NCT04604574

Brief Summary

Background: The negative health outcomes experienced by Indigenous peoples may be understood as direct consequences of colonization. One of the key consequences of the colonial influence on Canada's Indigenous peoples has been intergenerational trauma (IGT). Indigenous communities in Canada face significant challenges with IGT, which often manifest in substance use disorders (SUD). Indigenous communities have identified SUD as one of their greatest health challenges(Maté 2009), with some Northern Ontario First Nations communities experiencing SUD rates of 70% (Calveson 2010). Most Elders, traditional healers, and Indigenous scholars agree that connecting treatment to culture, land, community, and spiritual practices is a pathway to healing trauma and SUD for Indigenous peoples. Recent work by Dr. Teresa Naseba Marsh has demonstrated that Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy can be effectively combined for the treatment of Indigenous patients with a history of trauma and SUD. Seeking Safety incorporates the inclusion of the mind, body, spirit, and self-awareness during treatment, and the perspective of Seeking Safety is convergent with traditional Indigenous healing methods. Benbowopka Treatment Centre is a residential treatment site operated by Mamaweswen, located in the North Shore Tribal Council in Blind River, Ontario. Benbowopka's mandate is to provide treatment for Indigenous clients with trauma and SUD. They are also implementing a culturally sensitive program grounded in IHSS methodology for the treatment of Indigenous patients' trauma and SUD. Through our current collaboration with Benbowopka and Mamaweswen the applicants have collected baseline data from client files to establish historical outcomes going back three years. In 2016, we began the collaborative implementation of the Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy for clients at Benbowopka. Objective: The purpose of this proposal is to evaluate the effectiveness of the IHSS intervention which blends Indigenous Healing Practices and a mainstream treatment model, Seeking Safety for the treatment of Indigenous patients with a history of trauma and SUD. Methodology: In collaboration with the North Shore Tribal Council and the Benbowopka Treatment Center, we propose a prospective evaluation of IHSS treatment for Indigenous patients with a history of trauma and SUD. Benbowopka treats approximately 90 patients per year in a residential treatment program, and the program has high quality retrospective data on their programming and outcomes. We propose to benchmark anonymized historical program outcomes by evaluating program outcomes and the impact of program completion on health systems usage. Impact of treatment on health system usage will be determined by linking anonymized patient records with records at the Institute for Clinical and Evaluative Sciences (ICES). ICES linkage will provide further insight into hospitalizations, interaction with emergency, mental health, and primary care usage before and following the implementation of the IHSS intervention. We will respect the Tricouncil Policy Statement, Chapter 9, which highlights the importance of engaging with First Nations throughout all phases of the research process. In addition, we will honour Indigenous knowledge by engaging with Elders and the North Shore Tribal council. Through the data governance protocols established at ICES, we will respect the First Nations principles of ownership, control, access and possession of data (OCAP™). Dr. Jennifer Walker Canada Research Chair in Indigenous Health at the Center for Rural and Northern Health Research and ICES Scientist will oversee the process of data sharing and linking de-identified Benbowopka treatment data to anonymized health system data at ICES. Benbowopka and the North Shore Tribal council will maintain complete ownership over the study data and its subsequent dissemination. Anticipated Outcome: We expect that patients who are treated in the IHSS treatment model will have improved outcomes as compared to previous patients of Benbowopka treated under the abstinence based model of therapy. Objectives measures will include treatment completion, substance use at program completion, substance use at follow-up, ED visits, hospitalization, and death. Patient satisfaction will be tracked using surveys administered at treatment completion and is expected to improve with implementation of IHSS. Impact: We expect to demonstrate that the IHSS is a culturally sensitive and effective treatment model for Indigenous patients who are affected by trauma and substance use disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration 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

Study Start

First participant enrolled

January 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

October 13, 2020

Last Update Submit

October 21, 2020

Conditions

Keywords

Indigenous HealthSeeking SafetyHealth Care UtilizationResidential Addiction Treatment

Outcome Measures

Primary Outcomes (3)

  • the patient perspective

    we will use Client Quality Assurance Survey tool to assess the appropriateness and satisfaction of the intervention.

    28 days

  • the program perspective

    we will use the structured assessments at admission to characterize changes in the patient population and the program completion rate as primary outcome to assess the effectiveness of the IHSS intervention

    28 days

  • the community perspective

    Change in substance use related health system usage (number of Emergency room presentation and number of acute care admissions for substance use related conditions) between the year prior and the year following treatment completion as an indication of the impact of the admission on health system outcomes.

    One Year

Study Arms (1)

Pre/Post-Intervention

OTHER

Patients who receive the novel IHSS intervention will be compared to historical controls who received the abstinence-based treatment model.

Other: Indigenous Healing and Seeking Safety

Interventions

Indigenous Healing and Seeking Safety Intervention: Initial 90-minute meetings will be conducted with the participants; during these meetings, participants will receive information about IHSS, traditional healing, sharing circles, sweat lodge ceremonies, and program details. The sharing circles will take place at Benbowopka Residential treatment Centre in Blind River, Ontario. Each of the sharing circles will be cofacilitated by two Indigenous health-care workers. These facilitators will organize and lead sharing circles daily throughout the 28-day treatment cycle. Each sharing circle will be two hours long. The Seeking Safety program consists of up to 25 treatment topics that aim to teach participants a variety of skills. The majority of topics address the cognitive, behavioral, interpersonal, and case management needs of persons with SUD and posttraumatic stress disorders (PTSD) (Najavits, 2002a). The treatment will adhere to the concept of Two-Eyed Seeing and cultural sensitivity.

Also known as: Abstinence-Based Treatment Historical Control
Pre/Post-Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Substance Use Disorder
  • Intergenerational Trauma

You may not qualify if:

  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Ontario School of Medicine

Greater Sudbury, Ontario, P3E2C6, Canada

Location

Related Publications (1)

  • Morin KA, Marsh TN, Eshakakogan C, Eibl JK, Spence M, Gauthier G, Walker JD, Sayers D, Ozawanimke A, Bissaillion B, Marsh DC. Community trial evaluating the integration of Indigenous healing practices and a harm reduction approach with principles of seeking safety in an Indigenous residential treatment program in northern Ontario. BMC Health Serv Res. 2022 Aug 16;22(1):1045. doi: 10.1186/s12913-022-08406-3.

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-TraumaticHistorical TraumaPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersPsychological TraumaTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • David C Marsh, MD

    Northern Ontario School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: We plan to conduct a pre/post intervention matched comparison group study. We will compare historical treatment outcomes for past Benbowopka patients to outcomes following IHSS treatment for Indigenous patients with a history of trauma and SUD. All patient data will be anonymized at the time of data entry. Propensity matching will be undertaken for patient characteristics, including sex/gender, age, and substance use type. The National Native Alcohol and Drug Abuse Program (NNADAP) tool will be used to analyze the program objective; that is, whether completion rates improve following the implementation of the IHSS intervention. Additionally, a Client Quality Assurance Survey (attached) will be utilized to determine patient satisfaction.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 27, 2020

Study Start

January 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations