Common Elements Treatment Approach for Excessive Alcohol Consumption

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins Center for American Indian Health Whiteriver Office, Whiteriver, AZExcessive Alcohol Consumption+1 MoreCommon Elements Treatment Approach - Behavioral
Eligibility
25 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a common elements intervention delivered by community mental health workers to see if it is effective, feasible, and acceptable for Apache adults who have experienced adverse childhood experiences.

Eligible Conditions
  • Suicide, Trauma
  • Excessive Alcohol Consumption

Treatment Effectiveness

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: 1 week after training, after piloting intervention (approximately 6 months after training), and 9 months after training

Month 9
Community mental health specialist competency of intervention delivery
Post-Training Knowledge Tests for Supervisors & Community mental Health Specialists
Baseline
Adverse Childhood Experience (ACE) Scale
Week 24
Domestic Violence
Emotional Abuse
Suicidal behavior and risk
Week 24
Alcohol or Other Drugs use
Anxiety
Change in Post Traumatic Stress Symptoms
Communal Mastery
Coping
Functioning
Grief
Historical Loss Scale
Hope
Identity
International Depression Symptom Scale (IDSS)
Self-Esteem
Feeling suicidal (finding)
Week 12
Mental Health and Wellbeing

Trial Safety

Trial Design

3 Treatment Groups

Case management
1 of 3
Wait-list
1 of 3
Sessions with a community mental health specialist
1 of 3

Active Control

Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Common Elements Treatment Approach · No Placebo Group · N/A

Sessions with a community mental health specialist
Behavioral
Experimental Group · 1 Intervention: Common Elements Treatment Approach · Intervention Types: Behavioral
Case management
Behavioral
ActiveComparator Group · 1 Intervention: Common Elements Treatment Approach · Intervention Types: Behavioral
Wait-list
Behavioral
ActiveComparator Group · 1 Intervention: Common Elements Treatment Approach · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Common Elements Treatment Approach
2012
N/A
~870

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week after training, after piloting intervention (approximately 6 months after training), and 9 months after training

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
372 Previous Clinical Trials
1,946,512 Total Patients Enrolled
Mary Cwik, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
4 Previous Clinical Trials
748 Total Patients Enrolled
Emily Haroz, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
2 Previous Clinical Trials
210 Total Patients Enrolled

Eligibility Criteria

Age 25 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have thought about suicide or attempted it, hurt yourself on purpose, or excessively consumed drugs or alcohol in the last three months as confirmed by the Apache suicide surveillance system.
You have had at least two negative experiences during your childhood.
You are a member of a Native American community.
You have symptoms of posttraumatic stress that are moderate or severe.

Frequently Asked Questions

Can individuals under 45 years of age join the experiment?

"Prospective participants must be between 25 and 65 years old to qualify for this trial. Those younger than 18 will find 254 trials on offer, while those older than 65 have access to 957 clinical studies." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this clinical experiment?

"According to the clinicaltrials.gov webpage, this clinical trial is actively seeking enrolment with an initial posting date of July 19th 2022 and most recent update on August 9th 2022." - Anonymous Online Contributor

Unverified Answer

May I join the experiment for this clinical trial?

"The desired cohort for this clinical study consists of 100 adults aged 25-65 with a history of suicide ideation, self-injurious behaviour or substance abuse over the past 90 days. In addition to these criteria, candidates must have experienced at least two adverse childhood experiences and live on or near the Fort Apache Indian Reservation as well as having an average score of 1 or more on a posttraumatic stress measure." - Anonymous Online Contributor

Unverified Answer

What is the size of the cohort contributing to this medical experiment?

"Yes, the study is actively recruiting. The trial was first posted on July 19th 2022 and it has since been revised once, as of August 9th. They are looking to enrol 100 patients from a single clinical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.