Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565429
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Feasibility of the 5-Step Method in the US
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relatives misuse of drugs andor 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 US 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 US 2 to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response
Detailed Description:
The study will be implemented in the Northern Shenandoah Valley area A participant in the study will be an affected family member of someone with drug andor alcohol misuse who has been experiencing stress as a result of the substance misuse for at least the past six months Both stress and their relatives misuse will be self-identified by the participant Recruitment for the study will include advertisements via social media local newspaper notices and flyers posted at stores and healthcare sites Once potential participants have contacted the PI and have been screened consented and have completed the baseline survey they will be randomized into either the intervention group or the control group Once randomized the participant and PI will no longer be blinded to the treatment condition Those in the intervention group will receive the self-help handbook via the US mail The control group does not receive an intervention but could use currently available programs if desired although information about these programs will not be provided by the PI All participants will receive emails at regular intervals during their 12-week study period Because the intervention is completed at the individual level study recruitment will occur on a rolling basis until 36 participants have been enrolled Data regarding the feasibility of the study recruitment retention refusal rates etc will be collected Baseline and follow up surveys will be compared for evidence of participant response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None