My Pathway to Healing

Binge Drinking Clinical Trial

— MP2H  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04585906
• Other study ID #: JHSPH-9500
• Secondary ID: 1S06GM127981
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this project is to test the effectiveness, 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.

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." Apache partners selected a randomized control trial, as it is a rigorous study design for understanding whether an intervention works, to evaluate the effectiveness of the My Pathway to Healing intervention delivered by community mental health specialists (CMHS). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Drinking
• Suicide
• Suicide; Trauma

Intervention

Behavioral:
• Common Elements Treatment Approach
The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health Whiteriver Office	Whiteriver	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Native American Research Centers for Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post Traumatic Stress Symptoms	Post traumatic stress symptoms will be measured using part 4 of the Harvard Trauma Questionnaire (HTQ). The scale ranges from 0 (Not at All) to 4 (Extremely). A higher score indicates a worse outcome.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	International Depression Symptom Scale (IDSS)	The IDSS will be used to measure depression symptom severity. The scale ranges from 0-3. A higher score indicates a worse outcome.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Anxiety	Investigators will use the Hopkins Symptom Checklist for Anxiety to measure severity of anxiety symptoms. This scale will range from 1-4. A higher score indicates a worse outcome.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Alcohol and Substance Use	Investigators will use the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) to measure alcohol and substance use. This 15-item questionnaire screens for all levels of problems or risky substance use (alcohol, illegal drugs, and prescription drugs). A risk score is provided for each substance, and scores are grouped into low, moderate, or high risk, providing a comprehensive view of substance use. This scale ranges from 0-27+. A total score of 0-3 indicates low risk/no intervention. A total score of 4-26 indicates moderate risk/brief intervention. A total score of 27+ indicates high risk/more intensive treatment.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Suicidal ideation	We are using a 27-item version of The Suicide Ideation Questionnaire (SIQ) which has been previously adapted and tested in the local context. Each item is answered on a 7-point scale that assesses the frequency and severity of suicidal ideation in the past month, with scores from 0-162. Positive screens on the SIQ are defined as scoring at or above the suggested clinical cutoff of 37. The SIQ has previously been used with Native American groups, with a sensitivity and specificity of .80 and .86, and strong internal consistency for the total score (a = 0.96). As described above, the SIQ is administered during the initial follow-up visit as part of our current case management practice. The study team has devised a comprehensive safety protocol, approved by the JHU IRB and the WMAT Tribal Council and Health Board, to triage depending on risk.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Hope	Investigators will use the Trait Hope Scale to measure levels of hopefulness. This scale consists of 8 items and total scores range from 0-96. A higher score indicates a higher perceived level of hope (i.e. positive outcome).	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Communal Mastery	Investigators will use a 10-item communal mastery questionnaire developed from two commonly employed measures of mastery and self-efficacy and adapted to add more collectivist statements for use specifically in Native American populations to measure self-efficacy and knowledge of communal resources. Scores will range from 0-40. A higher score indicates a more positive outcome.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Historical Loss Scale	Investigators will use a 14-item version of the Historical Loss Scale, a self-report measure assessing the frequency with which Indigenous individuals think about loss of land, peoples, culture, ways of life as a result of colonization (i.e., historical trauma) to measure types of historical discrimination and trauma. Responses are scored on a 6-point Likert-type scale from never (1) to several times a day (6); scores are recoded so that higher scores indicate higher frequency of thinking about historical trauma. Just items 1-13 are used in scoring as item 14 is an open ended question.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Adverse Childhood Experience (ACE) Scale	Investigators will use an adapted version of the Behavioral Risk Factor Surveillance System (BRFSS) ACEs module in combination with questions about ACEs identified in formative qualitative work for this project. The ACEs scale ranges from 0-31. A higher score indicates more adverse childhood experiences.	Baseline
Secondary	Self-Esteem	Investigators will use the Rosenberg Self-Esteem Scale to measure level of self-esteem. The 10-item scale ranges from 0-30. A higher score indicates a higher level of self-esteem (i.e., positive outcome).	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Coping	Investigators will use an adapted version of the Brief Cope Measure to assess a participant's ability to cope with stress in their life. The measure includes 28 items and response options range from 1-4. A higher overall score indicates a better outcome.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Functioning	Investigators developed a locally relevant functioning scale from primary outcome data, in which participants were asked about tasks and activities that are important for people to do for themselves, their families and the community. The most frequently mentioned responses are combined to create the 9-item scale. The scale ranges from 0-4. A higher score indicates a worse outcome. This approach has been used widely in culturally diverse contexts internationally. We also include the 12 items from the World Health Organization's Disability Assessment Schedule (WHODAS) 2.0 which assess activities of daily living combined with two items from formative work. Each item of the WHODAS 2.0 is scored on 0 to 4 scale, with total possible scores ranging from 0-56 and higher meaning more difficulty in functioning.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Mental Health and Wellbeing	The Client Monitoring Form will be used to track the mental health and well-being of intervention participants on a regular basis. There are 17-questions that measure recent substance use, anxiety and depression symptoms, and PTSD symptoms. Questions are asked on a scale of 0 (never) to 4 (Daily or almost daily). A higher score indicates a worse outcome. Additionally, clients are screened for suicidal ideation.	Regularly from baseline to 8-12 weeks post baseline (during intervention sessions)
Secondary	Grief	The brief grief questionnaire will be used to assess symptoms of grief. This 5-item scaled has been adapted for this study to ask about deaths of loved ones, instead of the death of a single index loved one. Each question is scored from 1-3, with a total sum calculated and higher scores indicating a greater burden of grief.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)
Secondary	Identity	A modified version of the Leach identification scale adapted for the local context is used to assess tribal identity and how much an individual identifies with and feels connected to their community. Response options range from 0-3 on this 7-item scale.	Baseline, Endline (8-12 weeks after baseline), Follow Up 1 (16 weeks after baseline), Follow Up 2 (20 weeks after baseline) Follow Up 3 (24 weeks after baseline)