Using Serious Games to Improve Social Skills in Autism

NCT03690661 | Completed DMC

• 1 other identifier: R33MH110624
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.

Conditions

Autism Spectrum Disorder; Autism

Keywords

adolescent; face; social skills; video game

Outcome Measures

Primary Outcomes (4)

• Primary Target Eye Gaze Mechanisms - Performance Accuracy

  Performance accuracy will be acquired from both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).

  6 months

• Primary Target Eye Gaze Mechanisms - Visual Fixation

  Eye tracking measures of visual fixation will be acquired in both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).

  6 months

• Social Symptoms - Social Skills Inventory System (SSIS)

  Social skills and problematic behaviors will be assessed via parent- and self-reported responses on the SSIS. These measures will be administered at multiple time points including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).

  6 months

• Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)

  To assess potential changes in autism-like behaviors and symptoms, parents will complete the SRS-2 at each of 3 time points (pre-intervention, post-intervention, 3-month follow-up after intervention completion).

  6 months

Secondary Outcomes (5)

• Intermediate Face Processing Mechanisms - Face Identity (CFMT)

  6 months

• Intermediate Face Processing Mechanisms - Object Identity (CBMT)

  6 months

• Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)

  6 months

• Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)

  6 months

• Face-to-Face Social Interactions - Visual Fixations

  6 months

Study Arms (2)

Intervention Video Game

EXPERIMENTAL

Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session

Behavioral: Intervention Video Game

Control Video Game

PLACEBO COMPARATOR

Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session

Behavioral: Placebo Control Game

Interventions

Intervention Video Game BEHAVIORAL

The intervention game employs evidence-based "serious game" mechanics (e.g., storylines, long-term goals, scaling difficulty) to design a learning environment that maximizes opportunities for adolescents with ASD to discover the functional utility of eye gaze cues.

Intervention Video Game

Placebo Control Game BEHAVIORAL

The placebo game will have all the elements of the serious game mechanics of the intervention game (narrative storylines, long-term goals, scaling difficulty), but will not provide the learning opportunities regarding eye gaze cues.

Control Video Game

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD),
• parent/caregiver and adolescent with ASD both native English speakers,
• adolescent with ASD aged between 10-18 years at pre-test,
• adolescent has normal vision and hearing with correction as reported by caregiver,
• adolescent is able to use a computer for the purposes of game play,
• adolescent scores \< 80% correct (i.e., 0.5 SD less than Mean of typically developing adolescents) on online eye gaze screening task,
• ASD diagnosis of adolescent confirmed via Parent-report SCQ and clinical interview with adolescent to assess DSM-V criteria (borderline cases also undergo ADI interview);
• Full Scale IQ of adolescent determined to be between 70-130;
• reading ability of adolescent determined to be at least a 2nd grade level;
• adolescent is capable of cooperating with testing;
• parent/caregiver and adolescent both consent/assent to participate in the research.

You may not qualify if:

• having seizures within the previous two years
• no stable internet connection in the home
• refusing to consent/assent to take part in the research
• and have a legal guardian, which prohibits them from legally consenting for themselves
• and cannot understand the consent as indicated by failing a quiz prior to signing the consent.

Sponsors & Collaborators

• Penn State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Facies; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Suzy Scherf

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: December 1, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)