Clinical trial NCT02588391: Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment
Official title: Randomized Controlled Trial of Executive Function Training in Preterm Children at Risk for Inattention, Hyperactivity and Executive Function Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: premature birth; executive function; preschool
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-10-27
Enrollment: 57
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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."

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline on Executive Function Composite Measure at 2 months
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline on Executive Function Composite Measure at 5 months
timeFrame: 5 months
measure: Change from baseline on Executive Function Composite Measure at 8 months
timeFrame: 8 months
measure: Change from baseline on Early Academic Skills Measures at 8 months
timeFrame: 8 months
measure: Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)
timeFrame: 2 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Irene M Loe, MD
role: PRINCIPAL_INVESTIGATOR
References: