RECRUITING

Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence. This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA).

Official Title

Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship

Quick Facts

Study Start:2024-03-01
Study Completion:2029-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05786157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Any gender identity; any race or ethnicity; ages 21 years or older.
  2. 2. Must report ≥ 2 heavy drinking episodes in the past 30 days (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) and consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory (assessed via the TimeLine Follow Back,TLFB).
  3. 3. At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the Conflict Tactics Scale, CTS-2).
  4. 4. Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.
  5. 5. One or both partners in half the couples will be required to meet diagnostic criteria for PTSD (assessed by the Clinical Administered Posttraumatic Stress Scale, CAPS-5).
  1. 1. Possible alcohol or drug use disorder (except caffeine or nicotine) as defined by the Alcohol Use Disorders Identification Test, AUDIT scores \>8 or Drug Abuse Screening Test DAST scores \>3; meeting Diagnostic and Statistical Manual of Mental Disorders, DSM-5 diagnostic criteria; or having ever sought treatment for alcohol or drug use disorder. Recent recreational drug use (e.g., cannabis) is acceptable.
  2. 2. Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
  3. 3. Current suicidal or homicidal ideation and intent.
  4. 4. History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.
  5. 5. Body weight \> 250 lbs (in order to rigorously control alcohol dosing).
  6. 6. Use of medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic drugs likely to confound normative cardiovascular responding for the psychophysiological component of the project.
  7. 7. Pregnancy or breastfeeding.
  8. 8. Severe or unilateral partner violence in the past 6 months as measured by the CTS-2

Contacts and Locations

Study Contact

Stacey Sellers
CONTACT
843-792-5807
sellersst@musc.edu
Julianne Flanagan
CONTACT
hellmuth@musc.edu

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2029-10-01

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2029-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Posttraumatic Stress Disorder
  • Couples