AutismPhase 2SAGANCT02968225
Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
A Phase 2 study testing Computer Game in people with Autism, run by Penn State University at 1 site in United States.
Trial summary
The investigators hypothesize that this serious game (designed to provide a learning environment that maximizes opportunities for adolescents with autism to discover the functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to identify gazed-at objects, and will also lead to increased… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Autism
- What is being tested?
- Computer Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2018
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- parent/caregiver of an adolescent with a diagnosis of ASD,
- parent/caregiver and adolescent with ASD both native English speakers,
- adolescent with ASD aged between 10-18 years at enrollment,
- adolescent has normal vision and hearing with correction as indicated by parent report,
- adolescent is able to use a computer for the purposes of game play,
- adolescent scores > 80% correct (i.e., 0.5 SD less than M of TD adolescents) on online eye gaze screening task,
Show all 11Show fewer
- ASD diagnosis of adolescent confirmed in lab via the Autism Diagnostic Observation Schedule,
- Full Scale IQ of adolescent determined to be between 70-130 on the Kaufman Brief Intelligence Test,
- reading ability of adolescent determined to be at least a second grade level as assessed by the Oral and Written Language Scales,
- adolescent is capable of cooperating with testing,
- parent/caregiver and adolescent both consent/assent to participate in the research.
Who cannot join
- adolescent has had seizures within the previous two years,
- family lacks stable home internet,
- parent or adolescent refuses to consent/assent to take part in the research,
- adolescent is 18 and has a legal guardian, prohibiting him/her from legally consenting, or
- adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The investigators hypothesize that this serious game (designed to provide a learning environment that maximizes opportunities for adolescents with autism to discover the functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to identify gazed-at objects, and will also lead to increased social attention to faces in adolescents with autism. The investigators will test this hypothesis in a small-scale exploratory randomized control trial that will include both behavioral and eye tracking outcome measures.
- Conditions
- Autism
- Being tested
- Computer Game
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer GameBehavioural
The game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues.
| Study group | Role | What they receive |
|---|---|---|
| Computer Game | Experimental | All Computer Game participants will complete:
* online screening
* Diagnostic and eye-tracking pre-testing
* 2 month intervention
* Eye-tracking post-testing Receives: Behavioral: Computer Game |
| Waitlist control | No intervention | All Treatment as usual control participants will complete: * online screening * Diagnostic and eye-tracking pre-testing * Eye-tracking post-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Eye Gaze Following Task
Eye tracking and accuracy
Measured: 2 months
Dynamic Eye Gaze Following Task
Eye tracking and accuracy
Measured: 2 Months
Social/Visual Attention Task
Eye tracking
Measured: 2 Months
Secondary outcomes (4)
Social Responsiveness Scale
Parents completing measure of autism-like behavior in adolescents
Measured: 2 months
Social Skills Inventory System - Child version
Adolescents completing measure of social skills and problem behaviors in themselves
Measured: 2 months
Social Skills Inventory System - Adult version
Parents completing measure of social skills and problem behaviors in adolescents
Measured: 2 months
Treatment as Usual
Parents reporting on social and behavioral treatments adolescents receiving in and out of school
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized into intervention or standard care control conditions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968225
- Sponsor's protocol ID
- R61MH110624
- Acronym
- SAGA
- Status last verified
- Mar 2021
- First submitted
- 16 Nov 2016
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data will be shared in the NIMH National Data Archive
Publications
Scherf KS, Griffin JW, Geier CF, Smyth JM. Social visual attention as a treatment outcome: evaluating the social games for autistic adolescents (SAGA) intervention. Sci Rep. 2024 Jan 5;14(1):619. doi: 10.1038/s41598-024-51332-z.
PubMed 38182792Scherf KS, Griffin JW, Judy B, Whyte EM, Geier CF, Elbich D, Smyth JM. Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial. BMJ Open. 2018 Oct 4;8(9):e023682. doi: 10.1136/bmjopen-2018-023682.
PubMed 30287612
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
- ClinicalTrials.gov ID
- NCT02968225
- Acronym / sponsor ID
- SAGA / R61MH110624
- Conditions
- Autism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 18 Nov 2016 (estimated)
- 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 hypothesize that this serious game (designed to provide a learning environment that maximizes opportunities for adolescents with autism to discover the functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to identify gazed-at objects, and will also lead to increased social attention to faces in adolescents with autism. The investigators will test this hypothesis in a small-scale exploratory randomized control trial that will include both behavioral and eye tracking outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants randomized into intervention or standard care control conditions
| Arm | Type | Receives |
|---|---|---|
| Computer Game | Experimental | Behavioral: Computer GameAll Computer Game participants will complete: * online screening * Diagnostic and eye-tracking pre-testing * 2 month intervention * Eye-tracking post-testing |
| Waitlist control | No intervention | –All Treatment as usual control participants will complete: * online screening * Diagnostic and eye-tracking pre-testing * Eye-tracking post-testing |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- parent/caregiver of an adolescent with a diagnosis of ASD,
- parent/caregiver and adolescent with ASD both native English speakers,
- adolescent with ASD aged between 10-18 years at enrollment,
- adolescent has normal vision and hearing with correction as indicated by parent report,
- adolescent is able to use a computer for the purposes of game play,
Key exclusion criteria (5 listed)
- adolescent has had seizures within the previous two years,
- family lacks stable home internet,
- parent or adolescent refuses to consent/assent to take part in the research,
- adolescent is 18 and has a legal guardian, prohibiting him/her from legally consenting, or
- adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).
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 |
|---|---|---|
| Computer GameThe game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues. | Behavioural | Computer Game |
Primary outcome
Static Eye Gaze Following Task
Time frame: 2 months
Eye tracking and accuracy
Dynamic Eye Gaze Following Task
Time frame: 2 Months
Eye tracking and accuracy
Social/Visual Attention Task
Time frame: 2 Months
Eye tracking
4 secondary outcomes
Social Responsiveness Scale
Time frame: 2 months
Social Skills Inventory System - Child version
Time frame: 2 months
Social Skills Inventory System - Adult version
Time frame: 2 months
Treatment as Usual
Time frame: 2 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 5 Mar 2021.
- Derived from this study: PubMed 38182792Scherf KS, Griffin JW, Geier CF, Smyth JM. Social visual attention as a treatment outcome: evaluating the social games for autistic adolescents (SAGA) intervention. Sci Rep. 2024 Jan 5;14(1):619. doi: 10.1038/s41598-024-51332-z.
- Derived from this study: PubMed 30287612Scherf KS, Griffin JW, Judy B, Whyte EM, Geier CF, Elbich D, Smyth JM. Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial. BMJ Open. 2018 Oct 4;8(9):e023682. doi: 10.1136/bmjopen-2018-023682.
- Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be shared in the NIMH National Data Archive
Related trials for Autism
Recruiting
A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents
Autism Spectrum Disorders
Not yet recruiting
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Autism Spectrum Disorder, TMS
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
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, PhD 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 Phase 2 study testing Computer Game in people with 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 5 Mar 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Static Eye Gaze Following Task (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968225, which also lists 2 linked publications.
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 5 Mar 2021.