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Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Family-centered occupational therapy
regular occupational therapy
intervention done outside our hospital
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Family-centered, Autism spectrum disorder, Occupational therapy, Participation, Play

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Treatment group

Control group 1

Control group 2

Arm Description

Patients who receive 'family-centered occupational therapy' in our hospital

Patients who receive regular occupational therapy in our hospital

Patients who don't receive intervention in our hospital

Outcomes

Primary Outcome Measures

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").
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)
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)

Secondary Outcome Measures

Parenting Stress Index Short Form (PSI/SF)
Family Outcomes Survey (FOS)
Family Empowerment Scale (FES)
Home Observation for Measurement of the Environment (HOME)

Full Information

First Posted
May 22, 2016
Last Updated
December 26, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02795611
Brief Title
Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD
Official Title
Effectiveness of Family Centered Occupational Therapy on Play Skills and Participation of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Family-centered, Autism spectrum disorder, Occupational therapy, Participation, Play

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients who receive 'family-centered occupational therapy' in our hospital
Arm Title
Control group 1
Arm Type
Active Comparator
Arm Description
Patients who receive regular occupational therapy in our hospital
Arm Title
Control group 2
Arm Type
Other
Arm Description
Patients who don't receive intervention in our hospital
Intervention Type
Behavioral
Intervention Name(s)
Family-centered occupational therapy
Intervention Description
Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.
Intervention Type
Behavioral
Intervention Name(s)
regular occupational therapy
Intervention Description
regular occupational therapy
Intervention Type
Other
Intervention Name(s)
intervention done outside our hospital
Intervention Description
intervention done outside our hospital
Primary Outcome Measure Information:
Title
Goal Attainment Scale (GAS)
Description
GAS is a measure we used to assessed change between three time points ("Change from Baseline and at 3 months and at 6 months").
Time Frame
pre-test before intervention and post-test after 3 months and 6 months of intervention
Title
Revised Knox Preschool Play Scale (RKPPS)
Description
RKPPS is a measure we used to assessed change between two time points ("Change from Baseline and at 6 months)
Time Frame
pre-test before intervention and post-test after 6 months of intervention
Title
Vineland Adaptive Behavior Scale-Chinese version (VABS-C)
Description
VABS-C is a measure we used to assessed change between two time points ("Change from Baseline and at 6 months)
Time Frame
pre-test before intervention and post-test after 6 months of intervention
Secondary Outcome Measure Information:
Title
Parenting Stress Index Short Form (PSI/SF)
Time Frame
pre-test and post-test after 6 month
Title
Family Outcomes Survey (FOS)
Time Frame
pre-test and post-test after 6 month
Title
Family Empowerment Scale (FES)
Time Frame
pre-test and post-test after 6 month
Title
Home Observation for Measurement of the Environment (HOME)
Time Frame
pre-test and post-test after 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Hui Tseng, PhD
Organizational Affiliation
National Taiwan University School of Occupational Therapy
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD

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