Workshops for Toddlers With Speech and Language Developmental Delay

Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay

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

Study Overview

• Status: Completed
• Conditions: Developmental Delay
• Intervention / Treatment: Other: family workshop

Detailed Description

The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

1. Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
2. Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay

• Study Type: Interventional
• Enrollment (Actual): 122
• 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: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; family workshop	Other: family workshop; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peabody Developmental Motor Scales	assess fine motor function of children	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Outcomes Data Collection Instrument	measure the functional performance of children	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Child Health Questionnaire-Parent Form 28	assess the health status of children	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Quality of Life Inventory-Geriatric Core Scales	measure the quality of life of children	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Caregiver Strain Index	assess family strain	scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Impact on Family Scale	assess the effects of a child's illness of the function of the family system	scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Pediatric Quality of Life Inventory-Family Impact Module	assess the impact of pediatric conditions on family function and quality of life	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
World Health Organization Quality of Life Brief Version	evaluate parents' quality of life	scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Parental satisfaction questionnaire	assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction	after completion of 6 weeks of workshop
Emotional Competency Rating Scales	assess emotional function of children, higher scores mean a better outcome	scores change from baseline to 6 weeks after treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: family workshop
• Other Study ID Numbers: SKH-109

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