- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359591
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
January 22, 2018 updated by: Hsin-Yi Kathy Cheng
【Background& Purpose】In order to early detect the problems a child might have during his/her development, an effective screening tool is of great needs.
The [Taipei City Child Development Screening checklist] is often used to serve this process.
This text version is mainly distributed to the parents to fill out during their child regular check-ups to the hospitals and clinics.
The drawbacks of this checklist is that it lacks of active participation of the target population, and the text version limits its usage to people who are not familiar with Chinese characteristics, such as those new inhabitant.
These lead to low screening rates therefore causing delayed early intervention.
【Purpose】The purpose of this study was to design and develop the multi-media graphic version of the [Taipei City Child Development Screening checklist] based on its original text version.【Method】The
developed muti-media system will be checked for is validity.
Thirty parents/legal guardians of children in each target age groups will be recruited randomly for the clinical reliability evaluation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
390
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taoyuan, Taiwan, 333
- Chang Gung Univ.
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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 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
guardians whose child is between 3 months and 7 years old
Description
Inclusion Criteria:
- For parents/primary caregivers whose children are between 3 months and 7 years old can participate.
Exclusion Criteria:
- Any visual impairment.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
text-based or multimedia
Subject fills in a questionnaire regarding whether the child meets developmental milestones for his/her developmental age, both the text-based and the multimedia version.
A total score will be calculated and compared.
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subjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
13 developmental milestones questionnaire
Time Frame: baseline
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there will be 13 developmental milestones in each age range.
The guardian of each subject check "yes/no" depends on whether his/her child reaches the milestone
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chang Gung Medical Hospital Chang Gung Medical Hospital, Chang Gung Medical Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Actual)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- ChangGungMH (Other Identifier: ChangGungMH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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