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Completed

NCT Number: NCT02588391

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline on Executive Function Composite Measure at 2 months

    Time frame: 2 months

    EF composite measured post "Brain Training."

Secondary outcomes

  1. Change from baseline on Executive Function Composite Measure at 5 months

    Time frame: 5 months

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

  2. Change from baseline on Executive Function Composite Measure at 8 months

    Time frame: 8 months

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

  3. Change from baseline on Early Academic Skills Measures at 8 months

    Time frame: 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

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

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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