Brief Interventions for the Prevention of Suicide and the Promotion of Resilience
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ClinicalTrials.gov Identifier: NCT03132766 |
Recruitment Status :
Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
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Condition or disease | Intervention/treatment | Phase |
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Suicide | Behavioral: Case Management Behavioral: New Hope Curriculum Behavioral: Elders' Resilience Curriculum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | SMART Design |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | New Hope and the Elders' Resilience Interventions for the Prevention of Suicide and Promotion of Resilience in Suicidal American Indian Youth |
Estimated Study Start Date : | January 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: New Hope + Elders' Resilience + CM
Participants will receive case management plus the New Hope curriculum and subsequently the Elders' Resilience curriculum.
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Behavioral: Case Management
Community Mental Health Workers (CMHW), who are trained surveillance system staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the SIQ to assess imminent risk, and referral to a local mental health center. Case managers will also facilitate connections to other care providers (traditional healers, church, Indian Health Service (IHS) social services/mental health, and private providers). Behavioral: New Hope Curriculum New Hope (NH) is psychoeducation to supplement and promote mental health services, while encouraging connections to traditional healers and caring adults. The intervention is designed to be implemented over 1 visit (2-4 hours) in a youth-preferred setting. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by WMAT-CAIH with Native actors, vignettes specific to this community, and Elders speaking in their tribal language (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life. Youth are encouraged to choose a support person from his/her family to take part in the intervention. Behavioral: Elders' Resilience Curriculum Elders' Resiliency (ER) intervention. Apache traditions confer behavioral repertoires and values taught through storytelling, observation, and parenting at the family and community level that have carried the Apache people through generations of adversity and historical trauma. ER is a brief (2-4 hours) distillation of these concepts intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength. |
Experimental: New Hope + CM
Participants will receive case management plus the New Hope curriculum.
|
Behavioral: Case Management
Community Mental Health Workers (CMHW), who are trained surveillance system staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the SIQ to assess imminent risk, and referral to a local mental health center. Case managers will also facilitate connections to other care providers (traditional healers, church, Indian Health Service (IHS) social services/mental health, and private providers). Behavioral: New Hope Curriculum New Hope (NH) is psychoeducation to supplement and promote mental health services, while encouraging connections to traditional healers and caring adults. The intervention is designed to be implemented over 1 visit (2-4 hours) in a youth-preferred setting. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by WMAT-CAIH with Native actors, vignettes specific to this community, and Elders speaking in their tribal language (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life. Youth are encouraged to choose a support person from his/her family to take part in the intervention. |
Experimental: Elders' Resilience + CM
Participants will receive case management plus the Elders' Resilience curriculum.
|
Behavioral: Case Management
Community Mental Health Workers (CMHW), who are trained surveillance system staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the SIQ to assess imminent risk, and referral to a local mental health center. Case managers will also facilitate connections to other care providers (traditional healers, church, Indian Health Service (IHS) social services/mental health, and private providers). Behavioral: Elders' Resilience Curriculum Elders' Resiliency (ER) intervention. Apache traditions confer behavioral repertoires and values taught through storytelling, observation, and parenting at the family and community level that have carried the Apache people through generations of adversity and historical trauma. ER is a brief (2-4 hours) distillation of these concepts intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength. |
Active Comparator: CM alone
Participants will receive case management only.
|
Behavioral: Case Management
Community Mental Health Workers (CMHW), who are trained surveillance system staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the SIQ to assess imminent risk, and referral to a local mental health center. Case managers will also facilitate connections to other care providers (traditional healers, church, Indian Health Service (IHS) social services/mental health, and private providers). |
- Change in Suicide Ideation Questionnaire (SIQ/SIQ-JR) at 6 months [ Time Frame: Baseline to 180 days ]The SIQ is a 15-item scale that analyzes frequency and severity of suicidal ideation over the past 6 months. Items are scored on a 7-point scale ranging from 0 "I never had this thought" to 6 "Almost every day." Scores of 30 for the SIQ and 23 for the SIQ-JR indicate severe suicidal ideation and need for clinical intervention.
- Change in Child and Youth Resilience Measure (CYRM) at 6 months [ Time Frame: Baseline to 180 days ]The CYRM consists of 28 items about socio-ecological aspects of resilience including access to material resources, relationships, identity, power and control, cultural adherence, social justice and cohesion. Items are scored on 5-point scale ranging from 1 "not at all" to 5 "a lot."

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Ages Eligible for Study: | 10 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- American Indian youth ages 10 to 24 years old.
- Parent/guardian consent for youth under 18 years old.
- Suicide ideation, binge substance use or suicide attempt in the past 30 days as identified and verified by the surveillance system.
Exclusion Criteria:
- Factors identified at baseline that preclude full participation, including: unstable and severe medical, psychiatric or drug use problem that necessitates inpatient treatment; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement.
Ambiguous cases will be reviewed by one of the co-PIs before being deemed eligible for recruitment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132766
Contact: Mary F Cwik, PhD | 443-287-5171 | mcwik1@jhu.edu | |
Contact: Allison Barlow, PhD | 410-955-6931 | abarlow@jhu.edu |
Principal Investigator: | Allison Barlow, PhD | Johns Hopkins Bloomberg School of Public Health | |
Principal Investigator: | Mary Cwik, PhD | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT03132766 |
Other Study ID Numbers: |
CAIHHub2017 |
First Posted: | April 28, 2017 Key Record Dates |
Last Update Posted: | April 28, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data may be shared at the discretion of the Tribe(s). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Suicide Self-Injurious Behavior Behavioral Symptoms |