Social Cognition and Interaction Training for Autism

NCT02382172 | Completed

• 1 other identifier: 14-2804
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Social Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in patient social skills as measured by the Social Responsiveness Scale (SRS)

  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

  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)

  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.

Study Arms (2)

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.

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

Treatment As Usual (TAU)

OTHER

Continuation of services being given upon study entry.

Other: Treatment as Usual (TAU)

Interventions

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

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.

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

Treatment as Usual (TAU) OTHER

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.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 10 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Inability to speak English fluently.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator
• Carolina Institute for Developmental Disabilities: collaborator

Study Sites (1)

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Social Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Gabriel Dichter, MA, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 6, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)