Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective: Mental illness is a leading cause of disease burden; however, many barriers prevent people from seeking mental health services. Technological innovations may improve the ability to reach under-served populations by overcoming many existing barriers. The investigators evaluated a brief, automated risk assessment and intervention platform designed to increase the use of crisis resources provided to individuals who were online and in crisis. Hypothesis: The investigators hypothesized that individuals assigned to the intervention condition would report using crisis resources at higher rates than individuals in the control condition. Method: Participants, users of the digital mental health app Koko, were randomly assigned to treatment or control conditions upon accessing the app and were included in the study after their posts were identified by machine learning classifiers as signaling a current mental health crisis. Participants in the treatment condition received a brief Barrier Reduction Intervention (BRI) designed to increase the use of crisis service referrals provided on the app. Participants were followed-up several hours later to assess the use of crisis services.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief help-seeking barrier reduction intervention | Behavioral | 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 to help the user overcome the potential barrier(s) they selected. By exploring the menu of barriers, users could read brief messages designed to dispel common misconceptions or 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 or other emergency services. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Use of Crisis-referrals | The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline) | 5 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good" | 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. | 5 hours post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard University | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30883164 | Derived | Jaroszewski AC, Morris RR, Nock MK. Randomized controlled trial of an online machine learning-driven risk assessment and intervention platform for increasing the use of crisis services. J Consult Clin Psychol. 2019 Apr;87(4):370-379. doi: 10.1037/ccp0000389. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control Condition: Users in the control condition experienced the Koko digital platform as usual. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
|
| |||||||||||||||||||||
| Allocation |
| ||||||||||||||||||||||
| Follow up |
| ||||||||||||||||||||||
| Analysis |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control Condition: Users in the control condition experienced the Koko digital platform as usual. |
| BG001 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant age was not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Use of Crisis-referrals | The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline) | Posted | Count of Participants | Participants | 5 hours post intervention |
|
31 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control Condition: Users in the control condition experienced the Koko digital platform as usual. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Harvard University | 617-496-4484 | jaroszewski@fas.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2017 | Aug 14, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2018 | Aug 14, 2018 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| D003863 | Depression |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
Age was not collected.
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Participant sex was not collected. | Sex was not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Participant region of enrollment was not collected. | Region of Enrollment was not collected. | Number | participants |
|
|
|
|
| Secondary | Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good" | 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. | Posted | Count of Participants | Participants | 5 hours post intervention |
|
|
|
|
| 0 |
| 805 |
| 0 |
| 805 |
| 0 |
| 805 |
| EG001 | 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 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. | 0 | 775 | 0 | 775 | 0 | 775 |
Not provided
Not provided