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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209453
Recruitment Status : Unknown
Verified July 2017 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

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

Condition or disease Intervention/treatment Phase
Development Delay Other: family work shop Not Applicable

Detailed Description:

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;

  1. Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
  2. Assess the family strain by work shop for parents of children with developmental delays.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 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
Other: family work shop
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.

No Intervention: control group
children with developmental delays, under regular rehabilitation programs, not participate the family work shop



Primary Outcome Measures :
  1. change from baseline functional performance (scores) at 6 weeks [ Time Frame: baseline and up to 6 weeks ]
    Pediatric Outcome Data Collection Instrument


Secondary Outcome Measures :
  1. change from baseline health-related quality of life (scores) at 6 weeks [ Time Frame: baseline and up to 6 weeks ]
    Child Health Questionnaire

  2. change from baseline caregiver health-related quality of life (scores) at 6 weeks [ Time Frame: baseline and up to 6 weeks ]
    World Health Organization Quality of Life: brief form

  3. change from baseline family strain (scores) at 6 weeks [ Time Frame: baseline and up to 6 weeks ]
    Caregiver strain index

  4. change from baseline family impact [ Time Frame: baseline and up to 6 weeks ]
    Pediatric Quality of Life Inventory: Family impact module



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209453


Contacts
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Contact: Ru-Lan Hsieh 228332211 M001052@ms.skh.org.tw

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
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Responsible Party: Ru-Lan Hsieh, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03209453    
Other Study ID Numbers: DOH-SKH-106
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
family work shop