ProjectTECH: Technology Assisted Programs That Promote Mental Health for Teenagers

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01912729
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 6
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

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

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts 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) .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• First Posted: Jul 31, 2013
• Last Update Posted: Dec 13, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University: Depression prevention; Technology Assisted; Adolescents; Peer networked
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

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

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 Participants	20	19	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.45 (0.999)	16.0 (0.94)	16.23 (0.99)
Sex/Gender, Customized (Count of Participants)
Male	6 30%	3 15.8%	9 23.1%
Female	13 65%	16 84.2%	29 74.4%
Other	1 5%	0 0%	1 2.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 20%	6 31.6%	10 25.6%
Not Hispanic or Latino	16 80%	13 68.4%	29 74.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 15%	1 5.3%	4 10.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 10%	1 5.3%	3 7.7%
White	12 60%	12 63.2%	24 61.5%
More than one race	2 10%	2 10.5%	4 10.3%
Unknown or Not Reported	1 5%	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.
Measure Participants	20	19
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.
Measure Participants	20	19
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.
Measure Participants	20	19
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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 - Networked Peer Support With Peer Guide		Arm 2 - Networked Peer Support With Clinician Coach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - Networked Peer Support With Peer Guide		Arm 2 - Networked Peer Support With Clinician Coach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.