Workshops for Children With Global Developmental Delays

Global Developmental Delay Clinical Trial

Official title:

Effects of Family Workshops on Children With Global Developmental Delays and Their Parents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05418933
• Other study ID #: SKH-111-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2022
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 101
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Global Developmental Delay

Intervention

Other:
• Family workshop
Family workshops for 5 courses, with 6-7 families in one course. The workshops were 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	Pediatric Outcome Data Collection Instrument	measure the functional performance of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment
Secondary	Mandarin-Chinese Communicative Developmental Inventory	assess communication function of children, <10% indicates delayed development, 10% or more than 10% indicates normal development	percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment
Secondary	Peabody Developmental Motor Scale	assess fine motor function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment
Secondary	Emotional Competency Rating Scale	assess the emotional function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment
Secondary	Pediatric Evaluation of Disability Inventory	assess the functional skill attainment of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment
Secondary	Pediatric Daily Occupation Scale	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	scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment
Secondary	Pediatric Quality of Life Inventory-Geriatric Core Scale	assess the quality of life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change ofPediatric Quality of Life Inventory-Geriatric Core Scale from baseline to 6 weeks after treatment
Secondary	Pediatric Quality of Life Inventory-Family Impact Module	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	scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment
Secondary	Parental satisfaction questionnaire	assess the parents' satisfaction with the workshops, with scores ranging from 1-to 100, higher scores mean a higher satisfaction	scores of Parental satisfaction questionnaire after treatment
Secondary	Caregiver Strain Index	assess family strain, the minimum and maximum values range from 1 to 100, higher scores mean a worse outcome	scores change of Caregiver Strain Index from baseline to 6 weeks after treatment