Workshops for Toddlers With Speech and Language Developmental Delay

NCT04413630 | Completed

• 1 other identifier: SKH-109
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family

Conditions

Developmental Delay

Keywords

family workshop

Outcome Measures

Primary Outcomes (1)

• Chinese Communicative Developmental Inventory

  assess communication and language function of children

  scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

Secondary Outcomes (10)

• Peabody Developmental Motor Scales

  scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

• Pediatric Outcomes Data Collection Instrument

  scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

• Child Health Questionnaire-Parent Form 28

  scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

• Pediatric Quality of Life Inventory-Geriatric Core Scales

  scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

• Caregiver Strain Index

  scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome

Study Arms (1)

Study group

EXPERIMENTAL

family workshop

Other: family workshop

Interventions

family workshop OTHER

The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks

Study group

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function
• the availability of toddlers and their parents to attend one 2-hour session of the workshop per week for 6 weeks

You may not qualify if:

• Less than 18 months old or older than 36 months old

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)