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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Executive Function Training in Preterm Children at Risk for Inattention, Hyperactivity and Executive Function Impairment

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: Brain Training (Active)
* Behavioral: Brain Training (Passive)
* Behavioral: Brain Training (Active or Passive)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Brain Training<br>The children in this arm receive one type of Brain Training with online computer games that actively matches their skill level. | Behavioral: Brain Training (Active)<br>* Online computer games targeting attention, EF, and problem-solving match the child's skill level.<br>|
| Experimental: Passive Brain Training<br>The children in this arm receive one type of Brain Training with online computer games that are at a consistent skill level. | Behavioral: Brain Training (Passive)<br>* Online computer games targeting attention, EF, and problem solving are set to a consistent level.<br>|
| Other: Cross-over<br>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). | Behavioral: Brain Training (Active or Passive)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Executive Function Composite Measure at 2 months | EF composite measured post Brain Training. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Executive Function Composite Measure at 5 months | EF composite measured 3-months post Brain Training and 5 months from baseline | 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 | 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 | 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature birth; executive function; preschool