AutismSCIT-ANCT02382172
Social Cognition and Interaction Training for Autism
A study testing Social Cognition and Interaction Training for Autism (SCIT-A) and Treatment as Usual (TAU) in people with Autism and Social Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. Read more about this study
- Who is it for?
- Ages 10 to 69 years
- Conditions the study is for
- Autism, Social Behavior
- What is being tested?
- Social Cognition and Interaction Training for Autism (SCIT-A) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 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 10 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between the ages of 13-69.
- Symptoms of a neurodevelopmental disorder.
- English as primary language and ability to speak in fluent, full length sentences: Treatment will be conducted in a group setting in English.
Who cannot join
- 1. Inability to speak English fluently.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
About this study
Official title: Social Cognition and Interaction Training for Autism (SCIT-A)
Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. The therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.
Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions.
Procedures: Participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. The post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. The entire study duration is expected to be approximately 17 weeks. These outcome measures will measure the effectiveness of the treatment.
- Conditions
- Autism, Social Behavior
- Being tested
- Social Cognition and Interaction Training for Autism (SCIT-A), Treatment as Usual (TAU)
- Medical subject headings
- Autistic Disorder, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition and Interaction Training for Autism (SCIT-A)Behavioural
The group therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.
Participants in the treatment as usual (TAU) group will continue to receive other interventions (e.g., individual therapy, job skills coaching) during the Social Skills Clinic. No participants in either group will participate in other group-based interventions concurrently with their participation in this study.
| Study group | Role | What they receive |
|---|---|---|
| Social Cognition and Interaction Training for Autism (SCIT-A) | Experimental | The measures the investigators are giving assess participants' initial level of social deficits and the extent to which the therapy did or did not help their social skills. The research team will compare the level of difficulty that participants first reported with their subjective evaluation of their experience in the group sessions to determine whether the program is clinically useful for further development. The investigators will also have the participants complete eye tracking paradigms to assess possible changes in social functioning after completing the Social Cognition and Interaction Training for Autism (SCIT-A) program. Receives: Behavioral: Social Cognition and Interaction Training for Autism (SCIT-A) |
| Treatment As Usual (TAU) | Other | Continuation of services being given upon study entry. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm
Participants will complete an eyetracking task both before and after the Social Skills training clinic. The eyetracking task will be presented on a Tobii 1750 eyetracker integrated with a 17" display monitor (Tobii Technology, Stockholm, Sweden). The task will be an interactive visual exploration task that is a validated measure of social attention. It's a 15-minute eye tracking task, which is non-invasive and completely safe. During the task, participants will be asked to look at two children playing together. The Tobii eyetracker will record where the participants focus their gaze and for how long.
Measured: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Secondary outcomes (3)
Change in patient social skills as measured by the Social Responsiveness Scale (SRS)
Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.
Measured: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Change in patient social cognition as measured by the Hinting Task
This is a measure of Theory of Mind (ToM, i.e. ability to understand others' mental states). It consists of ten short vignettes involving social interactions between two characters, one of whom drops a hint at the end of the vignette about their desire or intention. The participant is asked to infer what the character means by their hint. This task will be completed at all testing visits. All participant groups will be asked to complete the Hinting task.
Measured: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Change in patient social cognition as measured by the Penn Emotion Recognition Task-40 (ER40)
This task measures face processing and emotion perception. The ER40 is a standardized test of facial emotion recognition ability consisting of color photographs of evoked expressions from adult actors displaying four basic emotions (happy, sad, angry, and fearful) and neutral facial expressions. This task takes approximately 5 minutes to complete and will be administered at each testing visit. All participant groups will be asked to complete the ER40 task.
Measured: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute, Carolina Institute for Developmental Disabilities
- Responsible party
- Sponsor
- Investigators
- Gabriel Dichter, MA, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382172
- Sponsor's protocol ID
- 14-2804
- Acronym
- SCIT-A
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Interaction Training for Autism (SCIT-A)
- ClinicalTrials.gov ID
- NCT02382172
- Acronym / sponsor ID
- SCIT-A / 14-2804
- Conditions
- Autism, Social Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute, Carolina Institute for Developmental Disabilities
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Mar 2015 (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.
Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. The therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.
Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions.
Procedures: Participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. The post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. The entire study duration is expected to be approximately 17 weeks. These outcome measures will measure the effectiveness of the treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Cognition and Interaction Training for Autism (SCIT-A) | Experimental | Behavioral: Social Cognition and Interaction Training for Autism (SCIT-A)The measures the investigators are giving assess participants' initial level of social deficits and the extent to which the therapy did or did not help their social skills. The research team will compare the level of difficulty that participants first reported with their subjective evaluation of their experience in the group sessions to determine whether the program is clinically useful for further development. The investigators will also have the participants complete eye tracking paradigms to assess possible changes in social functioning after completing the Social Cognition and Interaction Training for Autism (SCIT-A) program. |
| Treatment As Usual (TAU) | Other | Other: Treatment as Usual (TAU)Continuation of services being given upon study entry. |
Who may qualify
- Ages
- 10 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 13-69.
- Symptoms of a neurodevelopmental disorder.
- English as primary language and ability to speak in fluent, full length sentences: Treatment will be conducted in a group setting in English.
Key exclusion criteria (1 listed)
- 1. Inability to speak English fluently.
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 Cognition and Interaction Training for Autism (SCIT-A)The group therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions. | Behavioural | Social Cognition and Interaction Training for Autism (SCIT-A) |
| Treatment as Usual (TAU)Participants in the treatment as usual (TAU) group will continue to receive other interventions (e.g., individual therapy, job skills coaching) during the Social Skills Clinic. No participants in either group will participate in other group-based interventions concurrently with their participation in this study. | Other | Treatment As Usual (TAU) |
Primary outcome
Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm
Time frame: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Participants will complete an eyetracking task both before and after the Social Skills training clinic. The eyetracking task will be presented on a Tobii 1750 eyetracker integrated with a 17" display monitor (Tobii Technology, Stockholm, Sweden). The task will be an interactive visual exploration task that is a validated measure of social attention. It's a 15-minute eye tracking task, which is non-invasive and completely safe. During the task, participants will be asked to look at two children playing together. The Tobii eyetracker will record where the participants focus their gaze and for how long.
3 secondary outcomes
Change in patient social skills as measured by the Social Responsiveness Scale (SRS)
Time frame: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Change in patient social cognition as measured by the Hinting Task
Time frame: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
Change in patient social cognition as measured by the Penn Emotion Recognition Task-40 (ER40)
Time frame: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.
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 25 Apr 2017.
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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.
Gabriel Dichter, MA, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition and Interaction Training for Autism (SCIT-A) and Treatment as Usual (TAU) in people with Autism and Social Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 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 25 Apr 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 United States. 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?
Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm (time frame: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.). 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 25 Apr 2017.