Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment

NCT02588365 | Completed DMC

• 1 other identifier: 30874-2
• Study Type: interventional
• Target: 34
• 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 with or at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. 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

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; executive function; preschool

Outcome Measures

Primary Outcomes (1)

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

  EF composite measured post "Brain Training"

  2 months

Secondary Outcomes (2)

• 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

Study Arms (3)

Brain Training (Active)

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)

Brain Training (Passive)

EXPERIMENTAL

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

Behavioral: Brain Training (Passive)

Cross-over

EXPERIMENTAL

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

Brain Training (Active)

Brain Training (Passive) BEHAVIORAL

Online computer games targeting attention, EF, and problem solving

Brain Training (Passive)

Brain Training (Active or Passive) BEHAVIORAL

Online computer games targeting attention, EF, and problem solving

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 Full term (37 weeks gestation or greater)
• Diagnosis of ADHD or high ADHD symptoms (T-score 60 or greater on standardized behavior questionnaire)
• Able to comprehend task instructions

You may not qualify if:

• Major neurosensory impairment (ie blind, deaf) that interferes with testing
• Genetic syndrome
• Inability to comprehend task instructions

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

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)