Program SustainabilitySust-AInsNCT03755206
Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings
A study testing Sustainability strategies in people with Program Sustainability, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Program Sustainability
- What is being tested?
- Sustainability strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Program Sustainability
- Being tested
- Sustainability strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainability strategiesOther
The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Interrupted time series design Receives: Other: Sustainability strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Sustainability Assessment Tool
Tool that assess domains of capacity for sustainability. Possible score range 0-3, higher scores indicate more capacity for program sustainability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start10 Dec 2018
- Primary completion31 Oct 2023
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Program SustainabilityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Emily E. Haroz, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755206
- Sponsor's protocol ID
- IRB00008138
- Acronym
- Sust-AIns
- Status last verified
- Sep 2024
- First submitted
- 20 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings
- ClinicalTrials.gov ID
- NCT03755206
- Acronym / sponsor ID
- Sust-AIns / IRB00008138
- Conditions
- Program Sustainability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Sustainability strategiesInterrupted time series design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustainability strategiesThe investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program. | Other | Intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily E. Haroz, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainability strategies in people with Program Sustainability, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Sustainability Assessment Tool (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.