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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02115334
Enrollment
60
Registered
2014-04-16
Start date
2011-05-31
Completion date
2014-07-31
Last updated
2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Delay

Keywords

Developmental delay, Early Intervention, Home programs, Preschool activities

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.

Interventions

BEHAVIORALprofessional 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).

BEHAVIORALparents executing the PHPA

PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.

BEHAVIORALhealth education

health education of the children with DD.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 monthsbaseline, 8 weeks, 3 months, 6 monthsThe clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026