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

Not Applicable

Completed

Interventions: Behavioral: Brain Training (Active)
Behavioral: Brain Training (Passive)
Behavioral: Brain Training (Active or Passive)

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."

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Active Brain Training	Brain Training (Active)	The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.
Passive Brain Training	Brain Training (Passive)	The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent skill level.
Cross-over	Brain Training (Active or Passive)	Following completion of the 6-month follow-up sessions after completion of "Brain Training", each group is allowed to cross-over to the other arm of "Brain Training" (open-label extension).

Primary Outcome Measures

Name	Time	Method
Change from baseline on Executive Function Composite Measure at 2 months	2 months	EF composite measured post "Brain Training."

Secondary Outcome Measures

Name	Time	Method
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 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"
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 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

Locations (1): Stanford University School of Medicine
🇺🇸
Stanford, California, United States