RECRUITING

Feasibility of the 5-Step Method in the U.S.

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

The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 36 participants, and 18 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.

Official Title

A Feasibility Study of Delivery of the 5-Step Method Intervention for Family Members of Persons With Substance Use Disorder in the United States

Quick Facts

Study Start:2024-09-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06565429

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * at least 18 years old
  2. * able to read, write, speak, and understand English
  3. * live in approximately 50-mile radius of Winchester, VA/ in the Northern Shenandoah Valley
  4. * be a family member who self-reports stress/strain because of a relative's drug and/or alcohol misuse
  5. * have access to the Internet and a smartphone or larger device to complete study surveys
  6. * Live with the relative with drug and/or alcohol problems or have at least 3 points of contact with them weekly
  7. * have a personal email address they do not share with others that can receive study related emails
  8. * have the ability to freely consent to participate in the study based on their understanding
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Therese M Collins, MS, RN
CONTACT
5403363636
tcolli13@villanova.edu
Helene Moriarty, PhD, RN, FAAN
CONTACT
610-519-5735
helene.moriarty@villanova.edu

Principal Investigator

Therese M Collins, MS, RN
PRINCIPAL_INVESTIGATOR
Villanova University
Helene Moriarty, PhD, RN, FAAN
PRINCIPAL_INVESTIGATOR
Villanova University

Study Locations (Sites)

Online Study
Winchester, Virginia, 22601
United States

Collaborators and Investigators

Sponsor: Villanova University

  • Therese M Collins, MS, RN, PRINCIPAL_INVESTIGATOR, Villanova University
  • Helene Moriarty, PhD, RN, FAAN, PRINCIPAL_INVESTIGATOR, Villanova University

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 Date2024-09-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Social Support

Additional Relevant MeSH Terms

  • Family Members
  • Relatives
  • Substance-Related Disorders
  • Alcohol-Related Disorders
  • Coping Skills
  • Stress, Psychological
  • Stress Physiology