Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay

Not Applicable

Completed

• Conditions: Developmental Delay

• Registration Number: NCT02115334
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.

Detailed Description

A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention.

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-06
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 0 to 6-years-old children
• clinical diagnosis of DD and other related disorders

Exclusion Criteria

• unstable physiological conditions
• progression or regression symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months	baseline, 8 weeks, 3 months, 6 months	The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).

Secondary Outcome Measures

Name	Time	Method
change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months	baseline, 8 weeks, 3 months, 6 months	Measurement of CCDI.
change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months	baseline, 8 weeks, 3 months, 6 months	Measurement of APCP.
change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months	baseline, 8 weeks, 3 months, 6 months	Measurement of TAPQOL.
change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months	baseline, 8 weeks, 3 months, 6 months	Measurement of PSI.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan