- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05331352
Attachment Style and Mentalization Impact Among Women Victims of Domestic Violence (FEMATAM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rose-Angelique Belot, PhD
- Phone Number: 03 81 66 54 70
- Email: rose-angelique.belot@univ-fcomte.fr
Study Contact Backup
- Name: Justine CESARI, Student
- Phone Number: 06 16 10 28 98
- Email: justinecesari53@hotmail.fr
Study Locations
-
-
Bourgogne Franche-Comté
-
Besançon, Bourgogne Franche-Comté, France, 25000
- Recruiting
- CHU Besançon
-
Contact:
- Justine CESARI, Student
- Phone Number: 06 16 10 28 98
- Email: justinecesari53@hotmail.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women over 20 years old, victims of domestic violence
- With european culture
- Separated from their abusive partner
- Consulting the Legal Medicine Department in Besançon University Hospital
Exclusion Criteria:
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Subjects following a psychotherapy
Domestic violence victims following a psychotherapy 15 subjets Aged from 20 to 55
|
Interview
Rorschach + thematic aperception test
RSQ - PBI - RFQ - QSCPGS - SSQ6 - ÉCHELLES DE CUNGI - STAI - PCL-S - IES-R
|
|
Experimental: Subjects unfollowing a psychotherapy
Domestic violence victims unfollowing a psychotherapy 15 subjects Aged from 20 to 55
|
Interview
Rorschach + thematic aperception test
RSQ - PBI - RFQ - QSCPGS - SSQ6 - ÉCHELLES DE CUNGI - STAI - PCL-S - IES-R
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Security of the current attachment
Time Frame: Month 12
|
Relationship Scale Questionary (RSQ) Description : 30 questions Answers : - 5 (not like me at all to) + 5 (very like me) Cotation : self-model scale : - 4 to + 4 model of others : - 4 to + 4 positive self-model and positive model of others = secure positive self-model and negative model of others = insecure detached negative self-model and positive model of others = insecure worried negative self-model and negative model of others = insecure fearful |
Month 12
|
|
Security of the early attachment
Time Frame: Month 12
|
Adult Attachment Interview (AAI : Main, George & Kaplan, 1984 ; Pierrehumbert et al., 1999) Description : 20 questions Free answers Cotation : Edicode, Pierrehumbert Fluidity = 1 to 9 Coherence = 1 to 9 Reflexive = 1 to 9 Authentic = 1 to 9 Scores have to be high |
Month 12
|
|
Mentalization
Time Frame: Month 12
|
The Reflective Functioning Questionnaire (RFQ : Fonagy & al., 2016) The 8-item RFQ Reflective Functioning Questionnaire comprises two subscales each of 6 items (Uncertainty and Certainty about mental states) The two scales operate with a Likert scale of 7 points that evaluate the degree of agreement of the subject with the sentences presented in each item. The items of Uncertainty or RFQ_U correspond to statements such as "Often very strong feelings cloud my thinking", they are recorded to detect extreme levels of uncertainty about mental states, in the following way 0, 0, 0, 0, 1, 2, 3, so that high scores reflect hypomentalization. Scores have to be medium The items corresponding to Certainty of mental states or RFQ_C contemplate statements such as "When I get angry I say things without really knowing why I say them" which are recorded as 3, 2, 1, 0, 0, 0, 0, in such a way that a 6 low degree of agreement reflects Hypermentalization. Scores have to be medium |
Month 12
|
|
Quality of early relationship
Time Frame: Month 12
|
Parental Bonding Instrument (G. Parker, H. Tupling and R.B. Brown) Two scales termed 'care' and 'overprotection' or 'control', measure fundamental parental styles as perceived by the child. 25 item questions, including 12 'care' items and 13 'overprotection' items. Likert scale : "very like" (+3) or very dislike (-3). In addition to generating care and protection scores for each scale, parents can be effectively "assigned" to one of four quadrants: Mothers : care score = 27.0 / protection score = 13.5. Fathers :care score = 24.0 / protection score = 12.5. High care and high protection means "affectionate constraint". High protection and low care means "affectionless control". High care and low protection means "optimal parenting". Low care and low protection means "neglectful parenting". |
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD
Time Frame: Month 12
|
Cungi's Scale 8 items Subject evaluates the importance for him of each of the items with a rating ranging from 1, very little impact at 6, extremely high impact. Score have to be low State-Trait Anxiety Inventory (STAI : Spielberg, 1983) Measures how the subject feels right now on 40 items with answer choices of 1 = not at all / almost never, 2 = somewhat/sometimes, 3 = moderately so / often, and 4 = very much so / almost always. Item scores are added to obtain subtest total scores. The score range for each subtest is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms. Impact of Event Scale Revisited (IES-R : Horowitz, Wilner, & Alvarez, 1979) 7 additional questions and a scoring range of 0 to 88. Scores that exceed 24 can be quite meaningful 33 and above : PTDS |
Month 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The social support
Time Frame: Month 12
|
The social support questionnaire SSQ6 (Sarason et al., 1987) 6-item measure of social support. For each of the 6 items, respondents indicate the number of people available to provide support in each of 6 areas and then rate the overall level of satisfaction with the support given in each of the areas. For each item, the respondent makes a list of the people he can count on in the situation described (maximum 9 people) and expresses his degree of satisfaction (from 1 to 6) with this support. We then calculate two total scores, one of availability (N=number of people cited) and the other satisfaction (S), which correspond respectively to the sum of the "number" (N score) and "satisfaction" (S score) scores obtained in each of the six items. N score varies from 0 to 54 and the S score from 6 to 36. Both scores must be as high as possible |
Month 12
|
|
The self-satisfaction
Time Frame: Month 12
|
The self-satisfaction with the body satisfaction and global self-perception questionnaire (QSCPGS) Total score ranges from -100 to +100, each of the 20 items ranging from -5 to +5. The sign of value surrounded is a function of the proposal he has chosen to define himself. The sum of the 20 values gives the total score. If three or more answers lack, the QSCPGS is not valid. For quality analysis, the calculation of the number of hits, negative replies and neutral gives an indication of the perception that the subject of himself. This value is given as a percentage positive, negative and neutral. An item analysis by item, as well as the total and both factors can be considered. |
Month 12
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Houari Maïdi, PhD, Université de Bourgogne Franche-Comté
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020/546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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