Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

NCT05502536 | Unknown

• 1 other identifier: 2022SKHADR033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Developmental Delay; Preschool Children; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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 physical functional performance

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

traditional rehabilitation programs with additional individualized fairytales class

Other: Traditional rehabilitation programs with Individualized fairytales class

Control group

NO INTERVENTION

traditional rehabilitation programs without additional individualized fairytales class

Interventions

Traditional rehabilitation programs with Individualized fairytales class OTHER

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

Intervention group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preschool children with a diagnosis of Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Learning Disabilities; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Ru-Lan Hsieh, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886-2-28332211; M001052@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcome assessor will be blinded to the groups' allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: August 20, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)