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

Developmental Delay Clinical Trial

Official title:

Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115334
• Other study ID #: 100-0996A3
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: February 25, 2015
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Behavioral:
• professional therapists delivering the PHPA
PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).
• parents executing the PHPA
PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.
• health education
health education of the children with DD.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months	The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).	baseline, 8 weeks, 3 months, 6 months	No
Secondary	change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months	Measurement of CCDI.	baseline, 8 weeks, 3 months, 6 months	No
Secondary	change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months	Measurement of APCP.	baseline, 8 weeks, 3 months, 6 months	No
Secondary	change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months	Measurement of TAPQOL.	baseline, 8 weeks, 3 months, 6 months	No
Secondary	change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months	Measurement of PSI.	baseline, 8 weeks, 3 months, 6 months	No