Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375876
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-16
Brief Title:
Single Session Intervention to Promote Hope
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Hope as a Path to Healing Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to develop a brief self-guided single-session intervention SSI that targets the development of or increase in hope and pilot test it for the primary outcomes of feasibility acceptabilitylikeability safety and changes in hope and the secondary outcomes of self-worth empowerment and emotional wellbeing among women experiencing intimate partner violence IPV The study will be conducted in 2 stages intervention development Intervention Development Stage and pilot testing the intervention Pilot Stage The focus of this registration is the Pilot Stage
Detailed Description:
This study aims to accomplish two primary objectives Objective 1 Intervention Development Stage Develop a brief self-guided SSI to enhance hope and in turn self-worth empowerment and emotional wellbeing and Objective 2 Pilot Stage Pilot test the intervention and evaluate the process of implementation and primary outcomes of feasibility acceptabilitylikability and safety and to assess changes in hope and secondary outcomes of self-worth empowerment and emotional wellbeing
The Pilot Stage will utilize micro-longitudinal methods ie daily self-reports of hope self-worth empowerment and emotional wellbeing for 14 days before and after the intervention to assess changes in these constructs Eligible participants will take part in a baseline interview with a member of the research team Baseline measures will be based on participant self-report and used to characterize the sample and collect data on person-level control variables Beginning the day after the baseline interview participants will complete a brief daily survey on their smartphone On day 15 participants will receive a link to the SSI and be asked to complete it that day immediately following the SSI participants will be asked to complete the post-intervention surveyprocess supplement to aid in the process evaluation After completion of the SSI survivors will participate in 14 additional days of daily data collection to establish post-intervention outcome measures
The Pilot Stage will utilize micro-longitudinal methods ie daily self-reports of hope self-worth empowerment and emotional wellbeing for 14 days before and after the intervention to assess changes in these constructs Eligible participants will take part in a baseline interview with a member of the research team Baseline measures will be based on participant self-report and used to characterize the sample and collect data on person-level control variables Beginning the day after the baseline interview participants will complete a brief daily survey on their smartphone On day 15 participants will receive a link to the SSI and be asked to complete it that day immediately following the SSI participants will be asked to complete the post-intervention surveyprocess supplement to aid in the process evaluation After completion of the SSI survivors will participate in 14 additional days of daily data collection to establish post-intervention outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15JOVW-22-GG-04755-STOP | OTHER_GRANT | Office on Violence Against Women OVW | None |