Developmental DelaysNCT02181036
Effects of Work Shop for Children With Developmental Delays
A study testing family work shop in people with Developmental Delays, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
To identify the effects of family work shop for children with speech developmental delays. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- 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
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Jan 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- 18 M/O to 36 M/O of children with speech development delay
Who cannot join
- less than 18 M/O older than 36 M/O
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Family Work Shop for Children With Speech Developmental Delays
To identify the effects of family work shop for children with speech developmental delays.
Read the detailed description
To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop
- Conditions
- Developmental Delays
- Being tested
- family work shop
- Keywords
- Family work shop, speech developmental delays, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family work shopOther
2-3 hours per session, one session per week, a total of 6 weeks of family work shop
| Study group | Role | What they receive |
|---|---|---|
| family work shop | Experimental | 2 to 3 hours per session, one session per week, for a total of 6 weeks of family work shop Receives: Other: family work shop |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of pediatric health related quality of life (Pediatric Quality of Life Inventory)
participants receive one 2-hour session of work shop per week for a 6-week duration
Measured: participants will be evaluated at before and after 6 weeks of work shop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ru-Lan Hsieh, MD, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181036
- Sponsor's protocol ID
- DOH-SKH-103-07
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family Work Shop for Children With Speech Developmental Delays
- ClinicalTrials.gov ID
- NCT02181036
- Acronym / sponsor ID
- DOH-SKH-103-07
- Conditions
- Developmental Delays
- Keywords
- Family work shop, speech developmental delays, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 3 Jul 2014 (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.
To identify the effects of family work shop for children with speech developmental delays.
Detailed description
To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| family work shop | Experimental | Other: family work shop2 to 3 hours per session, one session per week, for a total of 6 weeks of family work shop |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 18 M/O to 36 M/O of children with speech development delay
Key exclusion criteria (1 listed)
- less than 18 M/O older than 36 M/O
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 shop2-3 hours per session, one session per week, a total of 6 weeks of family work shop | Other | family work shop |
Primary outcome
changes of pediatric health related quality of life (Pediatric Quality of Life Inventory)
Time frame: participants will be evaluated at before and after 6 weeks of work shop
participants receive one 2-hour session of work shop per week for a 6-week duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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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 study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 3 Jul 2014. 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?
Results are not available in the source record.
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?
changes of pediatric health related quality of life (Pediatric Quality of Life Inventory) (time frame: participants will be evaluated at before and after 6 weeks of work shop). 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 3 Jul 2014.