Autism Clinical Trial
— SCIT-AOfficial title:
Social Cognition and Interaction Training for Autism (SCIT-A)
Verified date | April 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 69 Years |
Eligibility |
Inclusion Criteria: 1. Between the ages of 13-69. 2. Symptoms of a neurodevelopmental disorder. 3. English as primary language and ability to speak in fluent, full length sentences: Treatment will be conducted in a group setting in English. Exclusion Criteria: 1. Inability to speak English fluently. |
Country | Name | City | State |
---|---|---|---|
United States | Carolina Institute for Developmental Disabilities | Carrboro | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Carolina Institute for Developmental Disabilities, North Carolina Translational and Clinical Sciences Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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. |
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