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

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Training (Active)
Brain Training (Passive)
Brain Training (Active or Passive)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring premature birth; executive function; preschool

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Active Brain Training

Passive Brain Training

Cross-over

Arm Description

The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.

The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent skill level.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline on Executive Function Composite Measure at 5 months
EF composite measured 3-months post "Brain Training" and 5 months from baseline
Change from baseline on Executive Function Composite Measure at 8 months
EF composite measured 6-months post "Brain Training" and 8 months from baseline
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
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"

Full Information

First Posted
October 26, 2015
Last Updated
August 2, 2019
Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02588391
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
premature birth; executive function; preschool

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Brain Training
Arm Type
Experimental
Arm Description
The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.
Arm Title
Passive Brain Training
Arm Type
Experimental
Arm Description
The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent skill level.
Arm Title
Cross-over
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brain Training (Active)
Intervention Description
Online computer games targeting attention, EF, and problem-solving match the child's skill level.
Intervention Type
Behavioral
Intervention Name(s)
Brain Training (Passive)
Intervention Description
Online computer games targeting attention, EF, and problem solving are set to a consistent level.
Intervention Type
Behavioral
Intervention Name(s)
Brain Training (Active or Passive)
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline on Executive Function Composite Measure at 2 months
Description
EF composite measured post "Brain Training."
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from baseline on Executive Function Composite Measure at 5 months
Description
EF composite measured 3-months post "Brain Training" and 5 months from baseline
Time Frame
5 months
Title
Change from baseline on Executive Function Composite Measure at 8 months
Description
EF composite measured 6-months post "Brain Training" and 8 months from baseline
Time Frame
8 months
Title
Change from baseline on Early Academic Skills Measures at 8 months
Description
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
Title
Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)
Description
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"
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene M Loe, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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