NCT03755206

Brief 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. The aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.9 years

First QC Date

November 20, 2018

Results QC Date

August 4, 2024

Last Update Submit

September 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

Intervention

OTHER

Interrupted time series design

Other: Sustainability strategies

Interventions

The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online Survey

Whiteriver, Arizona, 85941, United States

Location

Results Point of Contact

Title
Dr. Emily E. Haroz, Associate Professor
Organization
Johns Hopkins Center for Indigenous Health

Study Officials

  • Emily E. Haroz, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 27, 2018

Study Start

December 10, 2018

Primary Completion

October 31, 2023

Study Completion

April 24, 2024

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations