Trial Outcomes & Findings for Brief Online Help-seeking Barrier Reduction Intervention (NCT NCT03633825)

NCT ID: NCT03633825

Last Updated: 2023-04-12

Results Overview

The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39450 participants
• Primary outcome timeframe: 5 hours post intervention
• Results posted on: 2023-04-12

Participant Flow

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.

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.

Participant milestones

Measure	Control Control Condition: Users in the control condition experienced the Koko digital platform as usual.	Intervention 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.
Enrollment STARTED	19838	19612
Enrollment COMPLETED	805	775
Enrollment NOT COMPLETED	19033	18837
Allocation STARTED	805	775
Allocation COMPLETED	805	775
Allocation NOT COMPLETED	0	0
Follow up STARTED	805	775
Follow up COMPLETED	327	325
Follow up NOT COMPLETED	478	450
Analysis STARTED	327	325
Analysis COMPLETED	327	325
Analysis NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Control Control Condition: Users in the control condition experienced the Koko digital platform as usual.	Intervention 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.
Enrollment Did not post on network	5066	5080
Enrollment Post not classified as crisis	13967	13757
Follow up Lost to Follow-up	478	450

Baseline Characteristics

Age was not collected.

Baseline characteristics by cohort

Measure	Control n=805 Participants Control Condition: Users in the control condition experienced the Koko digital platform as usual.	Intervention n=775 Participants 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 n=1580 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants Sex was not collected.	0 Participants Sex was not collected.	0 Participants Sex was not collected.
Sex: Female, Male Male	0 Participants Sex was not collected.	0 Participants Sex was not collected.	0 Participants Sex was not collected.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 5 hours post intervention

The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline)

Outcome measures

Measure	Control n=327 Participants Control Condition: Users in the control condition experienced the Koko digital platform as usual.	Intervention n=325 Participants 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.
Number of Participants Reporting Use of Crisis-referrals	130 Participants	159 Participants

SECONDARY outcome

Timeframe: 5 hours post intervention

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.

Outcome measures

Measure	Control n=327 Participants Control Condition: Users in the control condition experienced the Koko digital platform as usual.	Intervention n=325 Participants 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.
Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good"	250 Participants	234 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Harvard University

Phone: 617-496-4484

Email: jaroszewski@fas.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place