Development DelayNCT03209453
Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial
A study testing family work shop in people with Development Delay, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Development Delay
- What is being tested?
- family work shop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2017to Dec 2017
- 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 children with developmental delays, under regular rehabilitation programs
Who cannot join
- less than 18 M/O and older than 36 M/O failed to obtain written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial
To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays
Read the detailed description
- The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;
- Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
- Assess the family strain by work shop for parents of children with developmental delays.
- Conditions
- Development Delay
- Being tested
- family work shop
- Keywords
- family work shop
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family work shopOther
Children with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | children with developmental delays, under regular rehabilitation programs, participate the family work shop family work shop: 6 families in one course, 2 hours per session, one session per week, a total of 6 weeks Receives: Other: family work shop |
| control group | No intervention | children with developmental delays, under regular rehabilitation programs, not participate the family work shop |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline functional performance (scores) at 6 weeks
Pediatric Outcome Data Collection Instrument
Measured: baseline and up to 6 weeks
Secondary outcomes (4)
change from baseline health-related quality of life (scores) at 6 weeks
Child Health Questionnaire
Measured: baseline and up to 6 weeks
change from baseline caregiver health-related quality of life (scores) at 6 weeks
World Health Organization Quality of Life: brief form
Measured: baseline and up to 6 weeks
change from baseline family strain (scores) at 6 weeks
Caregiver strain index
Measured: baseline and up to 6 weeks
change from baseline family impact
Pediatric Quality of Life Inventory: Family impact module
Measured: baseline and up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209453
- Sponsor's protocol ID
- DOH-SKH-106
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03209453
- Acronym / sponsor ID
- DOH-SKH-106
- Conditions
- Development Delay
- Keywords
- family work shop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jul 2017 (actual)
- 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 therapeutic effects of short-term family-centered work shop for children with developmental delays
Detailed description
- The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;
- Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
- Assess the family strain by work shop for parents of children with developmental delays.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: family work shopchildren with developmental delays, under regular rehabilitation programs, participate the family work shop family work shop: 6 families in one course, 2 hours per session, one session per week, a total of 6 weeks |
| control group | No intervention | –children with developmental delays, under regular rehabilitation programs, not participate the 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 children with developmental delays, under regular rehabilitation programs
Key exclusion criteria (1 listed)
- less than 18 M/O and older than 36 M/O 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 shopChildren with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks. | Other | study group |
Primary outcome
change from baseline functional performance (scores) at 6 weeks
Time frame: baseline and up to 6 weeks
Pediatric Outcome Data Collection Instrument
4 secondary outcomes
change from baseline health-related quality of life (scores) at 6 weeks
Time frame: baseline and up to 6 weeks
change from baseline caregiver health-related quality of life (scores) at 6 weeks
Time frame: baseline and up to 6 weeks
change from baseline family strain (scores) at 6 weeks
Time frame: baseline and up to 6 weeks
change from baseline family impact
Time frame: baseline and up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: No
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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.
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 Development Delay, 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 6 Jul 2017. 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?
Contact Ru-Lan Hsieh (228332211, 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 from baseline functional performance (scores) at 6 weeks (time frame: baseline and up to 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 6 Jul 2017.