Clinical trial NCT02795611: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Family-centered
Autism spectrum disorder
Occupational therapy
Participation
Play
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: pre-test before intervention and post-test after 3 months and 6 months of intervention
measure: Revised Knox Preschool Play Scale (RKPPS)
timeFrame: pre-test before intervention and post-test after 6 months of intervention
measure: Vineland Adaptive Behavior Scale-Chinese version (VABS-C)
timeFrame: pre-test before intervention and post-test after 6 months of intervention
Secondary outcomes:
measure: Parenting Stress Index Short Form (PSI/SF)
timeFrame: pre-test and post-test after 6 month
measure: Family Outcomes Survey (FOS)
timeFrame: pre-test and post-test after 6 month
measure: Family Empowerment Scale (FES)
timeFrame: pre-test and post-test after 6 month
measure: Home Observation for Measurement of the Environment (HOME)
timeFrame: pre-test and post-test after 6 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
Study officials:
affiliation: National Taiwan University School of Occupational Therapy
name: Mei-Hui Tseng, PhD
role: STUDY_DIRECTOR
References: