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Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Primary Purpose

Developmental Delay, Preschool Children, Attention Deficit Hyperactivity Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional rehabilitation programs with Individualized fairytales class
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Delay

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

traditional rehabilitation programs with additional individualized fairytales class

traditional rehabilitation programs without additional individualized fairytales class

Outcomes

Primary Outcome Measures

changes of hyperactivity
score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
changes of attention
score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span

Secondary Outcome Measures

change of vocabulary
score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance
change of sensory integration
score change by Sensory Profile, 0-100, higher score indicating better sensory profile
change of intelligence
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
score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance
change of quality of life
score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life
change of family impact
score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance
change of walking time
walking time
change of stairs climbing time
climbing time
change of balance
one leg standing time
change of physical function
5 times sit to stand up

Full Information

First Posted
August 14, 2022
Last Updated
August 14, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05502536
Brief Title
Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder
Official Title
Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Delay, Preschool Children, Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The participants and outcome assessor will be blinded to the groups' allocation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
traditional rehabilitation programs with additional individualized fairytales class
Arm Title
Control group
Arm Type
No Intervention
Arm Description
traditional rehabilitation programs without additional individualized fairytales class
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation programs with Individualized fairytales class
Intervention Description
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
Primary Outcome Measure Information:
Title
changes of hyperactivity
Description
score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
changes of attention
Description
score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary Outcome Measure Information:
Title
change of vocabulary
Description
score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of sensory integration
Description
score change by Sensory Profile, 0-100, higher score indicating better sensory profile
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of intelligence
Description
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
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of physical functional performance
Description
score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of quality of life
Description
score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of family impact
Description
score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of walking time
Description
walking time
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of stairs climbing time
Description
climbing time
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of balance
Description
one leg standing time
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Title
change of physical function
Description
5 times sit to stand up
Time Frame
score change from baseline to 12 weeks of treatment, and 12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2531
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

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