- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370964
Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process (LTP)
Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process: Prospective Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aubervilliers, France, 93300
- EPS Ville Evrard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Families attended in family therapy by the G02 sector teams and the Bondy family therapy team attached to G14 and I05, with a designated adolescent patient (aged 12-18).
- Family whose parents or co-parents live under the same roof. Co-parents designate adults to be responsible for the care and education of one or more children (Talbot &Mchale, 2004)
- Blended families
Exclusion Criteria:
- Single parent family without co-parents (in-laws, grandparents...) living under the same roof
- Insufficient mastery of French
- Separated parents (lack of daily life is unsuitable for scales chosen)
- patient without social security scheme
- Persons in emergency situations.
- Persons unable to give their personal consent, of whom adults under guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Family with young aged people
The family will be evaluated in two stages via the standardized situations LTP (parents and patient) and LFP (family) as well as self-assessments
|
Trilogical game of Lausanne ("Lausanne Trilogue Play" in English abbreviated LTP), which allows an evaluation of the family alliance.
This systematic observation provides a "snapshot" of the family structure and its adaptive abilities.
It is based on the assumption that the ability to solve "small" tasks is representative of the ability to solve more important tasks.The LTP consists of modelling the different possibilities of interaction in a triad according to a four-part scenario: 1) one parent plays with the child, the other parent is simply present; 2) the parents switch roles; 3) both parents play together with the child; and 4) both parents have to talk together.
Other Names:
Lausanne Family Play (LFP) is a game situation adapted to families with more than one child.
Thus, like the LTP, the LFP takes place in four phases:1) one parent plays with siblings while the other is in a third-observer position; 2) the parents reverse their roles;3) children play while parents are talking and 4) family members play together.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Alliance Assessment Sales (FASS)
Time Frame: Between "month 1" and "month 3"
|
Scale validated in French evaluating the family alliance when viewing Lausanne Trilogy Play
|
Between "month 1" and "month 3"
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Family Adaptability and Cohesion Evaluation Scales for adolescents(FACES III)
Time Frame: At baseline
|
It consists of 40 items: a questionnaire for adolescents (40 items) .
It was designed to make it possible to "make a relational diagnosis" on the family and to bridge the gap between theory, research and practice in family psychology, based on the three dimensions that make up the "circomplexe" model.
|
At baseline
|
Family Adaptability and Cohesion Evaluation Scales for adolescents (FACES III)
Time Frame: at month "9"
|
It consists of 40 items: a questionnaire for adolescents (40 items) .
It was designed to make it possible to "make a relational diagnosis" on the family and to bridge the gap between theory, research and practice in family psychology, based on the three dimensions that make up the "circomplexe" model.
|
at month "9"
|
Family Adaptability and Cohesion Evaluation Scales for parents (FACES III)
Time Frame: At Baseline
|
It consists of 40 items: a questionnaire for parents (40 items).
It was designed to make it possible to "make a relational diagnosis" on the family and to bridge the gap between theory, research and practice in family psychology, based on the three dimensions that make up the "circomplexe" model.
|
At Baseline
|
Family Adaptability and Cohesion Evaluation Scales for parents (FACES III)
Time Frame: at month "9"
|
It consists of 40 items: a questionnaire for parents (40 items).
It was designed to make it possible to "make a relational diagnosis" on the family and to bridge the gap between theory, research and practice in family psychology, based on the three dimensions that make up the "circomplexe" model.
|
at month "9"
|
The Coparenting Inventory for Parents and Adolescents (CI-PA)
Time Frame: At Baseline
|
Validated in English, this scale was translated into French by the Favez team and is used by the Lausanne team for their LTP protocol with adolescents.
This is a Self Questionnaire of 38 items for the teenager and 25 items for the parents.
|
At Baseline
|
The Coparenting Inventory for Parents and Adolescents (CI-PA)
Time Frame: At month "9"
|
Validated in English, this scale was translated into French by the Favez team and is used by the Lausanne team for their LTP protocol with adolescents.
This is a Self Questionnaire of 38 items for the teenager and 25 items for the parents.
|
At month "9"
|
Family Attitude Scale, l'échelle d'attitude familiale (FAS-30)
Time Frame: At baseline
|
This questionnaire concerns thoughts and emotions that family members may have towards each other and is intended to assess the degree of hostility of the parent towards the patient.
Each item is rated according to its frequency, ranging from 4 (daily) to 0 (never).
There are 20 "negative" items (they refer to the parent's criticism of the patient and the burden they feel because of the patient) and 10 "positive" items (the patient's affection and positive feelings).
|
At baseline
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Family Attitude Scale, l'échelle d'attitude familiale (FAS-30)
Time Frame: At month 9
|
This questionnaire concerns thoughts and emotions that family members may have towards each other and is intended to assess the degree of hostility of the parent towards the patient.
