Feasibility of the 5-Step Method in the U.S.
NCT Number: NCT06565429
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Family Members|Relatives|Substance-Related Disorders|Alcohol-Related Disorders|Coping Skills|Stress, Psychological|Stress Physiology
Interventions: BEHAVIORAL: 5-Step Method Intervention
Sponsor: Villanova University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-12-01

Summary:
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.

Primary Outcome Measures: Acceptability, Scores on Acceptability of Intervention Measure (Weiner et al., 2017), a validated and standardized instrument combined with eight other acceptability questions specific to the 5-Step Method Handbook., One year post completing the intervention|Study process rates, Study process rates will be assessed by quantitatively tracking the recruitment rate, retention rate, refusal rate, eligibility rate, and study completion rate., One year post completing the intervention. Rates will be tallied at the end of the study|Likelihood of adverse events, Safety will be assessed for all participants by quantitatively summarizing the number of adverse events that are considered to be unexpected, serious, and/or possibly or definitely related to the study, One year post completing the intervention|Resources, How much time all individual participants spent filling out the surveys, assessed via a survey, One year post completing the intervention|Adherence to treatment protocol, The adherence to treatment protocol will be assessed by asking the intervention group questions about how they interacted with the self-help handbook to determine if they used the handbook as designed or if they used it in some other way., 12 weeks after starting study, if placed in the intervention group|Marketing, Marketing of the study will be assessed by asking those who inquire about the study where they learned about the study to determine which locations may be better for recruitment in future studies., One year post completing the intervention. Will review responses and tally results|Ease of use, Ease of use of the study will be assessed by asking participants two questions at the end of the follow-up survey about the way the surveys were worded. The answers of these questions will be reviewed and tallied as well as qualitatively described. The surveys of the study are validated tools, and the only allowed changes to the survey questions were to change from UK English to US English on spelling alone (behaviour to behavior for example). Syntax and word choice were not allowed to be changed. It is possible that how the phrases are stated and the words used will not be as easy to read for an American as compared to someone from the UK, where the intervention was created. The two questions ask if there were any difficulties understanding the survey, and if so, did they think this may have affected how they answered any of the questions., One year post completing the intervention
Secondary Outcome Measures: Stress, Family Member Impact Questionnaire (FMI) Scores range from 0-48, with higher scores indicating higher stress., Baseline and change over 12 week period|Coping, Symptom Rating Test (SRT) Scores range from 0-90. There are three subscales of coping, with higher scores on two subscales generally associated with higher scores on stress and strain. One subscale is generally associated with lower scores on stress and strain., Baseline and change over 12 week period|Strain, Coping Questionnaire (CQ) Scores range from 0-60, higher scores indicating higher scores higher strain., Baseline and change over 12 week period|Social Support, Alcohol, Drugs, and the Family Social Support Scale (ADF-SSS) Scores range from 0-75 for the total score. Two subscales with higher scores show improved social support, while the third subscale should have lower numbers when there is an improvement., Baseline and change over 12 week period