Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial

Study Overview
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Brief Summary
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To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

Detailed Description
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1. 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.

Official Title
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Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial

Conditions
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Development Delay

Intervention / Treatment
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* Other: family work shop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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 | Other: family work shop<br>* 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.<br>|
| No Intervention: control group<br>children with developmental delays, under regular rehabilitation programs, not participate the family work shop | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline functional performance (scores) at 6 weeks | Pediatric Outcome Data Collection Instrument | baseline and up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline health-related quality of life (scores) at 6 weeks | Child Health Questionnaire | 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 | baseline and up to 6 weeks | 
| change from baseline family strain (scores) at 6 weeks | Caregiver strain index | baseline and up to 6 weeks | 
| change from baseline family impact | Pediatric Quality of Life Inventory: Family impact module | baseline and up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family work shop