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

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

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.

Study Overview

• Status: Completed
• Conditions: Developmental Delay
• Intervention / Treatment: Behavioral: professional therapists delivering the PHPA; Behavioral: parents executing the PHPA; Behavioral: health education

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: professional-based group; professional therapists delivering the PHPA	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).; Other Names: PHPA(delivered by professional therapists)
Experimental: parents-based group; parents executing the PHPA	Behavioral: parents executing the PHPA; PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.; Other Names: PHPA (executed by parents)
Active Comparator: control group; health education only	Behavioral: health education; health education of the children with DD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Chia-Ling Chen, MD,PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Estimate): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Early Intervention; Developmental delay; Home programs; Preschool activities
• Other Study ID Numbers: 100-0996A3