Using Serious Games to Improve Social Skills in Autism

NCT ID: NCT03690661

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2024-01-31

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.

Detailed 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.

Conditions

Autism Spectrum Disorder; Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Video Game

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

Group Type: EXPERIMENTAL

Intervention Video Game

Intervention Type: 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.

Control Video Game

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

Group Type: PLACEBO_COMPARATOR

Placebo Control Game

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

K. Suzanne Scherf

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzy Scherf

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

R33MH110624

Identifier Type: NIH

Identifier Source: secondary_id

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R33MH110624

Identifier Type: NIH

Identifier Source: org_study_id

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