Workshops for Children With Global Developmental Delays

Not Applicable

• Conditions: Global Developmental Delay
• Interventions: Other: Family workshop

• Registration Number: NCT05418933
• Lead Sponsor: Taipei Medical University

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

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study Start: 2022-06-10
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Family workshop	Family workshops with 5 courses, with 6-7 families in one course, 2 hours per session, one time per week, for a total of 6 weeks.

Primary Outcome Measures

Name	Time	Method
Pediatric Outcome Data Collection Instrument	scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment	measure the functional performance of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Peabody Developmental Motor Scale	scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment	assess fine motor function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
Pediatric Daily Occupation Scale	scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment	assess the occupational performance in the daily life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
Pediatric Quality of Life Inventory-Geriatric Core Scale	scores change ofPediatric Quality of Life Inventory-Geriatric Core Scale from baseline to 6 weeks after treatment	assess the quality of life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
Pediatric Quality of Life Inventory-Family Impact Module	scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment	assess the impact of pediatric conditions on family functioning and parental quality of life, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
Caregiver Strain Index	scores change of Caregiver Strain Index from baseline to 6 weeks after treatment	assess family strain, the minimum and maximum values range from 1 to 100, higher scores mean a worse outcome
Emotional Competency Rating Scale	scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment	assess the emotional function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
Mandarin-Chinese Communicative Developmental Inventory	percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment	assess communication function of children, \<10% indicates delayed development, 10% or more than 10% indicates normal development
Parental satisfaction questionnaire	scores of Parental satisfaction questionnaire after treatment	assess the parents' satisfaction with the workshops, with scores ranging from 1-to 100, higher scores mean a higher satisfaction
Pediatric Evaluation of Disability Inventory	scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment	assess the functional skill attainment of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan