Autism Spectrum DisorderNCT04551313
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
A study testing social skill group in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- social skill group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Oct 2020to 27 Jul 2022
- 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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Autism spectrum disorder
- Must be able to understand 3-steps verbal commands
Who cannot join
- Mental retardation
- Seizure
Trial locations and contacts
2 sites in 1 country.
About this study
Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. They can't interpret the thoughts and feelings of others, or predict social events, and the impaired social skills may lead to rejection of peers and poor participation in school.
Social skills training targets the core symptoms of ASD. Empirical support is building for cognitive-behavioral intervention approach, social skills training group for verbally fluent, school-aged children with ASD. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
Read the detailed description
Many different intervention program have been used throughout the world. One alternative method used to teach children is the social stories method, which was created by Gray (1993) to address the social difficulties of children with ASD. The theoretical framework of the social stories is based on theory of mind (TOM) hypothesis. Difficulties associated with the impaired TOM was addressed by explaining the complex social concepts in simple words and often include the description of perspectives of others. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
In this study, we plan to randomly assign thirty-six 5-7-year-old children with ASD to one of two kinds of social skills groups: the social skills group or the play activities group (control condition). Group met for 16 weeks, one time per week, one hour each time. Participants were recruited between October 2020 and September 2023. Assessment were conducted at baseline and endpoint (16 weeks). To empower parents, we would also ask parents of participants to attend our treatment and lecture.
- Conditions
- Autism Spectrum Disorder
- Being tested
- social skill group
- Keywords
- Autism,autism spectrum disorder,social skill training
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social skill groupBehavioural
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
| Study group | Role | What they receive |
|---|---|---|
| social skill training group | Experimental | We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills. Receives: Behavioral: social skill group |
| control group | Active comparator | Regular therapy Receives: Behavioral: social skill group |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAS (Goal attainment scale)
interview caregivers about specific social interaction goals for the children and give rating 1-5 to calculate the extent to which a parent's goals are met.
Measured: the first week and the 15th week of the duration
Vineland Adaptive Behavior Scale
to assess the socialization skill of the children.
Measured: the first week and the 15th week of the duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Oct 2020
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Mei Chiang, MAMS, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551313
- Sponsor's protocol ID
- 202006158RINA
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2020
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04551313
- Acronym / sponsor ID
- 202006158RINA
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism,autism spectrum disorder,social skill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- 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.
Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. They can't interpret the thoughts and feelings of others, or predict social events, and the impaired social skills may lead to rejection of peers and poor participation in school.
Social skills training targets the core symptoms of ASD. Empirical support is building for cognitive-behavioral intervention approach, social skills training group for verbally fluent, school-aged children with ASD. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
Detailed description
Many different intervention program have been used throughout the world. One alternative method used to teach children is the social stories method, which was created by Gray (1993) to address the social difficulties of children with ASD. The theoretical framework of the social stories is based on theory of mind (TOM) hypothesis. Difficulties associated with the impaired TOM was addressed by explaining the complex social concepts in simple words and often include the description of perspectives of others. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
In this study, we plan to randomly assign thirty-six 5-7-year-old children with ASD to one of two kinds of social skills groups: the social skills group or the play activities group (control condition). Group met for 16 weeks, one time per week, one hour each time. Participants were recruited between October 2020 and September 2023. Assessment were conducted at baseline and endpoint (16 weeks). To empower parents, we would also ask parents of participants to attend our treatment and lecture.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| social skill training group | Experimental | Behavioral: social skill groupWe plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills. |
| control group | Active comparator | Behavioral: social skill groupRegular therapy |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of Autism spectrum disorder
- Must be able to understand 3-steps verbal commands
Key exclusion criteria (2 listed)
- Mental retardation
- Seizure
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 |
|---|---|---|
| social skill groupWe plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills. | Behavioural | control group, social skill training group |
Primary outcome
GAS (Goal attainment scale)
Time frame: the first week and the 15th week of the duration
interview caregivers about specific social interaction goals for the children and give rating 1-5 to calculate the extent to which a parent's goals are met.
Vineland Adaptive Behavior Scale
Time frame: the first week and the 15th week of the duration
to assess the socialization skill of the children.
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 18 Aug 2023.
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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.
Fu-Mei Chiang, MAMS principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social skill group in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 2 sites 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 2 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
GAS (Goal attainment scale) (time frame: the first week and the 15th week of the duration). The study lists 2 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 18 Aug 2023.