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Completed

NCT Number: NCT04585906

My Pathway to Healing

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for American Indian Health Whiteriver Office

Whiteriver, Arizona, 85941, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Common Elements Treatment Approach

Behavioral

The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping.

Primary outcomes

  1. Number of Participants Completing Visits

    Time frame: Up to 12 weeks post-baseline

    Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility.

  2. Number of People Approached Who Consented or Declined

    Time frame: At consent

    This timepoint is pre-randomization. 68 potential participants were approached to join the study; feasible if those who decline participation is less than 20%, a lower decline percentage indicates greater feasibility. A higher consent percentage indicates greater feasibility.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • Native American Research Center for Health

Registry information

Official study title

My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse

Acronym: MP2H

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2020
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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