Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Preliminary change in parent/caregiver reported socialization on the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 |
Study investigators will preliminarily measure change in the Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver Comprehensive form. This will allow study team to understand if use of the mobile app as treatment is feasible. Scores from the socialization domain of the VABS-2 reflects one's functioning in social situations. The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (IQ) type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. |
Baseline (Week 0), Week 12 |
|
| Primary |
Mobile Application Usage |
Time (in seconds) of app use across the 12 weeks. |
Week 12 |
|
| Secondary |
Change in parent/caregiver reported social responsiveness from week 0 to week 12 |
The Social Responsiveness Scale-2 is a 65-item measure where parents/caregivers rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90). |
Baseline (Week 0), Week 12 |
|
| Secondary |
Change in mobile autism risk assessment score from week 0 to week 12 |
a level 2 screening tool that has been validated in several studies and that uses a brief parent/caregiver questionnaire with a 2 minute home video to generate a classification score that indicates severity of the autism phenotype (ranging from no autistic symptoms to severe autism) as well as confidence in the classification. |
Baseline (Week 0), Week 12 |
|
| Secondary |
Video Based Feature Analysis |
Shared videos will be evaluated for proper game play and enjoyment with the game across the 12 week period of the intervention. |
Week 12 |
|
| Secondary |
Change in Parent/Caregiver Confidence and Resources from baseline to week 12 |
Two 5 item questions regarding parent/caregiver confidence in their ability to manage their child's behaviors and adequacy of resources to manage their child's behaviors. |
Baseline (Week 0), Week 12 |
|
| Secondary |
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to week 12 |
The PSI-SF is a 36-item parent report scale that evaluates the extent and source of parent stress in the form of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36-180 with lower scores representing less parent stress. |
Baseline (Week 0), Week 12 |
|
| Secondary |
Engagement in gameplay across the 12 week period |
The Fun ToolKit and Child Engagement Scale will be adapted and combined to assess children's engagement and enjoyment while playing the app. |
Week 12 |
|
| Secondary |
Change in Emotion Recognition from baseline to week 12 |
Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will select 1 of 8 available Ekman emotion labels for 21 emotional face image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs. |
Baseline (Week 0), Week 12 |
|
| Secondary |
Changes in parent/caregiver reported eye contact and joint attention from week 0 to week 12 |
Parents/caregivers will rate their child's socially motivated eye contact and joint attention skills pre and post. This will be a 10 item measure. |
Baseline (Week 0), Week 12 |
|
| Secondary |
Change in NIH-Emotion Toolbox from baseline to Week 12 |
The NIH toolbox for emotion was developed to create a standardized, comprehensive, and concise battery of tests that can recognize the full spectrum of emotional experiences and their impacts on health and wellbeing. The NIH Toolbox for emotion includes 3 subdomains: negative affect, psychological well-being, and social relationships for children 3-7 years old. For the age range of 8-12 proxy measures are available for the same subdomains. |
Baseline (Week 0), Week 12 |
|
