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Social Cognition and Interaction Training for Autism (SCIT-A)

Primary Purpose

Autism, Social Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Cognition and Interaction Training for Autism (SCIT-A)
Treatment as Usual (TAU)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism

Eligibility Criteria

10 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carolina Institute for Developmental Disabilities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Social Cognition and Interaction Training for Autism (SCIT-A)

Treatment As Usual (TAU)

Arm Description

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.

Continuation of services being given upon study entry.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 23, 2015
Last Updated
April 21, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute, Carolina Institute for Developmental Disabilities
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1. Study Identification

Unique Protocol Identification Number
NCT02382172
Brief Title
Social Cognition and Interaction Training for Autism
Acronym
SCIT-A
Official Title
Social Cognition and Interaction Training for Autism (SCIT-A)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute, Carolina Institute for Developmental Disabilities

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Social Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Cognition and Interaction Training for Autism (SCIT-A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
Other
Arm Description
Continuation of services being given upon study entry.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition and Interaction Training for Autism (SCIT-A)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in patient social skills as measured by the Social Responsiveness Scale (SRS)
Description
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.
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.
Title
Change in patient social cognition as measured by the Hinting Task
Description
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.
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.
Title
Change in patient social cognition as measured by the Penn Emotion Recognition Task-40 (ER40)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Inability to speak English fluently.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Dichter, MA, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Institute for Developmental Disabilities
City
Carrboro
State/Province
North Carolina
ZIP/Postal Code
27510
Country
United States

12. IPD Sharing Statement

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Social Cognition and Interaction Training for Autism

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