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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Developmental Delay

Intervention / Treatment
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* Behavioral: professional therapists delivering the PHPA
* Behavioral: parents executing the PHPA
* Behavioral: health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Developmental delay, Early Intervention, Home programs, Preschool activities