Clinical trial NCT02382172: Social Cognition and Interaction Training for Autism
Official title: Social Cognition and Interaction Training for Autism (SCIT-A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Social Behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
name: Carolina Institute for Developmental Disabilities
First posted: 2015-03-06
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm
timeFrame: 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:
measure: Change in patient social skills as measured by the Social Responsiveness Scale (SRS)
timeFrame: 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.
measure: Change in patient social cognition as measured by the Hinting Task
timeFrame: 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.
measure: Change in patient social cognition as measured by the Penn Emotion Recognition Task-40 (ER40)
timeFrame: 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.
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: Carolina Institute for Developmental Disabilities
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gabriel Dichter, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References: