Clinical trial NCT04413630: Workshops for Toddlers With Speech and Language Developmental Delay
Official title: Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Keywords: family workshop
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Chinese Communicative Developmental Inventory
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Secondary outcomes:
measure: Peabody Developmental Motor Scales
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: Pediatric Outcomes Data Collection Instrument
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: Child Health Questionnaire-Parent Form 28
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: Pediatric Quality of Life Inventory-Geriatric Core Scales
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: Caregiver Strain Index
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
measure: Impact on Family Scale
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
measure: Pediatric Quality of Life Inventory-Family Impact Module
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: World Health Organization Quality of Life Brief Version
timeFrame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
measure: Parental satisfaction questionnaire
timeFrame: after completion of 6 weeks of workshop
measure: Emotional Competency Rating Scales
timeFrame: scores change from baseline to 6 weeks after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: