Trial Outcomes & Findings for Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study (NCT NCT04326231)
NCT ID: NCT04326231
Last Updated: 2023-09-21
Results Overview
Change was calculated on an average from all relevant time points used in the calculation in the Time Frame ( baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment); These measures were not completed due to COVID Change in scores on the Vineland-3 domain level caregiver report social skills and relationships, measures of usability. Qualitative descriptors: scores of 1 to 17 may be considered Average, 18 to 20 Elevated, and 21 to 24 Clinically Significant Caregivers partially completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study. 0 Caregivers had their scores analyzed as they were unable to complete the study due to COVID, this study was terminated.
TERMINATED
NA
10 participants
Enrollment, baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment; These measures were not completed due to COVID
2023-09-21
Participant Flow
Withdrawn (limited recruitment within study timeline)
The protocol enrollment number represents Child/Caregiver enrollment in the study.
Participant milestones
| Measure |
Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device: Usability assessment of Cognoa ASD Therapeutic Device
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device: Usability assessment of Cognoa ASD Therapeutic Device
|
|---|---|
|
Overall Study
COVID Withdrawn (limited recruitment within study timeline)
|
10
|
Baseline Characteristics
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Enrollment, baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment; These measures were not completed due to COVIDPopulation: 0 Caregivers completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study. This study was terminated. Data were not collected due to early termination of the study.
Change was calculated on an average from all relevant time points used in the calculation in the Time Frame ( baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment); These measures were not completed due to COVID Change in scores on the Vineland-3 domain level caregiver report social skills and relationships, measures of usability. Qualitative descriptors: scores of 1 to 17 may be considered Average, 18 to 20 Elevated, and 21 to 24 Clinically Significant Caregivers partially completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study. 0 Caregivers had their scores analyzed as they were unable to complete the study due to COVID, this study was terminated.
Outcome measures
Outcome data not reported
Adverse Events
Primary
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place