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Brief Online Help-seeking Barrier Reduction Intervention

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ClinicalTrials.gov Identifier: NCT03633825
Recruitment Status : Completed
First Posted : August 16, 2018
Results First Posted : April 17, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Jaroszewski, Harvard University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Crisis Intervention
Suicide and Depression
Intervention Behavioral: Brief help-seeking barrier reduction intervention
Enrollment 39450
Recruitment Details Participants were recruited from 39,450 Koko users who signed up for the service between August 10, 2017 and September 20, 2017. Koko (née Panoply) provides safety services for large online social networks.
Pre-assignment Details All potential participants (N=39,450) screened for eligibility were considered enrolled. Potential participants were randomized upon accessing the platform, not later when identified as being in-crisis, because we used the platform’s extant, AB-testing randomization tool. No other AB-tests were on the platform during the study period.
Arm/Group Title Control Intervention
Hide Arm/Group Description Control Condition: Users in the control condition experienced the Koko digital platform as usual. Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a previous study among Koko users found that a common concern was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
Period Title: Enrollment
Started [1] 19838 19612
Completed 805 775
Not Completed 19033 18837
Reason Not Completed
Did not post on network             5066             5080
Post not classified as crisis             13967             13757
[1]
Randomized and assessed for eligibility.
Period Title: Allocation
Started [1] 805 775
Completed 805 775
Not Completed 0 0
[1]
Allocated and received intervention.
Period Title: Follow up
Started 805 775
Completed 327 325
Not Completed 478 450
Reason Not Completed
Lost to Follow-up             478             450
Period Title: Analysis
Started 327 325
Completed 327 325
Not Completed 0 0
Arm/Group Title Control Intervention Total
Hide Arm/Group Description Control Condition: Users in the control condition experienced the Koko digital platform as usual. Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users. Total of all reporting groups
Overall Number of Baseline Participants 805 775 1580
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Description: Participant age was not collected.
[2]
Measure Analysis Population Description: Age was not collected.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0 0 0
Male 0 0 0
[1]
Measure Description: Participant sex was not collected.
[2]
Measure Analysis Population Description: Sex was not collected.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Description: Participant region of enrollment was not collected.
[2]
Measure Analysis Population Description: Region of Enrollment was not collected.
1.Primary Outcome
Title Number of Participants Reporting Use of Crisis-referrals
Hide Description The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline)
Time Frame 5 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
Control Condition: Users in the control condition experienced the Koko digital platform as usual.
Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
Overall Number of Participants Analyzed 327 325
Measure Type: Count of Participants
Unit of Measure: Participants
130
  39.8%
159
  48.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.03 to 1.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good"
Hide Description The number of participants in the treatment versus control conditions reporting that their experience on the Koko digital platform was "good" versus "bad" using a two-option response question.
Time Frame 5 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
Control Condition: Users in the control condition experienced the Koko digital platform as usual.
Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
Overall Number of Participants Analyzed 327 325
Measure Type: Count of Participants
Unit of Measure: Participants
250
  76.5%
234
  72.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.19
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.91 to 1.59
Estimation Comments [Not Specified]
Time Frame 31 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Intervention
Hide Arm/Group Description Control Condition: Users in the control condition experienced the Koko digital platform as usual. Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/805 (0.00%)   0/775 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/805 (0.00%)   0/775 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/805 (0.00%)   0/775 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: Harvard University
Phone: 617-496-4484
EMail: jaroszewski@fas.harvard.edu
Layout table for additonal information
Responsible Party: Adam Jaroszewski, Harvard University
ClinicalTrials.gov Identifier: NCT03633825     History of Changes
Other Study ID Numbers: IRB17-1303
First Submitted: August 14, 2018
First Posted: August 16, 2018
Results First Submitted: August 17, 2018
Results First Posted: April 17, 2019
Last Update Posted: August 12, 2019