Effects of Family Work Shop for Children With Developmental Delays

Developmental Delays Clinical Trial

Official title:

Effects of Family Work Shop for Children With Developmental Delays

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02523963
• Other study ID #: H10427
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 7, 2015
• Last updated: August 13, 2015
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2015
• Source: Taipei Medical University
• Contact: Ru-Lan h, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify the effects of family work shop for children with developmental delays.

Description:

Methods：

1. The family work shop has 5 courses, with 6 families in one course. 2. Intervention: 2-3 hours per session, one time per week, for a total of 6 weeks.

Effect：

1. Investigate the effects of family work shop for children with developmental delays, including health related quality of life, functional performance.

2. Investigate the effects of family care giver strain on family work shop for parents of children with developmental delays.

3. Investigate the differences of family impact between children with development delays and children with normal development.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

Inclusion Criteria:

• Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop

Exclusion Criteria:

• Failed to obtain written informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Developmental Delays

Intervention

Other:
• family work shop
The family work shop has 5 courses, with 6 families in one course. One course of intervention: 2-3 hours per session, one time per week, for a total of 6 sessions in 6 week periods

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	change in health related quality of life questionnaire	to identify the changes of health related quality of life of children after the workshop	baseline and 6 weeks	No