Brief Interventions for the Prevention of Suicide and the Promotion of Resilience

• ClinicalTrials.gov Identifier: NCT03132766
• Recruitment Status: Not yet recruiting
• First Posted: April 28, 2017
• Last Update Posted: April 28, 2017
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

Study Description

Brief Summary:

This study will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are identified by a surveillance system as having recent suicide ideation or behaviors or binge substance use. This five-year study tests a sequence of novel preventive strategies that American Indian (AI) tribes can use to sustainably reduce the burden of AI youth suicide and promote resilience. The study will evaluate the effectiveness of task-shifting the administration of interventions to culturally embedded paraprofessionals. The Johns Hopkins Center for American Indian Health (CAIH) will provide research oversight and the White Mountain Apache Tribe (WMAT) will be the primary study site. Navajo Nation (NN) will participate as a secondary site in years 4-5. The study investigators hypothesize that: a) New Hope vs. Case Management alone will significantly reduce participant suicidal ideation; b) Elders Resilience vs. Case Management alone will significantly improve participant resilience; c) New Hope followed by Elders Resilience will have the strongest effects on suicidal ideation and resilience; and d) Case Management alone will have the weakest effects of all combinations.

Condition or disease	Intervention/treatment	Phase
Suicide	Behavioral: Case Management; Behavioral: New Hope Curriculum; Behavioral: Elders' Resilience Curriculum	Not Applicable

Study Design

• 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

Arms and Interventions

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.	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).

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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."

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Mary F Cwik, PhD; 443-287-5171; mcwik1@jhu.edu

Contact: Allison Barlow, PhD; 410-955-6931; abarlow@jhu.edu

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Allison Barlow, PhD; Johns Hopkins Bloomberg School of Public Health
• Principal Investigator: Mary Cwik, PhD; Johns Hopkins Bloomberg School of Public Health

More Information

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT03132766
• Other Study ID Numbers: CAIHHub2017
• First Posted: April 28, 2017
• 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

Additional relevant MeSH terms:

Suicide; Self-Injurious Behavior; Behavioral Symptoms