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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588391
• Other study ID #: 30874
• Secondary ID: K23HD071971
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 30, 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Brain Training (Active)
Online computer games targeting attention, EF, and problem-solving match the child's skill level.
• Brain Training (Passive)
Online computer games targeting attention, EF, and problem solving are set to a consistent level.
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on Executive Function Composite Measure at 2 months	EF composite measured post "Brain Training."	2 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Click here for more information about this study: Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment