Clinical trial NCT04585906: My Pathway to Healing
Official title: My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide; Trauma
Binge Drinking
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Native American Research Center for Health
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will use a randomized control design.
Primary purpose: TREATMENT

Brief summary: The goal of this project is to test the feasibility and acceptability of a common elements intervention delivered by community mental health workers for adults with a history of adverse childhood experiences. "Common elements" interventions build cognitive, emotional, interpersonal, and behavioral skills to help address trauma-related distress and build resilience. This will be accomplished using a randomized control trial with Apache adults ages 25-65 with recent suicidal behaviors, self-injurious behaviors, and/or binge substance use.

Detailed description: This is a mixed-methods study with qualitative data informing adaptation and evaluation of a common elements intervention delivered by community mental health specialists, named "My Pathway to Healing." The study includes a pilot trial and CAB discussions to inform our understanding of the feasibility of scaling up the intervention.

The investigators randomized some participants to receive the interventions and some to receive control case manager visits, to pilot what a future effectiveness RCT might be. This intervention integrates psychoeducation, relaxation techniques, problem solving and cognitive coping, and addresses safety (when identified as a problem area). The intervention used in the intervention arm of our study has been developed for the specific context and culture of White Mountain Apache.

Those randomized into the My Pathway to Healing group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over 8-12 weeks. The exact number of sessions will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Those randomized into the control will continue to receive the standard case management via the Apache surveillance system. These control participants will be offered the My Pathway to Healing Program upon completion of the study.

Participants will be asked to partake in 5 study assessments. For intervention participants these assessments will take place at: baseline, after their last intervention session (endline; approximately 8-12 weeks post-baseline) and 4, 8, and 12 weeks post-endline. For control participants, these assessments will take place at: baseline, 8-12 weeks post-baseline (the maximum time the intervention would last; will be referred to as an endline) and 4, 8 and 12 weeks post-endline. These assessment visits will be conducted by Research Program Assistants. Assessments will take approximately 45-90 minutes to complete. In the feasibility study, assessments are not being statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Adults aged 25-65
* Suicide ideation, suicide attempt, self-injurious behavior, and/or binge alcohol and/or drug use within past 90 days confirmed by the Apache suicide surveillance system
* Experienced at least 2 adverse childhood experiences
* Native American
* Reside on or near the Fort Apache Indian Reservation.
* An average score of 1 or above on a measure of symptoms of posttraumatic stress

Exclusion Criteria:

* Unable to provide informed consent
* Have a serious developmental disorder
* Have active psychosis

Primary outcomes:
measure: Number of Participants Completing Visits
timeFrame: Up to 12 weeks post-baseline
measure: Number of People Approached Who Consented or Declined
timeFrame: At consent
Secondary outcomes:
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health Whiteriver Office
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Emily Haroz, PhD
role: PRINCIPAL_INVESTIGATOR
References: