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

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ClinicalTrials.gov Identifier: NCT02795611
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Family-centered occupational therapy Behavioral: regular occupational therapy Other: intervention done outside our hospital Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Family Centered Occupational Therapy on Play Skills and Participation of Children With Autism Spectrum Disorder
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Patients who receive 'family-centered occupational therapy' in our hospital
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.

Active Comparator: Control group 1
Patients who receive regular occupational therapy in our hospital
Behavioral: regular occupational therapy
regular occupational therapy

Control group 2
Patients who don't receive intervention in our hospital
Other: intervention done outside our hospital
intervention done outside our hospital




Primary Outcome Measures :
  1. 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").

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. Parenting Stress Index Short Form (PSI/SF) [ Time Frame: pre-test and post-test after 6 month ]
  2. Family Outcomes Survey (FOS) [ Time Frame: pre-test and post-test after 6 month ]
  3. Family Empowerment Scale (FES) [ Time Frame: pre-test and post-test after 6 month ]
  4. Home Observation for Measurement of the Environment (HOME) [ Time Frame: pre-test and post-test after 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02795611


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Mei-Hui Tseng, PhD National Taiwan University School of Occupational Therapy
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02795611    
Other Study ID Numbers: 201509008RINC
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
Family-centered
Autism spectrum disorder
Occupational therapy
Participation
Play
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders