Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Overview

Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.

Full Title of Study: “Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With 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: June 30, 2023

Detailed Description

Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs. They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs. Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment. The evaluator will be blinded to the group's allocation during the whole course of the intervention.

Interventions

  • Other: Traditional rehabilitation programs with Individualized fairytales class
    • In addition to traditional rehabilitation programs, 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months, to preschool children with Attention Deficit Hyperactivity Disorder and developmental delays in regular traditional rehabilitation programs

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • traditional rehabilitation programs with additional individualized fairytales class
  • No Intervention: Control group
    • traditional rehabilitation programs without additional individualized fairytales class

Clinical Trial Outcome Measures

Primary Measures

  • changes of hyperactivity
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
  • changes of attention
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span

Secondary Measures

  • change of vocabulary
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance
  • change of sensory integration
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score change by Sensory Profile, 0-100, higher score indicating better sensory profile
  • change of intelligence
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score change by Wechsler Intelligence Scale for Children, the average score is 100, with a higher score indicating higher intelligence and a lower score indicating a lower level of intelligence
  • change of physical functional performance
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance
  • change of quality of life
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life
  • change of family impact
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance
  • change of walking time
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • walking time
  • change of stairs climbing time
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • climbing time
  • change of balance
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • one leg standing time
  • change of physical function
    • Time Frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
    • 5 times sit to stand up

Participating in This Clinical Trial

Inclusion Criteria

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

  • age less than 3 or greater than 6 of children diagnosed with Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ru-Lan Hsieh, MD, Principal Investigator, Shin Kong Wu Ho-Su Memorial Hospital
  • Overall Contact(s)
    • Ru-Lan Hsieh, MD, 886-2-28332211, M001052@ms.skh.org.tw

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