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Clinical Trials/NCT03223688
NCT03223688
Completed
N/A

Effectiveness of Adjunctive Sensory Integration Therapy for Children With Developmental Delay in an Early Intervention Program

Chang Gung Memorial Hospital0 sites45 target enrollmentMay 12, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
Chang Gung Memorial Hospital
Enrollment
45
Primary Endpoint
Changes of children's development
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.

Detailed Description

This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.

Registry
clinicaltrials.gov
Start Date
May 12, 2014
End Date
May 11, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wang Liang-Jen

Associate Professor and Visiting Staff

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Children with Developmental Delay
  • The caregivers are able to participate in the treatment program

Exclusion Criteria

  • Cerebral palsy

Outcomes

Primary Outcomes

Changes of children's development

Time Frame: Assessment will be performed at baseline and 6-month after the baseline

Mullen Scales of Early Learning

Secondary Outcomes

  • Changes of caregivers' life quality(Assessment will be performed at baseline and 6-month after the baseline)
  • Changes of caregivers' parenting stress(Assessment will be performed at baseline and 6-month after the baseline)

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