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

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ClinicalTrials.gov Identifier: NCT02115334
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Developmental Delay Behavioral: professional therapists delivering the PHPA Behavioral: parents executing the PHPA Behavioral: health education Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: professional-based group
professional therapists delivering the PHPA
Behavioral: 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).
Other Name: PHPA(delivered by professional therapists)

Experimental: parents-based group
parents executing the PHPA
Behavioral: parents executing the PHPA
PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.
Other Name: PHPA (executed by parents)

Active Comparator: control group
health education only
Behavioral: health education
health education of the children with DD.




Primary Outcome Measures :
  1. Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months [ Time Frame: baseline, 8 weeks, 3 months, 6 months ]
    The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).


Secondary Outcome Measures :
  1. change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months [ Time Frame: baseline, 8 weeks, 3 months, 6 months ]
    Measurement of CCDI.

  2. change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months [ Time Frame: baseline, 8 weeks, 3 months, 6 months ]
    Measurement of APCP.

  3. change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months [ Time Frame: baseline, 8 weeks, 3 months, 6 months ]
    Measurement of TAPQOL.

  4. change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months [ Time Frame: baseline, 8 weeks, 3 months, 6 months ]
    Measurement of PSI.



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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115334


Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Chia-Ling Chen, MD,PhD Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02115334     History of Changes
Other Study ID Numbers: 100-0996A3
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: June 2011

Keywords provided by Chang Gung Memorial Hospital:
Developmental delay
Early Intervention
Home programs
Preschool activities