Developmental DelaysPhase 4NCT02523963
Effects of Family Work Shop for Children With Developmental Delays
A Phase 4 study testing family work shop in people with Developmental Delays, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify the effects of family work shop for children with developmental delays. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delays
- What is being tested?
- family work shop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Apr 2016
- Phase
- Phase 4
- 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 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop
Who cannot join
- Failed to obtain written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify the effects of family work shop for children with developmental delays.
Read the detailed description
Methods：
- 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.
- Conditions
- Developmental Delays
- Being tested
- family work shop
- Keywords
- family work shop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family work shopOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | children with developmental delays participated 6 sessions of family work shop
1. The family work shop has 5 courses, with 6 families in one course.
2. Intervention of one course: 2-3 hours per session, one time per week, for a total of 6 weeks. Receives: Other: family work shop |
| control | No intervention | children with normal development not participate the work shop followed up at before, and 6 weeks later |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in health related quality of life questionnaire
to identify the changes of health related quality of life of children after the workshop
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelaysStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, visiting staff of Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523963
- Sponsor's protocol ID
- H10427
- Status last verified
- Aug 2015
- First submitted
- 7 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family Work Shop for Children With Developmental Delays
- ClinicalTrials.gov ID
- NCT02523963
- Acronym / sponsor ID
- H10427
- Conditions
- Developmental Delays
- Keywords
- family work shop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 14 Aug 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.
The purpose of this study is to identify the effects of family work shop for children with developmental delays.
Detailed description
Methods：
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: family work shopchildren with developmental delays participated 6 sessions of family work shop 1. The family work shop has 5 courses, with 6 families in one course. 2. Intervention of one course: 2-3 hours per session, one time per week, for a total of 6 weeks. |
| control | No intervention | –children with normal development not participate the work shop followed up at before, and 6 weeks later |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop
Key exclusion criteria (1 listed)
- Failed to obtain written informed consent
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 |
|---|---|---|
| family work shop1. The family work shop has 5 courses, with 6 families in one course. 2. One course of intervention: 2-3 hours per session, one time per week, for a total of 6 sessions in 6 week periods | Other | study group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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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.
Ru-Lan Hsieh, MD principal investigator
visiting staff of Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing family work shop in people with Developmental Delays, run by Taipei Medical University 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: status not confirmed, as of the sponsor's last update on 14 Aug 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan h, MD (886-2-28332211 ext. 2538, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in health related quality of life questionnaire (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2015.