Clinical trial NCT02115334: Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay
Official title: Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Keywords: Developmental delay
Early Intervention
Home programs
Preschool activities
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months
timeFrame: baseline, 8 weeks, 3 months, 6 months
Secondary outcomes:
measure: change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months
timeFrame: baseline, 8 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD,PhD
role: STUDY_DIRECTOR
References: