Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Artifact removal |
Number of artifacts detected during the testing period |
through study participation, an average of 3 months |
|
| Other |
Offline mode activations |
Proportion of time offline mode is activated over the testing week based on accelerometry data threshold |
through study participation, an average of 3 months |
|
| Other |
Clinical decision support success |
Proportion of alarms/emotion regulation strategy app push notifications that result in timely strategy implementation, as measured during the observation session |
through study participation, an average of 3 months |
|
| Other |
False positives/negatives |
Proportion of alarms that appear not to be associated with an oncoming challenging behavior (e.g. due to child movement)/challenging behaviors that occurred without an alarm, measured during the observation session |
through study participation, an average of 3 months |
|
| Primary |
System Usability Scale (SUS) |
The System Usability Scale (SUS) measures perceptions of usability of a given system, in this case, the KeepCalm app. The scale consists of 10 items, each rated on a 5-point Likert Scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Responses are transformed to get a total range of possible values from 0-100, with higher scores indicating higher perceptions of usability. Typically, a score above 68 is regarded as a good score. |
3 months post-baseline |
|
| Primary |
Acceptability of Intervention Measure (AIM) |
The Acceptability of Intervention Measure (AIM) is used to measure the acceptability of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater acceptability of the intervention. |
3 months post-baseline |
|
| Primary |
Feasibility of Intervention Measure (FIM) |
The Feasibility of Intervention Measure (FIM) is used to measure the feasibility of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater feasibility of the intervention. |
3 months post-baseline |
|
| Primary |
Intervention Appropriateness Measure (IAM) |
The Intervention Appropriateness Measure (IAM) is used to measure the appropriateness of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater appropriateness of the intervention. |
3 months post-baseline |
|
| Primary |
Qualitative interview |
This interview will assess the intervention's usability, appropriateness, feasibility, and acceptability in a qualitative interview format. |
3 months post-baseline |
|
| Secondary |
School Situations Questionnaire (SSQ) |
The School Situations Questionnaire (SSQ) assessing challenging behaviors within the context of school. The scale assesses both the presence and the severity of challenging behaviors by asking the teacher whether or not a given behavior occurs for that child and to rate the severity. The scale yields two summary scores. The first is the number of problems score which is a sum of the number of problems endorsed, ranging from 0-8 with higher scores indicating greater problems endorsed. The second is the mean severity, calculated as the mean severity for the items endorsed, ranging from 1 to 9 with higher numbers indicating more severe problems. |
baseline and 3 months post-baseline |
|
| Secondary |
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) |
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) measures the frequency and severity of aggressive behavior episodes. The scale is divided into four components: verbal aggression, aggression against property, autoaggression, and physical aggression. There are 4 items in each category, scored from 0-4 (with higher numbers indicating greater severity) and raters can select as many items as are relevant in the category. The items are then summed within each category to create a summed category score, and then each category is multiplied by its specified weight to give a total weighted aggression score, ranging from 0 to 100, with higher scores indicating greater problems with aggression. |
baseline and 3 months post-baseline |
|
| Secondary |
Emotion Dysregulation Inventory (EDI) |
The Emotion Dysregulation Inventory (EDI) measures emotion dysregulation by asking raters to identify how much of a problem certain emotions and behaviors are for the person being rated. The scale consists of 66 items that are rated for how much of a problem the behavior has been in the last 7 days ("not at all", "mild", "moderate", "severe", "very severe"). This ratings are converted into a numerical rating from 0 ("not at all") to 4 ("very severe"), and then summed to create a total score ranging from 0-264, which higher scores indicating greater emotion dysregulation. |
baseline and 3 months post-baseline |
|
