NCT02795611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

May 22, 2016

Last Update Submit

December 26, 2017

Conditions

Autism Spectrum Disorder

Keywords

Family-centeredAutism spectrum disorderOccupational therapyParticipationPlay

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Parenting Stress Index Short Form (PSI/SF)

    pre-test and post-test after 6 month

  • Family Outcomes Survey (FOS)

    pre-test and post-test after 6 month

  • Family Empowerment Scale (FES)

    pre-test and post-test after 6 month

  • Home Observation for Measurement of the Environment (HOME)

    pre-test and post-test after 6 month

Study Arms (3)

Treatment group

EXPERIMENTAL

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

Behavioral: Family-centered occupational therapy

Control group 1

ACTIVE COMPARATOR

Patients who receive regular occupational therapy in our hospital

Behavioral: regular occupational therapy

Control group 2

OTHER

Patients who don't receive intervention in our hospital

Other: intervention done outside our hospital

Interventions

Family-centered occupational therapyBEHAVIORAL

Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.

Treatment group
regular occupational therapyBEHAVIORAL

regular occupational therapy

Control group 1
intervention done outside our hospitalOTHER

intervention done outside our hospital

Control group 2

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patient diagnosed with Autism spectrum disorder
  • age 2\~6 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng, 100, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mei-Hui Tseng, PhD

    National Taiwan University School of Occupational Therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2016

First Posted

June 10, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 28, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)