Technology Assisted Programs That Promote Mental Health for Teenagers (ProjectTECH)

• ClinicalTrials.gov Identifier: NCT01912729
• Recruitment Status: Completed
• First Posted: July 31, 2013
• Results First Posted: November 21, 2018
• Last Update Posted: December 13, 2018
• Sponsor: Northwestern University
• Information provided by (Responsible Party): David Mohr, Northwestern University

Tracking Information

• First Submitted Date: July 29, 2013
• First Posted Date: July 31, 2013
• Results First Submitted Date: August 2, 2017
• Results First Posted Date: November 21, 2018
• Last Update Posted Date: December 13, 2018
• Study Start Date: January 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2018)

• Program Logins Per Participant by Week. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: July 30, 2013)

• Depression [ Time Frame: Throughout participation, lasting up to 26 weeks ]
  Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) and depression module of the Mini Internaitonal Neuropsychiatric Interview for Children and Adolescents (MINIKid)
• Usability of the program [ Time Frame: Throughout participation, lasting up to 26 weeks ]
  Usability of the program as measured by the Usefulness, Satisfaction, and Ease of Use (USE) survey.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Technology Assisted Programs That Promote Mental Health for Teenagers
• Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Depression

Intervention

• Behavioral: 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.
• Behavioral: 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.

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Networked Peer Support with Peer Guide
• Experimental: 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.
  Intervention: Behavioral: Networked Peer Support with Clinician Coach
• No Intervention: Wait List Control
  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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2018): 40
• Original Estimated Enrollment (submitted: July 30, 2013): 100
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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) .

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01912729
• Other Study ID Numbers: P20MH090318 STU00056069-FTPT; P20MH090318 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: David Mohr, Northwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David C Mohr, Ph.D; Northwestern University

• PRS Account: Northwestern University
• Verification Date: November 2018