Suicidal IdeationCARENCT02825771
Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
A study testing Caring Contacts Messages in people with Suicidal Ideation and Suicide, Attempted, run by Washington State University at 1 site in United States.
Trial summary
Suicide is the second leading cause of death for American Indians and Alaska Natives aged 18 years and older. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring messages to people at risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Caring Contacts Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be suicidal (Suicidal Ideation Questionnaire clinical cut-off score ≥ 32) or have a documented or self-reported suicide attempt within the past year
- be 18 years or older
- self-identify as American Indian or Alaska Native
- are willing to be contacted periodically via text, email, or postal mail
- able to participate voluntarily
- speak and read English
Who cannot join
- 1) Cognitively unable and willing to independently provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99202
About this study
Suicide is the second leading cause of death for American Indians and Alaska Natives aged 18 years and older. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring messages to people at risk. The investigators will implement the intervention at four tribal sites, leveraging community strengths and values to address this tragic health disparity in an underserved minority population.
Read the detailed description
High rates of suicide are endemic in American Indian and Alaska Native (AI/AN) young adults. A recent study found that rates for young AI/AN adults in the Northern Plains and in Alaska are more than 4 times higher than for Whites of the same age in the same regions. Building social connections is a key goal of suicide prevention. One validated theoretical model asserts that belonging to a group is a fundamental human need. When this need is thwarted by social isolation or inadequate social support, a desire for death emerges. Studies of suicide prevention in AI/ANs underscore the cultural importance of connection to friends, family, caring neighbors, and community leaders. These traditions of community cohesion can be leveraged to protect young AI/AN adults against suicidal ideation and behavior. Caring Contacts is a suicide prevention program that supplements standard care by promoting human connectedness. People at risk for suicide often lose contact with the healthcare system and receive no follow-up care. For one year after initial contact, Caring Contacts seeks out such individuals to send messages expressing care, concern, and interest. It is the only intervention shown to prevent suicide in any population in a randomized, controlled trial. Based on a two year collaborative process with four tribal partners as part of a pilot grant, this study will evaluate a locally feasible, culturally appropriate Caring Contacts intervention that will use text messaging, email, and postal mail. This study uses a randomized, controlled trial (RCT) to evaluate this approach to suicide prevention in 1,200 high-risk AI/ANs aged 18 and older from our four partner communities. Specific Aims are to: 1) Compare the effectiveness of usual care (control) to the control condition plus caring text messages (intervention) for reducing suicidal ideation, suicide attempts, and suicide related hospitalizations. 2) Evaluate social connectedness as a mediating factor for the effect of Caring Contacts via text message on suicidality. The US Surgeon General's National Strategy for Suicide Prevention identifies connectedness to others as a primary protective factor against suicidality. By adapting and disseminating the Caring Contacts approach, which has demonstrated effectiveness in non-Native populations, this study will evaluate a low-cost, sustainable intervention for addressing the profound disparity of suicide risk experienced by young adult AI/ANs.
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Being tested
- Caring Contacts Messages, Usual Care
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring Contacts MessagesBehavioural
Text messages expressing care and support are sent following initial meeting on the following schedule: next day, 6 weekly, 9 bi-weekly, 7 monthly; one each on birthday, holiday, and seasonal (total of 25)
Usual CareBehavioural
Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health
| Study group | Role | What they receive |
|---|---|---|
| Usual Care + Caring Contacts messages | Experimental | Usual care services plus caring contacts messages Receives: Behavioral: Caring Contacts Messages; Behavioral: Usual Care |
| Usual Care | Active comparator | Usual care services provided in that community following identification of suicidal ideation or behavior. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation Questionnaire (SIQ)
The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month
Measured: 12 and 18 months
Suicide Attempt and Self-Injury Count (SASI-Count)
The SASI-Count interview assesses the method, intent, treatment received, and lethality for all suicide attempts in the follow-up time frame
Measured: 12 and 18 months
Suicide-related hospitalizations
Hospitalizations will be assessed using the American Indian Services Utilization and Psychiatric Epidemiology Risk and Protective Factors Project (AI-SUPERPFP) measure of service utilization which captures all admissions to inpatient medical and psychiatric care as well as emergency room visits
Measured: 12 and 18 months
Secondary outcomes (1)
Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale
Thwarted belongingness is one of two subscales on the INQ that measures the lack of perceived social connectedness
Measured: 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start30 May 2018
- Primary completion31 Oct 2023
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lonnie Nelson, Washington State University
- Investigators
- Lonnie A Nelson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825771
- Sponsor's protocol ID
- UWashington
- Other IDs
- 1R01MH106419-01A1
- Acronym
- CARE
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2016
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Collaborative decision with four tribal partners.
Publications
Hebert LE, Fruhbauerova M, Evanson A, Bogic M, Petras A, Shaw J, Muller CJ, Nelson L, Comtois KA. Caring Texts, a strength-based, suicide prevention trial in 5 native communities: Research design and methods. Contemp Clin Trials. 2022 Dec;123:106966. doi: 10.1016/j.cct.2022.106966. Epub 2022 Oct 14.
