Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05502536
• Other study ID #: 2022SKHADR033
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Developmental Delay
• Hyperkinesis
• Preschool Children

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