- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523963
Effects of Family Work Shop for Children With Developmental Delays
August 13, 2015 updated by: Ru-Lan Hsieh, Taipei Medical University
The purpose of this study is to identify the effects of family work shop for children with developmental delays.
Study Overview
Detailed 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:
- Investigate the effects of family work shop for children with developmental delays, including health related quality of life, functional performance.
- Investigate the effects of family care giver strain on family work shop for parents of children with developmental delays.
- Investigate the differences of family impact between children with development delays and children with normal development.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ru-Lan h, MD
- Phone Number: 2538 886-2-28332211
- Email: M001052@ms.skh.org.tw
Study Locations
-
-
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
children with developmental delays participated 6 sessions of family work shop
|
|
No Intervention: control
children with normal development not participate the work shop followed up at before, and 6 weeks later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in health related quality of life questionnaire
Time Frame: baseline and 6 weeks
|
to identify the changes of health related quality of life of children after the workshop
|
baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ru-Lan Hsieh, MD, visiting staff of Shin Kong Wu Ho-Su Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
August 7, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Estimate)
August 14, 2015
Last Update Submitted That Met QC Criteria
August 13, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H10427
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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