Child Development ChecklistNCT02359591
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
An observational study of Child Development Checklist, run by Hsin-Yi Kathy Cheng at 1 site in Taiwan.
Trial summary
【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. Read more about this study
- Who is it for?
- Ages 20 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development Checklist
- What is being tested?
- text-based or multimedia
- How many people
- 390 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: guardians whose child is between 3 months and 7 years old
Who may be able to join
- For parents/primary caregivers whose children are between 3 months and 7 years old can participate.
Who cannot join
- Any visual impairment.
Trial locations and contacts
1 site in 1 country.
About this study
【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.
- Conditions
- Child Development Checklist
- Being tested
- text-based or multimedia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text-based or multimediaOther
subjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: text-based or multimedia |
What is being measured
The primary outcome is the main question the study is designed to answer.
13 developmental milestones questionnaire
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Development ChecklistStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hsin-Yi Kathy Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hsin-Yi Kathy Cheng, Chang Gung Memorial Hospital
- Investigators
- Chang Gung Medical Hospital Chang Gung Medical Hospital, Study director, Chang Gung Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359591
- Sponsor's protocol ID
- ChangGungMH
- Status last verified
- Jan 2018
- First submitted
- 5 Nov 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
Publications
Cheng HK, Chen LY, Cheng CH, Ju YY, Chen CL, Tseng KC. A Multimedia Child Developmental Screening Checklist: Design and Validation. J Med Internet Res. 2016 Oct 24;18(10):e277. doi: 10.2196/jmir.6249.
PubMed 27777218
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
- ClinicalTrials.gov ID
- NCT02359591
- Acronym / sponsor ID
- ChangGungMH
- Conditions
- Child Development Checklist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Hsin-Yi Kathy ChengUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
【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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| text-based or multimedia | – | Other: text-based or multimediaSubject 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. |
Who may qualify
- Ages
- 20 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- guardians whose child is between 3 months and 7 years old
Key inclusion criteria (1 listed)
- For parents/primary caregivers whose children are between 3 months and 7 years old can participate.
Key exclusion criteria (1 listed)
- Any visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text-based or multimediasubjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age. | Other | text-based or multimedia |
Primary outcome
13 developmental milestones questionnaire
Time frame: baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Derived from this study: PubMed 27777218Cheng HK, Chen LY, Cheng CH, Ju YY, Chen CL, Tseng KC. A Multimedia Child Developmental Screening Checklist: Design and Validation. J Med Internet Res. 2016 Oct 24;18(10):e277. doi: 10.2196/jmir.6249.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Gung Medical Hospital Chang Gung Medical Hospital study director
Chang Gung Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Checklist, run by Hsin-Yi Kathy Cheng at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13 developmental milestones questionnaire (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.