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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Developmental Delay

Treatments

Behavioral: parents executing the PHPA
Behavioral: professional therapists delivering the PHPA
Behavioral: health education

Study type

Interventional

Funder types

Other

Identifiers

NCT02115334
100-0996A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

Under 6 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

professional-based group
Experimental group
Description:
professional therapists delivering the PHPA
Treatment:
Behavioral: professional therapists delivering the PHPA
parents-based group
Experimental group
Description:
parents executing the PHPA
Treatment:
Behavioral: parents executing the PHPA
control group
Active Comparator group
Description:
health education only
Treatment:
Behavioral: health education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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