An interventional study of Networked Peer Support with Peer Guide and Networked Peer Support with Clinician Coach in Depression, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 40 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
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.
Behavioral: 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 clinician coach.
Behavioral: Networked Peer Support with Clinician Coach
Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.
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.
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.
Program Logins Per Participant by Week.
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.
Time frame: Weeks 1-8
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
A 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.
Time frame: Week 4 and Week 8
SUS (System Usability Scale) Questionnaire
The 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.
Time frame: Week 4 and Week 8
| Milestone | Networked Peer Support With Peer Guide | Networked Peer Support With Clinician Coach |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 19 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| number of program logins | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach |
|---|---|---|
| Week 1 | 9.15 ± 4.12 | 8.17 ± 4.02 |
| Week 2 | 3.6 ± 2.91 | 6.06 ± 6.48 |
| Week 3 | 2.8 ± 2.12 | 3.39 ± 2.62 |
| Week 4 | 2.8 ± 2.44 | 2.44 ± 2.55 |
| Week 5 | 2.6 ± 2.01 | 2.28 ± 1.87 |
| Week 6 | 2.05 ± 1.9 | 2.33 ± 2.57 |
| Week 7 | 1.7 ± 1.75 | 1.11 ± 1.84 |
| Week 8 | 1.95 ± 2.31 | 1.22 ± 1.4 |
A 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.
| units on a scale | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach |
|---|---|---|
| Usefulness at Week 4 | 4.04 ± 1.73 | 4.4 ± 1.01 |
| Usefulness at Week 8 | 4.36 ± 1.62 | 4.53 ± 0.97 |
| Ease of Learning at Week 4 | 5.21 ± 2.07 | 5.55 ± 1.4 |
| Ease of Learning at Week 8 | 5.73 ± 1.25 | 5.38 ± 1.53 |
| Ease of Use at Week 4 | 4.79 ± 1.95 | 5.15 ± 1.28 |
| Ease of Use at Week 8 | 4.96 ± 1.27 | 5.03 ± 1.44 |
| Satisfaction at Week 4 | 4.18 ± 2.04 | 4.2 ± 1.44 |
| Satisfaction at Week 8 | 4.23 ± 2.01 | 4.29 ± 1.27 |
The 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.
| units on a scale | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach |
|---|---|---|
| SUS score at Week 4 | 61.53 ± 15.1 | 71.91 ± 18.74 |
| SUS score at Week 8 | 66.72 ± 14.82 | 69.53 ± 21.16 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 - Networked Peer Support With Peer Guide | — | 0/20 (0%) | 0/20 (0%) |
| Arm 2 - Networked Peer Support With Clinician Coach | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach | Total |
|---|---|---|---|
| Mean | 16.45 ± 0.999 | 16.0 ± 0.94 | 16.23 ± 0.99 |
| Sex/Gender, Customized(Participants) | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach | Total |
|---|---|---|---|
| Male | 6 | 3 | 9 |
| Female | 13 | 16 | 29 |
| Other | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 16 | 13 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm 1 - Networked Peer Support With Peer Guide | Arm 2 - Networked Peer Support With Clinician Coach | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 12 | 12 | 24 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 1 | 3 | 4 |
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