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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| professional-based group | Experimental | professional therapists delivering the PHPA |
|
| parents-based group | Experimental | parents executing the PHPA |
|
| control group | Active Comparator | health education only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| professional therapists delivering the PHPA | Behavioral | PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia-Ling Chen, MD,PhD | Chang Gung Memorial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| parents executing the PHPA | Behavioral | PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL. |
|
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| health education | Behavioral | health education of the children with DD. |
|
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |