Depression
Conditions
Keywords
Depression prevention, Technology Assisted, Adolescents, Peer networked
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALNetworked 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.
BEHAVIORALNetworked 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.
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS). * Is familiar with the use of computers and the Internet, as well as mobile phones * Is able to speak and read English * Is between 14-19 years of age
Exclusion criteria
* Is currently taking an antidepressant medication or has taken one in the previous 3 months * Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone * Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis. * Is severely suicidal (has ideation, plan, and intent in the past 12 months) .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Logins Per Participant by Week. | Weeks 1-8 | 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. |
| USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Week 4 and Week 8 | 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. |
| SUS (System Usability Scale) Questionnaire | Week 4 and Week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - 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. | 20 |
| Arm 2 - 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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 1 - Networked Peer Support With Peer Guide | Total | Arm 2 - Networked Peer Support With Clinician Coach |
|---|---|---|---|
| Age, Continuous | 16.45 years STANDARD_DEVIATION 0.999 | 16.23 years STANDARD_DEVIATION 0.99 | 16.0 years STANDARD_DEVIATION 0.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 29 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Sex/Gender, Customized Female | 13 Participants | 29 Participants | 16 Participants |
| Sex/Gender, Customized Male | 6 Participants | 9 Participants | 3 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 1 | 9.15 number of program logins | Standard Deviation 4.12 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 2 | 3.6 number of program logins | Standard Deviation 2.91 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 3 | 2.8 number of program logins | Standard Deviation 2.12 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 4 | 2.8 number of program logins | Standard Deviation 2.44 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 5 | 2.6 number of program logins | Standard Deviation 2.01 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 6 | 2.05 number of program logins | Standard Deviation 1.9 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 7 | 1.7 number of program logins | Standard Deviation 1.75 |
| Arm 1 - Networked Peer Support With Peer Guide | Program Logins Per Participant by Week. | Week 8 | 1.95 number of program logins | Standard Deviation 2.31 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 8 | 1.22 number of program logins | Standard Deviation 1.4 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 1 | 8.17 number of program logins | Standard Deviation 4.02 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 5 | 2.28 number of program logins | Standard Deviation 1.87 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 2 | 6.06 number of program logins | Standard Deviation 6.48 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 7 | 1.11 number of program logins | Standard Deviation 1.84 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 3 | 3.39 number of program logins | Standard Deviation 2.62 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 6 | 2.33 number of program logins | Standard Deviation 2.57 |
| Arm 2 - Networked Peer Support With Clinician Coach | Program Logins Per Participant by Week. | Week 4 | 2.44 number of program logins | Standard Deviation 2.55 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Networked Peer Support With Peer Guide | SUS (System Usability Scale) Questionnaire | SUS score at Week 4 | 61.53 units on a scale | Standard Deviation 15.1 |
| Arm 1 - Networked Peer Support With Peer Guide | SUS (System Usability Scale) Questionnaire | SUS score at Week 8 | 66.72 units on a scale | Standard Deviation 14.82 |
| Arm 2 - Networked Peer Support With Clinician Coach | SUS (System Usability Scale) Questionnaire | SUS score at Week 4 | 71.91 units on a scale | Standard Deviation 18.74 |
| Arm 2 - Networked Peer Support With Clinician Coach | SUS (System Usability Scale) Questionnaire | SUS score at Week 8 | 69.53 units on a scale | Standard Deviation 21.16 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Usefulness at Week 8 | 4.36 units on a scale | Standard Deviation 1.62 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Use at Week 8 | 4.96 units on a scale | Standard Deviation 1.27 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Learning at Week 8 | 5.73 units on a scale | Standard Deviation 1.25 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Satisfaction at Week 4 | 4.18 units on a scale | Standard Deviation 2.04 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Learning at Week 4 | 5.21 units on a scale | Standard Deviation 2.07 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Use at Week 4 | 4.79 units on a scale | Standard Deviation 1.95 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Satisfaction at Week 8 | 4.23 units on a scale | Standard Deviation 2.01 |
| Arm 1 - Networked Peer Support With Peer Guide | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Usefulness at Week 4 | 4.04 units on a scale | Standard Deviation 1.73 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Satisfaction at Week 8 | 4.29 units on a scale | Standard Deviation 1.27 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Usefulness at Week 4 | 4.4 units on a scale | Standard Deviation 1.01 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Learning at Week 4 | 5.55 units on a scale | Standard Deviation 1.4 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Learning at Week 8 | 5.38 units on a scale | Standard Deviation 1.53 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Use at Week 4 | 5.15 units on a scale | Standard Deviation 1.28 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Ease of Use at Week 8 | 5.03 units on a scale | Standard Deviation 1.44 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Satisfaction at Week 4 | 4.2 units on a scale | Standard Deviation 1.44 |
| Arm 2 - Networked Peer Support With Clinician Coach | USE (Usefulness, Satisfaction and Ease of Use) Questionnaire | Usefulness at Week 8 | 4.53 units on a scale | Standard Deviation 0.97 |