The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial.
Alex Copello, Lorna Templeton, Jim Orford...
https://pubmed.ncbi.nlm.nih.gov/19133888Actively Recruiting
Led by Villanova University · Updated on 2025-05-23
36
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are evaluating the feasibility of introducing a behavioral intervention called the 5-Step Method for family members affected by a relative's misuse of drugs and/or alcohol in the United States. This randomized control trial will include 36 participants experiencing stress related to their relative's substance misuse for at least six months. The study aims to assess whether the 5-Step Method can be effectively introduced in the U.S. and to observe preliminary participant responses through baseline and follow-up surveys. Participants will be randomly assigned to either the intervention group or the control group. Those in the intervention group will receive a self-help handbook of the 5-Step Method delivered by mail, along with emails every two weeks encouraging continued use over a 12-week period. The control group will not receive the handbook from the research team but may seek out other available support programs independently. Recruitment will be ongoing until the study reaches 36 participants. During the study, participants will complete baseline and follow-up surveys to measure stress, coping, strain, and social support. Researchers will track adherence to the intervention, acceptability, ease of use, and any adverse events up to one year after completing the intervention. Data on recruitment, retention, and other process rates will also be collected. Participants need internet access and a device for completing surveys and receiving emails. Total participation lasts approximately 12 weeks.
CONDITIONS
Feasibility of the 5-Step Method in the U.S.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or virtual)
Duration - 12 weeks
Participants in the intervention group receive a self-help handbook and emails every two weeks to guide them through the 5-Step Method intervention at home, while control group participants continue their usual care without additional intervention.
Regular email contacts every two weeks; surveys at baseline and 12 weeks
Total: 1 location
1
Online Study
Winchester, Virginia, United States, 22601
Actively Recruiting
T
Therese M Collins, MS, RN
H
Helene Moriarty, PhD, RN, FAAN
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Alex Copello, Lorna Templeton, Jim Orford...
https://pubmed.ncbi.nlm.nih.gov/19133888Bryan J Weiner, Cara C Lewis, Cameo Stanick...
https://pubmed.ncbi.nlm.nih.gov/28851459