Zero Suicide Plus KICKS

NCT03924037 | Completed DMC

• 1 other identifier: 18-031
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

Integrating Intergenerational Cultural Knowledge Exchange with Zero Suicide is an innovative study in a Southwestern tribal nation that incorporates Zero Suicide into Indian Health Services (IHS) primary care settings. The goal of this study is to determine the effectiveness of Zero Suicide plus a cultural component (ZS+) (experimental group) compared to Zero Suicide (ZS) alone (control group) on suicidal ideation, behaviors, and resiliency in a randomized control trial of 138 AI youth ages 12-24 at two rural IHS clinics on the Pueblo of San Felipe. The long-term goal of this study is to determine which is more effective at reducing suicidal ideation and behaviors and increasing resiliency, ZS+ or ZS alone. Year 1 will focus on training providers on the Zero Suicide model and manualizing the Katishtya Intergenerational Culture Knowledge Seminars (KICKS) curriculum that was piloted and positively evaluated over the past three summers as a cultural module to improve the adoption and acceptability of Zero Suicide. Years 2-4 will focus on participant recruitment, assignment to experimental and control groups, and implementation. Year 5 will focus on data analysis and dissemination. Data will be collected from all experimental and control group participants at 4 time points: baseline, 12-weeks, 6-months and 9-months to explore the effects of the intervention over time. The central hypothesis is that ZS+ will be more effective then ZS alone. The investigators propose three aims: (1) Specific Aim 1: Using Community Based Participatory Research (CBPR), partner with tribal stakeholders and researchers to formally manualize the KICKS cultural module for Zero Suicide (ZS+); (2) Specific Aim 2: To determine if adding a cultural component to the Zero Suicide model is more effective at reducing risk factors and increasing resiliency in AI youth than Zero Suicide alone; and (3) Specific Aim 3: Determine the essential features of the KICKS module for adaptation by other tribes and disseminate the model.

Conditions

Suicide; Suicidal Ideation; Suicidal Intention; Suicidal and Self-injurious Behavior

Outcome Measures

Primary Outcomes (2)

• Reduction in suicidal behavior

  The individual treatment sessions will result result in a change in suicidal behavior as measured by the Suicidal Behaviors Questionnaire - Revised and the Suicide Ideation Questionnaire at baseline to the completion of individual treatment sessions.

  12 weeks

• Improvement in resilience

  The Intergenerational Knowledge Sharing group should result in a change in youth resilience as measured by the Suicide Resilience Inventory-25 at baseline to the completion of the KICKS group sessions.

  12 weeks

Study Arms (2)

Zero Suicide

ACTIVE COMPARATOR

Participants randomly assigned to the Zero Suicide arm will also participate in a weekly support group until the final follow-up time point when they will be crossed-over into the intergenerational knowledge sharing group.

Behavioral: Support group

Zero Suicide plus KICKS

EXPERIMENTAL

Participants randomly assigned to the Zero Suicide plus KICKS arm will participate in a weekly intergenerational knowledge sharing group.

Behavioral: Intergenerational Knowledge Sharing group

Interventions

Intergenerational Knowledge Sharing group BEHAVIORAL

Participants will attend a CBPR developed 12-session individual treatment for suicidal behavior. In addition to receiving the 12-session individual treatment, participants that are assigned to the Intergenerational Knowledge Sharing group will attend 12 weekly groups taught by tribal elders that focuses on sharing knowledge about the tribe.

Zero Suicide plus KICKS

Support group BEHAVIORAL

Participants will attend a CBPR developed 12-session individual treatment for suicidal behavior. In addition to receiving the 12-session individual treatment, participants that are assigned to the support group will attend 12 weekly support groups led by a behavioral health specialist that focuses on social support of the youth.

Zero Suicide

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Indian youth aged 13-24 years old who are San Felipe tribal members living in the Pueblo
• Endorse suicidal ideation or behaviors on a universal screen by their primary care provider.

You may not qualify if:

• Younger than age of 13 years old or
• Older than the age of 24,
• Not American Indian,
• Youth who do not receive health services at either of the IHS clinics at the Pueblo of San Felipe,
• Youth who screen negative for suicidal ideation and/or behavior,
• Refuse to participate in the study, and/or
• Cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the baseline interview.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Self-Injurious Behavior

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Deborah Altschul, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Brandi C Fink, PhD

  Oklahoma University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will utilize a between-subjects design with random assignment to the control (ZS) and the experimental groups (ZS+).

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 23, 2019
• Study Start: April 27, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)