Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05502536
Collaborator
(none)
30
1
2
10.3
2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Traditional rehabilitation programs with Individualized fairytales class
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The participants and outcome assessor will be blinded to the groups' allocation.
Primary Purpose:
Treatment
Official Title:
Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay
Anticipated Study Start Date :
Aug 20, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

traditional rehabilitation programs with additional individualized fairytales class

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

No Intervention: Control group

traditional rehabilitation programs without additional individualized fairytales class

Outcome Measures

Primary Outcome Measures

  1. changes of hyperactivity [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

  2. changes of attention [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 Outcome Measures

  1. change of vocabulary [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

  2. change of sensory integration [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

  3. change of intelligence [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

  4. change of physical functional performance [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

  5. change of quality of life [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

  6. change of family impact [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

  7. change of walking time [score change from baseline to 12 weeks of treatment, and 12 weeks after treatment]

    walking time

  8. change of stairs climbing time [score change from baseline to 12 weeks of treatment, and 12 weeks after treatment]

    climbing time

  9. change of balance [score change from baseline to 12 weeks of treatment, and 12 weeks after treatment]

    one leg standing time

  10. change of physical function [score change from baseline to 12 weeks of treatment, and 12 weeks after treatment]

    5 times sit to stand up

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111-01

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05502536
Other Study ID Numbers:
  • 2022SKHADR033
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022