Premature Birth
Conditions
Keywords
premature birth; executive function; preschool
Brief summary
The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games (brain training) targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk for EF problems due to premature birth. The investigators hypothesize that children receiving active brain training will show greater improvements in EF and related skills immediately after treatment than children receiving passive brain training. The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.
Detailed description
Detailed description: * Investigators will talk to you by telephone to determine if your child might be eligible for the study. * Children complete two baseline testing sessions to evaluate executive function (EF) and related skills * Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills. * After completion of the baseline testing, we will inform you of eligibility for the Brain Training phase. * During Brain Training children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions. * Children return for 3 more time points, immediately after the completion of Brain Training (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of Brain Training.
Interventions
BEHAVIORALBrain Training (Active)
Online computer games targeting attention, EF, and problem-solving match the child's skill level.
BEHAVIORALBrain Training (Passive)
Online computer games targeting attention, EF, and problem solving are set to a consistent level.
BEHAVIORALBrain Training (Active or Passive)
Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 4 or 5 years * Born prematurely at \<33 weeks gestation * Able to comprehend task instructions * EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)
Exclusion criteria
* Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing * Genetic syndrome * Inability to comprehend task instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on Executive Function Composite Measure at 2 months | 2 months | EF composite measured post Brain Training. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on Executive Function Composite Measure at 5 months | 5 months | EF composite measured 3-months post Brain Training and 5 months from baseline |
| Change from baseline on Executive Function Composite Measure at 8 months | 8 months | EF composite measured 6-months post Brain Training and 8 months from baseline |
| Change from baseline on Early Academic Skills Measures at 8 months | 8 months | Composite scores from standardized measures of pre-academic skills and early literacy and numeracy measures at 6-months post Brain Training and 8 months from baseline |
| Change from 8-month Executive Function Composite Measure at 10 months (cross over groups) | 2 months | Children who cross-over to the other Brain Training intervention arm after the 8 month follow-up visit, will be re-assessed at the completion of the alternate version of Brain Training |
Countries
United States
Outcome results
None listed