Clinical trial NCT05418933: Workshops for Children With Global Developmental Delays
Official title: Effects of Family Workshops on Children With Global Developmental Delays and Their Parents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Global Developmental Delay
Keywords: family workshops
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 101
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: TREATMENT

Brief summary: To investigate the therapeutic effects of family workshops on children with global developmental delays and their parents by the analysis of the previously conducted workshops.

Detailed description: To evaluate the effects of family workshops for children aged 18-36 months old with language developmental delays conducted from Jan 2014 Jan to Dec 2018, by the data analysis.

The participants were children with global developmental delay (language delay with at least one delay in motor, cognitive function, or emotional and social functioning) and their parents in the workshops.

The family workshops were conducted with 5 courses, with 6-7 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

1. Investigate the therapeutic effects of workshops for children with global developmental delays
2. Investigate the therapeutic effects of workshops for the parents of children with global developmental delays

Eligibility criteria: Inclusion Criteria:

* Children aged 18-36 months old with global developmental delays (language developmental delay, with motor, cognition, or social and emotional developmental delays) Parents and children attended the one 2 hour-session of workshop per week for 6 weeks

Exclusion Criteria:

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

Primary outcomes:
measure: Pediatric Outcome Data Collection Instrument
timeFrame: scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment
Secondary outcomes:
measure: Mandarin-Chinese Communicative Developmental Inventory
timeFrame: percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment
measure: Peabody Developmental Motor Scale
timeFrame: scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment
measure: Emotional Competency Rating Scale
timeFrame: scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment
measure: Pediatric Evaluation of Disability Inventory
timeFrame: scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment
measure: Pediatric Daily Occupation Scale
timeFrame: scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment
measure: Pediatric Quality of Life Inventory-Geriatric Core Scale
timeFrame: scores change ofPediatric Quality of Life Inventory-Geriatric Core Scale from baseline to 6 weeks after treatment
measure: Pediatric Quality of Life Inventory-Family Impact Module
timeFrame: scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment
measure: Parental satisfaction questionnaire
timeFrame: scores of Parental satisfaction questionnaire after treatment
measure: Caregiver Strain Index
timeFrame: scores change of Caregiver Strain Index 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: Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: