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

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Depression
• Interventions: Behavioral: Networked Peer Support with Peer Guide; Behavioral: Networked Peer Support with Clinician Coach
• Enrollment: 40

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Networked Peer Support With Peer Guide	Networked Peer Support With Clinician Coach
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	20	20
Completed	20	19
Not Completed	0	1
Reason Not Completed
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		20	19	39
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	20 participants	19 participants	39 participants
		16.45 (0.999)	16.0 (0.94)	16.23 (0.99)
Sex/Gender, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	20 participants	19 participants	39 participants
Male		6 30.0%	3 15.8%	9 23.1%
Female		13 65.0%	16 84.2%	29 74.4%
Other		1 5.0%	0 0.0%	1 2.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	Hispanic or Latino	4 20.0%	6 31.6%	10 25.6%
	Not Hispanic or Latino	16 80.0%	13 68.4%	29 74.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	3 15.0%	1 5.3%	4 10.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 10.0%	1 5.3%	3 7.7%
	White	12 60.0%	12 63.2%	24 61.5%
	More than one race	2 10.0%	2 10.5%	4 10.3%
	Unknown or Not Reported	1 5.0%	3 15.8%	4 10.3%

Outcome Measures

1. Primary Outcome

Title	Program Logins Per Participant by Week.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
Arm/Group Description:	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.	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 Number of Participants Analyzed	20	19
Mean (Standard Deviation); Unit of Measure: number of program logins
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)

2. Primary Outcome

Title	USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
Arm/Group Description:	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.	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 Number of Participants Analyzed	20	19
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

3. Primary Outcome

Title	SUS (System Usability Scale) Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
Arm/Group Description:	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.	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 Number of Participants Analyzed	20	19
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
Arm/Group Description	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.	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.
All-Cause Mortality
	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1 - Networked Peer Support With Peer Guide	Arm 2 - Networked Peer Support With Clinician Coach
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: David C. Mohr, PhD
• Organization: Northwestern University
• Phone: 312-503-1403
• EMail: d-mohr@northwestern.edu

• Responsible Party: David Mohr, Northwestern University
• ClinicalTrials.gov Identifier: NCT01912729
• Other Study ID Numbers: P20MH090318 STU00056069-FTPT; P20MH090318 ( U.S. NIH Grant/Contract )
• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Results First Submitted: August 2, 2017
• Results First Posted: November 21, 2018
• Last Update Posted: December 13, 2018