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Completed

NCT Number: NCT02382172

Social Cognition and Interaction Training for Autism

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Social Behavior

Age range

10 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Inability to speak English fluently.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Carolina Institute for Developmental Disabilities
  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

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

Acronym: SCIT-A

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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