Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment

Stanford University57 enrolled

Overview

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: * 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."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Interventions

Brain Training (Active)BEHAVIORAL

Online computer games targeting attention, EF, and problem-solving match the child's skill level.

Brain Training (Passive)BEHAVIORAL

Online computer games targeting attention, EF, and problem solving are set to a consistent level.

Brain Training (Active or Passive)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline on Executive Function Composite Measure at 2 months

EF composite measured post "Brain Training."

Time frame: 2 months

Secondary Outcomes

Change from baseline on Executive Function Composite Measure at 5 months

EF composite measured 3-months post "Brain Training" and 5 months from baseline

Time frame: 5 months

Change from baseline on Executive Function Composite Measure at 8 months

EF composite measured 6-months post "Brain Training" and 8 months from baseline

Time frame: 8 months

Change from baseline on Early Academic Skills Measures at 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

Time frame: 8 months

Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)

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"