Each item is rated according to its frequency, ranging from 4 (daily) to 0 (never).
There are 20 "negative" items (they refer to the parent's criticism of the patient and the burden they feel because of the patient) and 10 "positive" items (the patient's affection and positive feelings).
|
At month 9
|
Child Behavior Check List (CBCL)
Time Frame: at baseline
|
The CBCL is the most widely used questionnaire by researchers in the field of children's development and behaviour.
The CBCL has been translated and validated in several languages and intercultural studies have shown its relevance and richness.
It is validated and translated into French.
There is an adaptation for the school age group 6-18 years.
|
at baseline
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Child Behavior Check List (CBCL)
Time Frame: at month 9
|
The CBCL is the most widely used questionnaire by researchers in the field of children's development and behaviour.
The CBCL has been translated and validated in several languages and intercultural studies have shown its relevance and richness.
It is validated and translated into French.
There is an adaptation for the school age group 6-18 years.
|
at month 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
Time Frame: At baseline
|
Validated in English and reproduced and translated into French by Francesco Lopez and Favez Nicolas, this is a self-assessment for the teenager (43 Items) to evaluate the "emotional security system".
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At baseline
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Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
Time Frame: At month 9
|
Validated in English and reproduced and translated into French by Francesco Lopez and Favez Nicolas, this is a self-assessment for the teenager (43 Items) to evaluate the "emotional security system".
|
At month 9
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mchale Co-parenting Scale
Time Frame: at baseline
|
The French version of this parent self-assessment is validated and includes 16 questions plus a preliminary question (Frascarolo F, 2009) Depending on the questions they are asked, parents are sometimes asked to think about when they are with their spouse and child and sometimes when they are alone with their child.
They must estimate the frequency of certain behaviours.
|
at baseline
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Mchale Co-parenting Scale
Time Frame: at month 9
|
The French version of this parent self-assessment is validated and includes 16 questions plus a preliminary question (Frascarolo F, 2009) Depending on the questions they are asked, parents are sometimes asked to think about when they are with their spouse and child and sometimes when they are alone with their child.
They must estimate the frequency of certain behaviours.
|
at month 9
|
Dyadic Adjustment Scale (DAS)
Time Frame: at baseline
|
This is a scale widely used in research, validated in French (Antoine et al, 2008). It is composed of 16 items that explore two dimensions of the conjugal relationship: -the first dimension concerns the "degree of agreement in the couple", it is composed of 10 items relating to areas of divergence (divorce, annoyance) or convergence (common goals, joint attitude in relations with the environment). There are also items of affective expression, consensus and satisfaction. -The second dimension consists of six items and corresponds to the "quality of the dyadic interactions": the domains and the behaviors of exchange and partnership in the couple. |
at baseline
|
Dyadic Adjustment Scale (DAS)
Time Frame: at month 9
|
This is a scale widely used in research, validated in French (Antoine et al, 2008). It is composed of 16 items that explore two dimensions of the conjugal relationship: -the first dimension concerns the "degree of agreement in the couple", it is composed of 10 items relating to areas of divergence (divorce, annoyance) or convergence (common goals, joint attitude in relations with the environment). There are also items of affective expression, consensus and satisfaction. -The second dimension consists of six items and corresponds to the "quality of the dyadic interactions": the domains and the behaviors of exchange and partnership in the couple. |
at month 9
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The questionnaire on the developmental stages of families
Time Frame: at baseline
|
This is a questionnaire developed by Marie France Bradley and Robert Pauzé.It was conceived according to the developmental hypothesis of the family, which must, throughout its life cycle, go through a number of stages, namely: the departure from the house of the young single adult, the formation of the couple, the arrival of the children, the entry of children into adolescence, the departure of children from the family, the retirement of parents.
For each of these steps, the family needs to reorganize.
This instrument seeks to assess whether the developmental tasks they face have been carried out with more or less difficulty.
|
at baseline
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The questionnaire on the developmental stages of families
Time Frame: at month 9
|
We decided to pass only the part about the family with teenagers.
This part contains 43 items, corresponding to developmental tasks divided into 7 categories (support for the autonomy and responsibility of the adolescent, redefining the power of the parents vis-à-vis the adolescent, support for socialisation, support for the identity and personal development of the adolescent, impact of adolescence on the parental couple, multiple demands in adolescence and new issues in adolescence).
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at month 9
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Collaborators and Investigators
Investigators
- Principal Investigator: Marie-Christine Beaucousin, MBBS, CHVille Evrard
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
- 10477M-LTP
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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