Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Study Overview
=================
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.

Official Title
-----------------
Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay

Conditions
-----------------
Developmental Delay, Preschool Children, Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Other: Traditional rehabilitation programs with Individualized fairytales class


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>traditional rehabilitation programs with additional individualized fairytales class | Other: Traditional rehabilitation programs with Individualized fairytales class<br>* 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<br>|
| No Intervention: Control group<br>traditional rehabilitation programs without additional individualized fairytales class | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of vocabulary | score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of sensory integration | score change by Sensory Profile, 0-100, higher score indicating better sensory profile | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| 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 | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of physical functional performance | score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| 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 | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of family impact | score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of walking time | walking time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of stairs climbing time | climbing time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of balance | one leg standing time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 
| change of physical function | 5 times sit to stand up | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |