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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05502536
Other study ID # 2022SKHADR033
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date June 30, 2023

Study information

Verified date August 2022
Source Taipei Medical University
Contact Ru-Lan Hsieh, MD
Phone 886-2-28332211
Email M001052@ms.skh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Shin Kong Wu Ho-Su Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary change of walking time walking time score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary change of stairs climbing time climbing time score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary change of balance one leg standing time score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary change of physical function 5 times sit to stand up score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
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