PubMed 36252937
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Contacts: A Strength-based, Suicide Prevention Trial in 4 Native Communities
- ClinicalTrials.gov ID
- NCT02825771
- Acronym / sponsor ID
- CARE / UWashington
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suicide is the second leading cause of death for American Indians and Alaska Natives aged 18 years and older. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring messages to people at risk. The investigators will implement the intervention at four tribal sites, leveraging community strengths and values to address this tragic health disparity in an underserved minority population.
Detailed description
High rates of suicide are endemic in American Indian and Alaska Native (AI/AN) young adults. A recent study found that rates for young AI/AN adults in the Northern Plains and in Alaska are more than 4 times higher than for Whites of the same age in the same regions. Building social connections is a key goal of suicide prevention. One validated theoretical model asserts that belonging to a group is a fundamental human need. When this need is thwarted by social isolation or inadequate social support, a desire for death emerges. Studies of suicide prevention in AI/ANs underscore the cultural importance of connection to friends, family, caring neighbors, and community leaders. These traditions of community cohesion can be leveraged to protect young AI/AN adults against suicidal ideation and behavior. Caring Contacts is a suicide prevention program that supplements standard care by promoting human connectedness. People at risk for suicide often lose contact with the healthcare system and receive no follow-up care. For one year after initial contact, Caring Contacts seeks out such individuals to send messages expressing care, concern, and interest. It is the only intervention shown to prevent suicide in any population in a randomized, controlled trial. Based on a two year collaborative process with four tribal partners as part of a pilot grant, this study will evaluate a locally feasible, culturally appropriate Caring Contacts intervention that will use text messaging, email, and postal mail. This study uses a randomized, controlled trial (RCT) to evaluate this approach to suicide prevention in 1,200 high-risk AI/ANs aged 18 and older from our four partner communities. Specific Aims are to: 1) Compare the effectiveness of usual care (control) to the control condition plus caring text messages (intervention) for reducing suicidal ideation, suicide attempts, and suicide related hospitalizations. 2) Evaluate social connectedness as a mediating factor for the effect of Caring Contacts via text message on suicidality. The US Surgeon General's National Strategy for Suicide Prevention identifies connectedness to others as a primary protective factor against suicidality. By adapting and disseminating the Caring Contacts approach, which has demonstrated effectiveness in non-Native populations, this study will evaluate a low-cost, sustainable intervention for addressing the profound disparity of suicide risk experienced by young adult AI/ANs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care + Caring Contacts messages | Experimental | Behavioral: Caring Contacts Messages, Behavioral: Usual CareUsual care services plus caring contacts messages |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care services provided in that community following identification of suicidal ideation or behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be suicidal (Suicidal Ideation Questionnaire clinical cut-off score ≥ 32) or have a documented or self-reported suicide attempt within the past year
- be 18 years or older
- self-identify as American Indian or Alaska Native
- are willing to be contacted periodically via text, email, or postal mail
- able to participate voluntarily
Key exclusion criteria (1 listed)
- 1) Cognitively unable and willing to independently provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caring Contacts MessagesText messages expressing care and support are sent following initial meeting on the following schedule: next day, 6 weekly, 9 bi-weekly, 7 monthly; one each on birthday, holiday, and seasonal (total of 25) | Behavioural | Usual Care + Caring Contacts messages |
| Usual CareUsual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health | Behavioural | Usual Care, Usual Care + Caring Contacts messages |
Primary outcome
Suicidal Ideation Questionnaire (SIQ)
Time frame: 12 and 18 months
The SIQ comprises 15 items assessing frequency of suicidal thoughts in the past month
Suicide Attempt and Self-Injury Count (SASI-Count)
Time frame: 12 and 18 months
The SASI-Count interview assesses the method, intent, treatment received, and lethality for all suicide attempts in the follow-up time frame
Suicide-related hospitalizations
Time frame: 12 and 18 months
Hospitalizations will be assessed using the American Indian Services Utilization and Psychiatric Epidemiology Risk and Protective Factors Project (AI-SUPERPFP) measure of service utilization which captures all admissions to inpatient medical and psychiatric care as well as emergency room visits
1 secondary outcome
Interpersonal Needs Questionnaire (INQ) Thwarted Belongingness subscale
Time frame: 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 36252937Hebert LE, Fruhbauerova M, Evanson A, Bogic M, Petras A, Shaw J, Muller CJ, Nelson L, Comtois KA. Caring Texts, a strength-based, suicide prevention trial in 5 native communities: Research design and methods. Contemp Clin Trials. 2022 Dec;123:106966. doi: 10.1016/j.cct.2022.106966. Epub 2022 Oct 14.
- Individual participant dataSharing planned: No. Collaborative decision with four tribal partners.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lonnie A Nelson, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Contacts Messages in people with Suicidal Ideation and Suicide, Attempted, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Ideation Questionnaire (SIQ) (time frame: 12 and 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.