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Zero Suicide Plus KICKS

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ClinicalTrials.gov Identifier: NCT03924037
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Brandi Fink, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Suicide Suicidal Ideation Suicidal Intention Suicidal and Self-injurious Behavior Behavioral: Intergenerational Knowledge Sharing group Behavioral: Support group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will utilize a between-subjects design with random assignment to the control (ZS) and the experimental groups (ZS+).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating Intergenerational Cultural Knowledge Exchange With Zero Suicide
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Zero Suicide
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
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.

Experimental: Zero Suicide plus KICKS
Participants randomly assigned to the Zero Suicide plus KICKS arm will participate in a weekly intergenerational knowledge sharing group.
Behavioral: Intergenerational Knowledge Sharing group
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.




Primary Outcome Measures :
  1. Reduction in suicidal behavior [ Time Frame: 12 weeks ]
    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.

  2. Improvement in resilience [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03924037


Contacts
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Contact: Deborah Altschul, PhD 505-272-6238 daltschul@salud.unm.edu
Contact: Brandi C Fink, PhD 505-272-6045 bcfink@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Deborah Altschul, PhD    505-272-6238    daltschul@salud.unm.edu   
Contact: Brandi C Fink, PhD    5052726045    bcfink@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Deborah Altschul, PhD University of New Mexico
Principal Investigator: Brandi C Fink, PhD University of New Mexico

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Responsible Party: Brandi Fink, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03924037     History of Changes
Other Study ID Numbers: 18-031
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms