- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795611
Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD
Effectiveness of Family Centered Occupational Therapy on Play Skills and Participation of Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhongzheng
-
Taipei, Zhongzheng, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment group
Patients who receive 'family-centered occupational therapy' in our hospital
|
Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.
|
|
ACTIVE_COMPARATOR: Control group 1
Patients who receive regular occupational therapy in our hospital
|
regular occupational therapy
|
|
OTHER: Control group 2
Patients who don't receive intervention in our hospital
|
intervention done outside our hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scale (GAS)
Time Frame: pre-test before intervention and post-test after 3 months and 6 months of intervention
|
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
|
|
Revised Knox Preschool Play Scale (RKPPS)
Time Frame: pre-test before intervention and post-test after 6 months of intervention
|
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
|
|
Vineland Adaptive Behavior Scale-Chinese version (VABS-C)
Time Frame: pre-test before intervention and post-test after 6 months of intervention
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parenting Stress Index Short Form (PSI/SF)
Time Frame: pre-test and post-test after 6 month
|
pre-test and post-test after 6 month
|
|
Family Outcomes Survey (FOS)
Time Frame: pre-test and post-test after 6 month
|
pre-test and post-test after 6 month
|
|
Family Empowerment Scale (FES)
Time Frame: pre-test and post-test after 6 month
|
pre-test and post-test after 6 month
|
|
Home Observation for Measurement of the Environment (HOME)
Time Frame: pre-test and post-test after 6 month
|
pre-test and post-test after 6 month
|
Collaborators and Investigators
Investigators
- Study Director: Mei-Hui Tseng, PhD, National Taiwan University School of Occupational Therapy
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201509008RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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