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

Randomized Controlled Trial of Executive Function 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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Brain Training (Active); Behavioral: Brain Training (Passive); Behavioral: Brain Training (Active or Passive)

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."

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Brain Training; 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); Online computer games targeting attention, EF, and problem-solving match the child's skill level.
Experimental: Passive Brain Training; 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); Online computer games targeting attention, EF, and problem solving are set to a consistent level.
Other: Cross-over; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: premature birth; executive function; preschool
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 30874; K23HD071971 (U.S. NIH Grant/Contract)