- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03755206
Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings (Sust-AIns)
September 13, 2024 updated by: Johns Hopkins Bloomberg School of Public Health
The proposed study is part of the research project for a National Institute of Mental Health K01 grant to Dr. Haroz.
The overall research project is focused on understanding how to sustain evidenced-based mental and behavioral health programs in tribal contexts.
The aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Among the most pressing issues in mental health Dissemination and Implementation research (D&I) is the lack of knowledge about how to sustain mental health prevention and treatment services for which there is substantial evidence of impact.
Most D&I studies focus on adoption and initial implementation, with few studies (<20) rigorously exploring sustainment.
The sustainment of services has been described as "one of the greatest, yet least understood, challenges in the field of implementation science."
The gap in knowledge is even greater for low-resource contexts, as few studies have focused on these settings.
This project aims to address this gap by developing and testing sustainment strategies for an evidenced-based youth suicide prevention program in a low-resource, American Indian (AI) contexts.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Whiteriver, Arizona, United States, 85941
- Online Survey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Knowledgeable about the implementation of the suicide prevention program
- Over the age of 18
- Available to participate in required study meetings and assessments
- Fluent in English
Exclusion Criteria:
- Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Interrupted time series design
|
The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Sustainability Assessment Tool
Time Frame: 1 year
|
Tool that assess domains of capacity for sustainability.
Possible score range 0-3, higher scores indicate more capacity for program sustainability.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Emily E. Haroz, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2018
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
April 24, 2024
Study Registration Dates
First Submitted
November 20, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 27, 2018
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 13, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00008138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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