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

NCT ID: NCT02115334

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

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.

Conditions

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Developmental Delay

Keywords

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Developmental delay Early Intervention Home programs Preschool activities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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professional-based group

professional therapists delivering the PHPA

Group Type EXPERIMENTAL

professional therapists delivering the PHPA

Intervention Type BEHAVIORAL

PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).

parents-based group

parents executing the PHPA

Group Type EXPERIMENTAL

parents executing the PHPA

Intervention Type BEHAVIORAL

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

control group

health education only

Group Type ACTIVE_COMPARATOR

health education

Intervention Type BEHAVIORAL

health education of the children with DD.

Interventions

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professional 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).

Intervention Type BEHAVIORAL

parents executing the PHPA

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

Intervention Type BEHAVIORAL

health education

health education of the children with DD.

Intervention Type BEHAVIORAL

Other Intervention Names

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PHPA(delivered by professional therapists) PHPA (executed by parents)

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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling Chen, MD,PhD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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100-0996A3

Identifier Type: -

Identifier Source: org_study_id