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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02795611
Other study ID # 201509008RINC
Secondary ID
Status Completed
Phase N/A
First received May 22, 2016
Last updated December 26, 2017
Start date May 2016
Est. completion date December 2017

Study information

Verified date December 2017
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Play skills and participation of children with Autism Spectrum Disorder (ASD) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. This research aims to improve play skills and participation of children with ASD through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family.


Description:

Play skills and participation of children with Autism Spectrum Disorder (ASD) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. This research aims to improve play skills and participation of children with ASD through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family.

60 children age 2~6 with ASD will be recruited in our research, and divided into either experimental or control groups according to primary caregivers' (will be referred to as caregivers thereafter) decision whether to receive treatment in our hospital (NTUH) or not. Caregivers' decision is based on the convenience of transportation to NTUH. The children with ASD in the experimental group will receive family-centered occupational therapy three times a week for 6 months. The intervention goals, determined by discussing with caregivers, will often be the most important aspect of play skill and participation of children with ASD, which concern caregivers most. Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life. The outcome assessments will include : (1) The child's developmental skills and the severity of ASD as measured with Psychoeducational Profile, third edition (PEP-3) and Childhood Autism Rating Scale (CARS) respectively, (2) the child's play skill and participation as measured with Goal Attainment Scale (GAS), Vineland Adaptive Behavior Scale-Chinese version (VABS-C) and Revised Knox Preschool Play Scale (RKPPS) respectively, (3) Family related factors as measured with Parenting Stress Index Short Form (PSI/SF), Family Outcomes Survey (FOS), Family Empowerment Scale (FES) and Home Observation for Measurement of the Environment (HOME).

Pre- and post-intervention comparison on the outcome measures within the experimental group, and group comparison on the outcome measures will be conducted to examine the effectiveness of family-centered occupational therapy. Results of the study will provide empirical evidence for evidence-based occupational therapy practice in the field of play skills and participation of children with ASD.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 6 Years
Eligibility Inclusion Criteria:

- patient diagnosed with Autism spectrum disorder

- age 2~6 years old

Exclusion Criteria:

- patient with other disease, like seizure or other systemic disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family-centered occupational therapy
Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.
regular occupational therapy
regular occupational therapy
Other:
intervention done outside our hospital
intervention done outside our hospital

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei Zhongzheng

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Goal Attainment Scale (GAS) GAS is a measure we used to assessed change between three time points ("Change from Baseline and at 3 months and at 6 months"). pre-test before intervention and post-test after 3 months and 6 months of intervention
Primary Revised Knox Preschool Play Scale (RKPPS) RKPPS is a measure we used to assessed change between two time points ("Change from Baseline and at 6 months) pre-test before intervention and post-test after 6 months of intervention
Primary Vineland Adaptive Behavior Scale-Chinese version (VABS-C) VABS-C is a measure we used to assessed change between two time points ("Change from Baseline and at 6 months) pre-test before intervention and post-test after 6 months of intervention
Secondary Parenting Stress Index Short Form (PSI/SF) pre-test and post-test after 6 month
Secondary Family Outcomes Survey (FOS) pre-test and post-test after 6 month
Secondary Family Empowerment Scale (FES) pre-test and post-test after 6 month
Secondary Home Observation for Measurement of the Environment (HOME) pre-test and post-test after 6 month
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