Trial Outcomes & Findings for Technology Assisted Programs That Promote Mental Health for Teenagers (NCT NCT01912729)
NCT ID: NCT01912729
Last Updated: 2018-12-13
Results Overview
Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Weeks 1-8
Results posted on
2018-12-13
Participant Flow
Participant milestones
| Measure |
Networked Peer Support With Peer Guide
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Networked Peer Support With Clinician Coach
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Networked Peer Support With Peer Guide
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Networked Peer Support With Clinician Coach
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Technology Assisted Programs That Promote Mental Health for Teenagers
Baseline characteristics by cohort
| Measure |
Arm 1 - Networked Peer Support With Peer Guide
n=20 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Arm 2 - Networked Peer Support With Clinician Coach
n=19 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.45 years
STANDARD_DEVIATION 0.999 • n=5 Participants
|
16.0 years
STANDARD_DEVIATION 0.94 • n=7 Participants
|
16.23 years
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-8Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
Outcome measures
| Measure |
Arm 1 - Networked Peer Support With Peer Guide
n=20 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Arm 2 - Networked Peer Support With Clinician Coach
n=19 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
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|---|---|---|
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Program Logins Per Participant by Week.
Week 1
|
9.15 number of program logins
Standard Deviation 4.12
|
8.17 number of program logins
Standard Deviation 4.02
|
|
Program Logins Per Participant by Week.
Week 4
|
2.8 number of program logins
Standard Deviation 2.44
|
2.44 number of program logins
Standard Deviation 2.55
|
|
Program Logins Per Participant by Week.
Week 5
|
2.6 number of program logins
Standard Deviation 2.01
|
2.28 number of program logins
Standard Deviation 1.87
|
|
Program Logins Per Participant by Week.
Week 2
|
3.6 number of program logins
Standard Deviation 2.91
|
6.06 number of program logins
Standard Deviation 6.48
|
|
Program Logins Per Participant by Week.
Week 3
|
2.8 number of program logins
Standard Deviation 2.12
|
3.39 number of program logins
Standard Deviation 2.62
|
|
Program Logins Per Participant by Week.
Week 6
|
2.05 number of program logins
Standard Deviation 1.9
|
2.33 number of program logins
Standard Deviation 2.57
|
|
Program Logins Per Participant by Week.
Week 7
|
1.7 number of program logins
Standard Deviation 1.75
|
1.11 number of program logins
Standard Deviation 1.84
|
|
Program Logins Per Participant by Week.
Week 8
|
1.95 number of program logins
Standard Deviation 2.31
|
1.22 number of program logins
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Week 4 and Week 8A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree. Lund, A.M., 2001. Measuring Usability with the USE Questionnaire.
Outcome measures
| Measure |
Arm 1 - Networked Peer Support With Peer Guide
n=20 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Arm 2 - Networked Peer Support With Clinician Coach
n=19 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
|
|---|---|---|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Usefulness at Week 8
|
4.36 units on a scale
Standard Deviation 1.62
|
4.53 units on a scale
Standard Deviation 0.97
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Ease of Learning at Week 4
|
5.21 units on a scale
Standard Deviation 2.07
|
5.55 units on a scale
Standard Deviation 1.4
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Ease of Learning at Week 8
|
5.73 units on a scale
Standard Deviation 1.25
|
5.38 units on a scale
Standard Deviation 1.53
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Ease of Use at Week 4
|
4.79 units on a scale
Standard Deviation 1.95
|
5.15 units on a scale
Standard Deviation 1.28
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Ease of Use at Week 8
|
4.96 units on a scale
Standard Deviation 1.27
|
5.03 units on a scale
Standard Deviation 1.44
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Satisfaction at Week 4
|
4.18 units on a scale
Standard Deviation 2.04
|
4.2 units on a scale
Standard Deviation 1.44
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Satisfaction at Week 8
|
4.23 units on a scale
Standard Deviation 2.01
|
4.29 units on a scale
Standard Deviation 1.27
|
|
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Usefulness at Week 4
|
4.04 units on a scale
Standard Deviation 1.73
|
4.4 units on a scale
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: Week 4 and Week 8The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Outcome measures
| Measure |
Arm 1 - Networked Peer Support With Peer Guide
n=20 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
|
Arm 2 - Networked Peer Support With Clinician Coach
n=19 Participants
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
|
|---|---|---|
|
SUS (System Usability Scale) Questionnaire
SUS score at Week 4
|
61.53 units on a scale
Standard Deviation 15.1
|
71.91 units on a scale
Standard Deviation 18.74
|
|
SUS (System Usability Scale) Questionnaire
SUS score at Week 8
|
66.72 units on a scale
Standard Deviation 14.82
|
69.53 units on a scale
Standard Deviation 21.16
|
Adverse Events
Arm 1 - Networked Peer Support With Peer Guide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 - Networked Peer Support With Clinician Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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