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

NCT ID: NCT02588391

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-12-30

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."

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Brain Training

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

Group Type: EXPERIMENTAL

Brain Training (Active)

Intervention Type: BEHAVIORAL

Online computer games targeting attention, EF, and problem-solving match the child's skill level.

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.

Group Type: EXPERIMENTAL

Brain Training (Passive)

Intervention Type: BEHAVIORAL

Online computer games targeting attention, EF, and problem solving are set to a consistent level.

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).

Group Type: OTHER

Brain Training (Active or Passive)

Intervention Type: 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.

Interventions

Brain Training (Active)

Online computer games targeting attention, EF, and problem-solving match the child's skill level.

Intervention Type: BEHAVIORAL

Brain Training (Passive)

Online computer games targeting attention, EF, and problem solving are set to a consistent level.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Irene M. Loe, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene M Loe, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

K23HD071971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

30874

Identifier Type: -

Identifier Source: org_study_id