive functioning in prenatally alcohol exposed children in a South African population. This article will be submitted to the journal Child Neuropsychology by October 2019 4. Comparing performance in a cognitive training game to NEPSY II scores in children with FASD. This article will be submitted to Games for Health by October 2019 5. Computer based cognitive training programme for FASD. Comparing pre and post intervention NEPSY II scores of prenatally alcohol exposed children. This article will be submitted to Child Neuropsychology by October 2019 6. Performance of prenatally alcohol exposed children in a cognitive training game: A factor analysis. This article will be submitted to the journal Games for Health by October 2019 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/10/2019 | 10/10/2019 | Yes | No |
| Preprint results | non-peer-reviewed results | 16/03/2021 | 10/06/2021 | No | No |
Editorial Notes
10/06/2021: Preprint publication reference added.
09/11/2020: Total final enrolment number added. The intention to publish date was changed from 01/10/2019 to 01/04/2021.
10/10/2019: Publication reference added.
26/03/2019: The following changes were made:
1. The overall trial end date was updated from 01/03/2019 to 30/10/2019.
2. The plain English summary was updated.
22/10/2018: The recruitment end date has been changed from 30/09/2018 to 09/11/2018
27/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/08/2018 to 30/09/2018.
2. The overall trial end date was changed from 01/02/2019 to 01/03/2019.
08/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 15/08/2018.
2. The overall trial end date was changed from 31/10/2018 to 01/02/2019.
