Effects of Educational Training on Children With Developmental Delay

Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay

Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.

Study Overview

• Status: Not yet recruiting
• Conditions: Developmental Delay
• Intervention / Treatment: Other: individualized educational training

Detailed Description

A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.

The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).

Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.

The evaluators will be blinded to the group's allocation during the whole course of the intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 886228332211; Email: M001052@ms.skh.org.tw
• Study Contact Backup: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 886228332211; Email: rulan1052@tmu.edu.tw

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 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 developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; traditional rehabilitation programs with additional individualized educational training	Other: individualized educational training; 50 min per session, one session per week, 4 sessions per month, of individualized educational training to preschool children with developmental delays under traditional rehabilitation programs
No Intervention: Control group; traditional rehabilitation programs without additional individualized educational training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of daily activity	score assessed by Pediatric Daily Occupation Scale	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of attention	score assessed by Conners Kiddie Continous Performance Test, 2nd edition	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of visual motor integration	score assessed by Beery-Buktenica Visual Motor Integration	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
change of intelligence	score assessed by Wechsler Intelligence Scale of children	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Changes of functional performance	score assessed by Pediatric Outcome Data Collection Instrument	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of quality of life	score assessed by Pediatric Quality of Life Inventory	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact	score assessed by Child Health Questionnaire, parent form 28	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed	walking speed	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of chair climbing speed	stairs climbing speed	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance	one leg standing time	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination	timed up and go test	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of physical function	5 times sit to stand test	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: preschool children; developmental delay; educational training; therapeutic effects
• Other Study ID Numbers: 2021SKHADR032

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
• product manufactured in and exported from the U.S.: No