Autism Spectrum DisorderSAGANCT03690661
Using Serious Games to Improve Social Skills in Autism
A study testing Intervention Video Game in people with Autism Spectrum Disorder and Autism, run by Penn State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Intervention Video Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- having seizures within the previous two years
- no stable internet connection in the home
- refusing to consent/assent to take part in the research
- 18 and have a legal guardian, which prohibits them from legally consenting for themselves
- 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the 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
- Being tested
- Intervention Video Game, Placebo Control Game
- Keywords
- adolescent, face, social skills, video game
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Facies, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Video GameBehavioural
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 GameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Placebo Control Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Secondary outcomes (5)
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).
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Dec 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, K. Suzanne Scherf, Penn State University
- Investigators
- Suzy Scherf, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690661
- Sponsor's protocol ID
- R33MH110624
- Other IDs
- R33MH110624
- Acronym
- SAGA
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2018
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be invited to share de-identified data acquired from this study with the National Institutes of Health Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Serious Games to Improve Social Skills in Autism
- ClinicalTrials.gov ID
- NCT03690661
- Acronym / sponsor ID
- SAGA / R33MH110624
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- adolescent, face, social skills, video game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Video Game | Experimental | Behavioral: Intervention Video GameParticipants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session |
| Control Video Game | Placebo comparator | Behavioral: Placebo Control GameParticipants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (5 listed)
- having seizures within the previous two years
- no stable internet connection in the home
- refusing to consent/assent to take part in the research
- 18 and have a legal guardian, which prohibits them from legally consenting for themselves
- 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Video GameThe 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. | Behavioural | Intervention Video Game |
| Placebo Control GameThe 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. | Behavioural | Control Video Game |
Primary outcome
Primary Target Eye Gaze Mechanisms - Performance Accuracy
Time frame: 6 months
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).
Primary Target Eye Gaze Mechanisms - Visual Fixation
Time frame: 6 months
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).
Social Symptoms - Social Skills Inventory System (SSIS)
Time frame: 6 months
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).
Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)
Time frame: 6 months
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).
5 secondary outcomes
Intermediate Face Processing Mechanisms - Face Identity (CFMT)
Time frame: 6 months
Intermediate Face Processing Mechanisms - Object Identity (CBMT)
Time frame: 6 months
Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)
Time frame: 6 months
Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)
Time frame: 6 months
Face-to-Face Social Interactions - Visual Fixations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Yes. Participants will be invited to share de-identified data acquired from this study with the National Institutes of Health Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzy Scherf principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Video Game in people with Autism Spectrum Disorder and Autism, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Target Eye Gaze Mechanisms - Performance Accuracy (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.