Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Networked Peer Support with Peer Guide Behavioral: Networked Peer Support with Clinician Coach Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
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.
 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.
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) .
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912729


Locations
Layout table for location information
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: David C Mohr, Ph.D Northwestern University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01912729    
Other Study ID Numbers: P20MH090318 STU00056069-FTPT
P20MH090318 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2013    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by David Mohr, Northwestern University:
Depression prevention
Technology Assisted
Adolescents
Peer networked
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders