Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05331352
Other study ID # 2020/546
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2023

Study information

Verified date April 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Rose-Angelique Belot, PhD
Phone 03 81 66 54 70
Email rose-angelique.belot@univ-fcomte.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Attachment and mentalization with a population of domestic violence victims Domestic violence is one of the most common forms of domestic violence. Multiform and complex, it affects all backgrounds and all ages. According to a survey instituted by the government of Emmanuel Macron, 219,000 women were recognized as victims of domestic violence in 2017. This phenomenon is not without questioning the scientific scene. Also, this study focus on the quality of the attachment because if this bond is insecure, it can constitute a point of vulnerability in self-construction and impact on future relational modalities.


Description:

The security of the bond of attachment depends on the capacity of the maternal figure, or her substitute, to understand and respond in an adapted and consistent manner to her baby. In addition, it has also been established that when disruptions occur in the security of attachment bond, the quality of mentalization is impacted. But, mentalization is the quality and quantity of psychic representations available to allow someone understanding and thinking about his links to others and to himself. This is an essential asset in the release of situations of violence and in overcoming trauma because it participates in psychic development. That's why this research focuses on early relationships and the quality of mentalization with a cohort of thirty women victims of domestic violence, consultant within the Legal Medicine department of the CHU of Besançon. This research focuses on two groups of subjects: women who managed to get out of violent relationship (15 subjects) and others who did not (15 subjects). The research methodology includes several tools: two projective tests (Rorschach and TAT), ten self-questionnaires (which assess attachment, stress, social support, relational quality with the main attachment figures, the image of the Self-body, quality of mentalization), a clinical research interview and presentation of the AAI. The observation of this population will highlight the impact of the early environment in the psychic construction of the subject and the victim's destiny. Moreover, this study will look at the role of psychotherapeutic follow-up in the quality of mentalization.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Semi-structured interviews
Interview
Projective methode
Rorschach + thematic aperception test
Selfreported
RSQ - PBI - RFQ - QSCPGS - SSQ6 - ÉCHELLES DE CUNGI - STAI - PCL-S - IES-R

Locations

Country Name City State
France CHU Besançon Besançon Bourgogne Franche-Comté

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon University of Franche-Comté

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other The social support 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
Other The self-satisfaction 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
Primary Security of the current attachment 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
Primary Security of the early attachment 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
Primary Mentalization 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
Primary Quality of early relationship 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 PTSD 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
See also
  Status Clinical Trial Phase
Completed NCT06284148 - Confidential IPV Screening Tool N/A
Completed NCT04095429 - Expect Respect Middle School Randomized Trial N/A
Recruiting NCT06100679 - Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation N/A
Completed NCT05417919 - Solution-oriented Nursing in Violence Against Women (SONVAW) N/A
Completed NCT04625465 - Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence N/A
Not yet recruiting NCT06350383 - Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention N/A
Completed NCT03259646 - The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women N/A
Not yet recruiting NCT06124950 - A Couple-based Gender-transformative Intervention on IPV Against Infertile Women N/A
Not yet recruiting NCT06330753 - Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan N/A
Not yet recruiting NCT05310656 - Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women N/A
Recruiting NCT03623555 - Applied Social Neuroscience: the Building Resilience Among Women Project
Recruiting NCT05608421 - 1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV N/A
Recruiting NCT05609786 - Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya N/A
Recruiting NCT06001307 - Supporting Trans Affirmation, Relationships, and Sex, Phase 3 N/A
Recruiting NCT05768217 - Community Resiliency Collective Efficacy Intervention N/A
Completed NCT04950686 - Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students N/A
Completed NCT03539315 - Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh N/A
Recruiting NCT03498638 - Feasibility Study of Couple Therapy Treatment for Situational Couple Violence N/A
Recruiting NCT04098276 - It's WeWomen Plus Intervention for Health, Safety and Empowerment N/A
Completed NCT05163171 - Prevalence of the Victimization and the Perpetration of Intimate Partner Violence Among the Patients From Puy-de-Dôme and Paris Consulting or Being Hospitalized for Addiction Problems and Their Expectations From General Practitioners (VIA-MG)