Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Taipei Medical University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- change from baseline functional performance (scores) at 6 weeks
Study Overview
Brief Summary
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;
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Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
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Assess the family strain by work shop for parents of children with developmental delays.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Months to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 M/O to 36 M/O children with developmental delays, under regular rehabilitation programs
Exclusion Criteria
- •less than 18 M/O and older than 36 M/O failed to obtain written informed consent
Arms & Interventions
study group
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
Intervention: family work shop (Other)
control group
children with developmental delays, under regular rehabilitation programs, not participate the family work shop
Outcomes
Primary Outcomes
change from baseline functional performance (scores) at 6 weeks
Time Frame: baseline and up to 6 weeks
Pediatric Outcome Data Collection Instrument
Secondary Outcomes
- change from baseline family strain (scores) at 6 weeks(baseline and up to 6 weeks)
- change from baseline health-related quality of life (scores) at 6 weeks(baseline and up to 6 weeks)
- change from baseline caregiver health-related quality of life (scores) at 6 weeks(baseline and up to 6 weeks)
- change from baseline family impact(baseline and up to 6 weeks)
Investigators
Ru-Lan Hsieh
Professor
Taipei Medical University