Effects of Educational Training on Children With Developmental Delay

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Developmental Delay

Intervention / Treatment
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* Other: individualized educational training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 20 children with developmental delays 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 additional educational training) and the control group (traditional rehabilitation program without educational training). The intervention group will receive 1 month of individualized educational training, 50 min per session, 1 session per week, a total of 4 sessions. All of the evaluations will be performed before training, re-evaluated 1 month after completion of treatment, and 3 months after completion of the treatment in the study group. The control group will be evaluated at the baseline, 1 month, and 6 months later, respectively.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>traditional rehabilitation programs with additional individualized educational training | Other: individualized educational training<br>* 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<br>|
| No Intervention: Control group<br>traditional rehabilitation programs without additional individualized educational training | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preschool children, developmental delay, educational training, therapeutic effects