Trial Outcomes & Findings for Development of a Mobile App for an Executive Functioning Intervention for Adolescents (NCT NCT04018794)
NCT ID: NCT04018794
Last Updated: 2021-11-23
Results Overview
10-item technology-agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess system usability at post-treatment (month 3).
COMPLETED
NA
15 participants
at month 3 (1-month post-intervention)
2021-11-23
Participant Flow
All participants were recruited from local schools and enrolled were assigned to a single-arm/group where they all evaluated the usability and feasibility of the ATOM intervention tool as designed. Ratings of usability and feasibility were collected before and after using the ATOM tool.
All participants were assigned to a single-arm/group where they all evaluated the usability and feasibility of the ATOM intervention tool as designed. None were excluded upon enrollment.
Participant milestones
| Measure |
Behavioral/Organizational Skills Intervention Plus Mobile App
Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)
Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Mobile App for an Executive Functioning Intervention for Adolescents
Baseline characteristics by cohort
| Measure |
Behavioral/Organizational Skills Intervention Plus Mobile App
n=15 Participants
Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)
Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at month 3 (1-month post-intervention)10-item technology-agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess system usability at post-treatment (month 3).
Outcome measures
| Measure |
Behavioral/Organizational Skills Intervention Plus Mobile App
n=15 Participants
Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)
Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
|
|---|---|
|
System Usability Scale
|
71 score on a scale
Interval 40.0 to 100.0
|
PRIMARY outcome
Timeframe: at month 3 (1-month post-intervention)8-item Stakeholder Feasibility and Usability Rating (SFUR) was used to assess stakeholders' perceptions of the overall feasibility and usability of the program. The SFUR score is a mean of all items and ranges from 1 to 5, with higher scores indicating higher feasibility and usability. This measure was developed for the present study. The present study will assess these feasibility ratings at post-treatment (month 3).
Outcome measures
| Measure |
Behavioral/Organizational Skills Intervention Plus Mobile App
n=15 Participants
Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)
Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
|
|---|---|
|
Post Stakeholder Feasibility and Usability Rating
|
4.3 units on a scale
Interval 1.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline (month 0) to Post-Intervention (3 months)SCA-PI (Hoagwood et al., 2004) will assess medication and psychosocial treatment use and changes in use including any school (e.g., Daily Report Card) or community services during the study from baseline/pre-treatment (month 0) to post-intervention (3 months).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (month 0)A background form will collect information sufficient to calculate Hollingshead Socioeconomic Index as well as family income, marital status, and child's developmental and psychiatric history. Teachers and SMHPs will also complete a brief demographic form to assess age, race, and experience.
Outcome measures
Outcome data not reported
Adverse Events
Behavioral/Organizational Skills Intervention Plus Mobile App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Melissa Dvorsky
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place