Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Overview

Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.

Full Title of Study: “Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2019

Detailed Description

A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled. The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training). Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively. Evaluator will be blinded to the group's classification during the whole course of study.

Interventions

  • Other: interactive cognitive training
    • Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay

Arms, Groups and Cohorts

  • Active Comparator: study group
    • 3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.
  • No Intervention: control group
    • 3 months of traditional rehabilitation programs, without individualized interactive cognitive training.

Clinical Trial Outcome Measures

Primary Measures

  • change of attention
    • Time Frame: scores change from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Swanson, Nolan and Pelham questionnaire

Secondary Measures

  • change of visual motor integration
    • Time Frame: scores change from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Beery-Buktenica Visual Motor Integration Test
  • change of sensory integration
    • Time Frame: scores change from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Sensory Profile questionnaire
  • change of intelligence
    • Time Frame: scores change from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Wechsler Intelligence Scale for Children, including verbal, performance and total scores, the average score is 100, with higher scores indicating higher than average intelligence and lower scores indicating lower levels of intelligence
  • change of functional performance
    • Time Frame: changes from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Pediatric Outcome Data Collection Instrument
  • change of health-related quality of life
    • Time Frame: changes from baseline to 3 months of treatment, and 3 months after treatment
    • score assessed by Pediatric Quality of Life Inventory-Generic Core Scales, including physical, psychosocial, and total scores, with higher scores representing better health-related quality of life

Participating in This Clinical Trial

Inclusion Criteria

  • children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater Exclusion Criteria:

  • age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular 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, Principal investigator – Taipei Medical University
  • Overall Official(s)
    • Ru-Lan Hsieh, 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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