Using Serious Games to Improve Social Skills in Autism

Autism Spectrum Disorder Clinical Trial

— SAGA  

Official title:

Using Serious Games to Improve Social Skills in Autism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03690661
• Other study ID #: R33MH110624
• Secondary ID: R33MH110624
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators will conduct a small-scale randomized control trial comparing the intervention game to an placebo 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 real-world social interactions between dyads. The aims are evaluating 1) changes in the target mechanisms (social attention to faces, sensitivity to eye gaze cues) for the intervention relative to active control group, 2) engagement of intermediate mechanisms, including face-processing behaviors and real-world social communication behaviors, and 3) the relation between engagement of the target and intermediate mechanisms and symptom outcomes. Evidence of changes in autism social symptoms resulting from changing visual attention to faces and/or improved ability to understand eye gaze cues will provide clear evidence to inform a "go" decision about the therapeutic target for further clinical development.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD),

2. parent/caregiver and adolescent with ASD both native English speakers,

3. adolescent with ASD aged between 10-18 years at pre-test,

4. adolescent has normal vision and hearing with correction as reported by caregiver,

5. adolescent is able to use a computer for the purposes of game play,

6. adolescent scores < 80% correct (i.e., 0.5 SD less than Mean of typically developing adolescents) on online eye gaze screening task,

7. 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);

8. Full Scale IQ of adolescent determined to be between 70-130;

9. reading ability of adolescent determined to be at least a 2nd grade level;

10. adolescent is capable of cooperating with testing;

11. parent/caregiver and adolescent both consent/assent to participate in the research.

Exclusion Criteria:

1. having seizures within the previous two years

2. no stable internet connection in the home

3. refusing to consent/assent to take part in the research

4. 18 and have a legal guardian, which prohibits them from legally consenting for themselves

5. 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Intervention Video Game
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.
• Placebo Control Game
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.

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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
Primary	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	Intermediate Face Processing Mechanisms - Face Identity (CFMT)	Accuracy in face recognition will be assessed via standardized measures including Cambridge face memory task (CFMT) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Secondary	Intermediate Face Processing Mechanisms - Object Identity (CBMT)	Accuracy in object recognition will be assessed via standardized measures including Cambridge bike memory task (CBMT) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Secondary	Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)	Accuracy in face expression identification will be assessed via standardized measures including the face portion of the Cambridge Affective Memory task (CAM) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Secondary	Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)	Accuracy in face expression identification will be assessed via standardized measures including the face portion of the Reading the Mind in the Eyes Test (RMET) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Secondary	Face-to-Face Social Interactions - Visual Fixations	Eye tracking measures (ie visual fixations) will be collected during a naturalistic social conversation. Additionally, eye tracking measures will be collected during an interactive cued eye gaze task, which requires participants to select the object that a real person is looking at. These measures will be assessed at multiple time points including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months