Effects of Educational Training on Children With Developmental Delay

NCT04988139 | Unknown

• 1 other identifier: 2021SKHADR032
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Delay

Keywords

preschool children; developmental delay; educational training; therapeutic effects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• change of 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 change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome

• Changes of functional performance

  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 change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome

• changes of family impact

  score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

traditional rehabilitation programs with additional individualized educational training

Other: individualized educational training

Control group

NO INTERVENTION

traditional rehabilitation programs without additional individualized educational training

Interventions

individualized educational training OTHER

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

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

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Ru-Lan Hsieh, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886228332211; M001052@ms.skh.org.tw

Ru-Lan Hsieh, MD

CONTACT

886228332211; rulan1052@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes measurements will be performed by researchers who are blind to the groups' allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 3, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)