Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06082089
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-10-09
Brief Title:
Divorce Adjustment Program for Women
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
A Structured and Empirically Validated Multidimensional Intervention Program to Improve Postdivorce Adjustment and Psychological Well-Being for Divorced Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
This study is the randomized controlled trial RCT part of a broader project aiming to develop and evaluate the effectiveness and feasibility of a structured culture-sensitive brief divorce adjustment program DAP for women The present pilot RCT will be the first to test the potential effectiveness of the DAP to be delivered in an online group format in comparison to a wait-list control group The feasibility of the program will be evaluated considering the percentages of attendance to the sessions drop-out rates and qualitative assessments at the end of each session as well as at the end of the program
Detailed Description:
Considering the current pattern of rising divorce rates in all over the world multi-dimensional culturally-sensitive and well-structured interventions available for people in the post-divorce period has crucial importance in clinical practice The divorce adjustment program DAP is such an group intervention that is designed in the previous stage of this study to improve the level of postdivorce adjustment and psychological well-being
The main purpose of this study is to test the potential effectiveness of the DAP to be delivered in an online group format for Turkish women who might undergo a more challenging adaptation process than that of men as indicated by the relevant literature The DAP is a 5-module intervention for women without children and has an extra children-focused module making the program 6 modules for women with children
Since the DAP has not been used andor tested before this study will be designed as a pilot RCT in which the program will be implemented in an online group format to Turkish divorced women reporting adjustment difficulties as determined by having scores on the Fisher Divorce Adjustment Scale-Short Form FDAS-SF below the average that of reported in the Turkish adaptation study The potential effectiveness of the DAP will be tested compared to a wait-list control group with delayed intervention On taking baseline assessments eligible 60 participants with children and 60 participants without children will separately be randomized to either the experimental DAP group n 30 for women with children n 30 for women without children or to the wait-list control group n 30 for women with children n 30 for women without children If the time gap between baseline assessment and the first DAP session exceeds 1-week period the pre-intervention assessments will be recurred The effectiveness of the program will be evaluated by means of various measurements to be taken before the intervention immediately after the completion of the program and at 1-month and 3-month follow-ups All divorced women including drop-outs will be invited to outcome assessments After completion of the follow-up assessment the wait-list participants will be given opportunity to choose either participation to the DAP or receiving booklets including detailed information about the DAP content The primary outcome measure will be divorce adjustment score and depression anxiety stress life satisfaction psychological well-being and ego strength measures will be the secondary outcomes
The feasibility of the program will be evaluated by assessing the percentages of attendance to the sessions drop-out rates and qualitative assessments at the end of each session as well as at the end of the program
The main purpose of this study is to test the potential effectiveness of the DAP to be delivered in an online group format for Turkish women who might undergo a more challenging adaptation process than that of men as indicated by the relevant literature The DAP is a 5-module intervention for women without children and has an extra children-focused module making the program 6 modules for women with children
Since the DAP has not been used andor tested before this study will be designed as a pilot RCT in which the program will be implemented in an online group format to Turkish divorced women reporting adjustment difficulties as determined by having scores on the Fisher Divorce Adjustment Scale-Short Form FDAS-SF below the average that of reported in the Turkish adaptation study The potential effectiveness of the DAP will be tested compared to a wait-list control group with delayed intervention On taking baseline assessments eligible 60 participants with children and 60 participants without children will separately be randomized to either the experimental DAP group n 30 for women with children n 30 for women without children or to the wait-list control group n 30 for women with children n 30 for women without children If the time gap between baseline assessment and the first DAP session exceeds 1-week period the pre-intervention assessments will be recurred The effectiveness of the program will be evaluated by means of various measurements to be taken before the intervention immediately after the completion of the program and at 1-month and 3-month follow-ups All divorced women including drop-outs will be invited to outcome assessments After completion of the follow-up assessment the wait-list participants will be given opportunity to choose either participation to the DAP or receiving booklets including detailed information about the DAP content The primary outcome measure will be divorce adjustment score and depression anxiety stress life satisfaction psychological well-being and ego strength measures will be the secondary outcomes
The feasibility of the program will be evaluated by assessing the percentages of attendance to the sessions drop-out rates and qualitative assessments at the end of each session as well as at the end of the program
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