Effects of Attention Training on Children

Overview

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

Full Title of Study: “Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled. The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training. Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention. The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.

Interventions

  • Other: using interactive attention training system
    • using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder

Arms, Groups and Cohorts

  • Active Comparator: Study group
    • 3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
  • No Intervention: Control group
    • 3 months of conventional rehabilitation programs without interactive attention training programs

Clinical Trial Outcome Measures

Primary Measures

  • changes of symptoms of attention deficit hyperactivity disorder
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
    • score assessed by Swanson, Nolan and Pelham questionnaire

Secondary Measures

  • changes of sensory integration
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • score assessed by Sensory Profile
  • changes of visual motor integration
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • score assessed by Beery-Buktenica Visual Motor Integration Test
  • changes of intelligence
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • score assessed by Wechsler Intelligence Scale for Children
  • changes of functional performance
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • score assessed by Pediatric Outcome Data Collection Instrument
  • changes of health-related quality of life
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • score assessed by Pediatric Quality of Life Inventory
  • changes of family impact
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • Child Health Questionnaire, parent form 28
  • changes of walking speed
    • Time Frame: time change from baseline to 3 months of treatment, and 3 months after treatment
    • walking speed
  • changes of chair climbing speed
    • Time Frame: time change from baseline to 3 months of treatment, and 3 months after treatment
    • stairs climbing speed
  • changes of balance
    • Time Frame: time change from baseline to 3 months of treatment, and 3 months after treatment
    • one leg standing time
  • changes of coordination
    • Time Frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
    • Berg Balance Scale
  • changes of balance and coordination
    • Time Frame: time change from baseline to 3 months of treatment, and 3 months after treatment
    • timed up and go test
  • changes of physical performance
    • Time Frame: time change from baseline to 3 months of treatment, and 3 months after treatment
    • 5 time sit to stand test

Participating in This Clinical Trial

Inclusion Criteria

  • children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater Exclusion Criteria:

  • age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Taipei Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ru-Lan Hsieh, Principle investigator – Taipei Medical University
  • Overall Official(s)
    • Ru-Lan Ru-Lan, MD, Principal Investigator, Shin Kong Wu Ho-Su Memorial Hospital
  • Overall Contact(s)
    • Ru-Lan Hsieh, MD, 886228332211, M001052@ms.skh.org.tw

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