Autism Spectrum DisorderNCT02795611
Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD
A study testing Family-centered occupational therapy, regular occupational therapy and intervention done outside our hospital in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Family-centered occupational therapy, regular occupational therapy and intervention done outside our hospital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patient diagnosed with Autism spectrum disorder
- age 2~6 years old
Who cannot join
- patient with other disease, like seizure or other systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Family Centered Occupational Therapy on Play Skills and Participation of Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Family-centered occupational therapy, regular occupational therapy, intervention done outside our hospital
- Keywords
- Family-centered, Autism spectrum disorder, Occupational therapy, Participation, Play
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered occupational therapyBehavioural
Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.
regular occupational therapyBehavioural
regular occupational therapy
intervention done outside our hospitalOther
intervention done outside our hospital
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients who receive 'family-centered occupational therapy' in our hospital Receives: Behavioral: Family-centered occupational therapy |
| Control group 1 | Active comparator | Patients who receive regular occupational therapy in our hospital Receives: Behavioral: regular occupational therapy |
| Control group 2 | Other | Patients who don't receive intervention in our hospital Receives: Other: intervention done outside our hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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)
Measured: 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)
Measured: pre-test before intervention and post-test after 6 months of intervention
Secondary outcomes (4)
Parenting Stress Index Short Form (PSI/SF)
Measured: pre-test and post-test after 6 month
Family Outcomes Survey (FOS)
Measured: pre-test and post-test after 6 month
Family Empowerment Scale (FES)
Measured: pre-test and post-test after 6 month
Home Observation for Measurement of the Environment (HOME)
Measured: pre-test and post-test after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Hui Tseng, PhD, Study director, National Taiwan University School of Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795611
- Sponsor's protocol ID
- 201509008RINC
- Status last verified
- Dec 2017
- First submitted
- 22 May 2016
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Family Centered Occupational Therapy on Play Skills and Participation of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02795611
- Acronym / sponsor ID
- 201509008RINC
- Conditions
- Autism Spectrum Disorder
- Keywords
- Family-centered, Autism spectrum disorder, Occupational therapy, Participation, Play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Family-centered occupational therapyPatients who receive 'family-centered occupational therapy' in our hospital |
| Control group 1 | Active comparator | Behavioral: regular occupational therapyPatients who receive regular occupational therapy in our hospital |
| Control group 2 | Other | Other: intervention done outside our hospitalPatients who don't receive intervention in our hospital |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patient diagnosed with Autism spectrum disorder
- age 2~6 years old
Key exclusion criteria (1 listed)
- patient with other disease, like seizure or other systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-centered occupational therapyCaregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life. | Behavioural | Treatment group |
| regular occupational therapyregular occupational therapy | Behavioural | Control group 1 |
| intervention done outside our hospitalintervention done outside our hospital | Other | Control group 2 |
Primary outcome
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").
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)
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)
4 secondary outcomes
Parenting Stress Index Short Form (PSI/SF)
Time frame: pre-test and post-test after 6 month
Family Outcomes Survey (FOS)
Time frame: pre-test and post-test after 6 month
Family Empowerment Scale (FES)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Hui Tseng, PhD study director
National Taiwan University School of Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered occupational therapy, regular occupational therapy and intervention done outside our hospital in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale (GAS) (time frame: pre-test before intervention and post-test after 3 months and 6 months of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.