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Clinical Trials/NCT05502536
NCT05502536
Unknown
Not Applicable

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

Taipei Medical University1 site in 1 country30 target enrollmentAugust 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Developmental Delay
Sponsor
Taipei Medical University
Enrollment
30
Locations
1
Primary Endpoint
changes of hyperactivity
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2022
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

changes of hyperactivity

Time Frame: 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

changes of attention

Time Frame: 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 Outcomes

  • change of physical functional performance(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of walking time(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of vocabulary(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of sensory integration(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of intelligence(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of quality of life(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of family impact(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of stairs climbing time(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of balance(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
  • change of physical function(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)

Study Sites (1)

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