Workshops for Toddlers With Speech and Language Developmental Delay

Developmental Delay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413630
• Other study ID #: SKH-109
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2020
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay

Intervention

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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Caregiver Strain Index	assess family strain	scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Emotional Competency Rating Scales	assess emotional function of children, higher scores mean a better outcome	scores change from baseline to 6 weeks after treatment