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

Not Applicable

• Conditions: Development Delay
• Interventions: Other: family work shop

• Registration Number: NCT03209453
• Lead Sponsor: Taipei Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Last Update Submitted: 2017-07-04
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	family work shop	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

Primary Outcome Measures

Name	Time	Method
change from baseline functional performance (scores) at 6 weeks	baseline and up to 6 weeks	Pediatric Outcome Data Collection Instrument

Secondary Outcome Measures

Name	Time	Method
change from baseline family strain (scores) at 6 weeks	baseline and up to 6 weeks	Caregiver strain index
change from baseline health-related quality of life (scores) at 6 weeks	baseline and up to 6 weeks	Child Health Questionnaire
change from baseline caregiver health-related quality of life (scores) at 6 weeks	baseline and up to 6 weeks	World Health Organization Quality of Life: brief form
change from baseline family impact	baseline and up to 6 weeks	Pediatric Quality of Life Inventory: Family impact module

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan