Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Attention Deficit Hyperactivity Disorder; Developmental Delay; Preschool Children
• Intervention / Treatment: Other: Traditional rehabilitation programs with Individualized fairytales class

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; traditional rehabilitation programs with additional individualized fairytales class	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
NO_INTERVENTION: Control group; 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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 20, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (ACTUAL): August 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 2022SKHADR033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No