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

NCT02588391 | Completed DMC

• 2 other identifiers: 30874K23HD071971
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

premature birth; executive function; preschool

Outcome Measures

Primary Outcomes (1)

• Change from baseline on Executive Function Composite Measure at 2 months

  EF composite measured post "Brain Training."

  2 months

Secondary Outcomes (4)

• Change from baseline on Executive Function Composite Measure at 5 months

  5 months

• Change from baseline on Executive Function Composite Measure at 8 months

  8 months

• Change from baseline on Early Academic Skills Measures at 8 months

  8 months

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

  2 months

Study Arms (3)

Active Brain Training

EXPERIMENTAL

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)

Passive Brain Training

EXPERIMENTAL

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)

Cross-over

OTHER

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)

Interventions

Brain Training (Active) BEHAVIORAL

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

Active Brain Training

Brain Training (Passive) BEHAVIORAL

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

Passive Brain Training

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.

Cross-over

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Irene M Loe, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 30, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

US (1)