NCT04370964

Brief Summary

The proposed study focuses on the relational characteristics of the family and their evolution in the course of family therapy, through the evolution of the family alliance (degree of coordination achieved by its members to perform a task) and co-parenting (support that the mother and father give each other in their roles as parents), assuming that the family therapy allows the improvement of these two aspects. The family alliance is evaluated via a standardized observation situation (Lausanne Family Play LFP adapted from the Lausanne Trilogy Play LTP) whose sessions are filmed. The alliance assessment is carried out by the coding and scales of the FASS (Family Alliance Assessment Scales,) tool during viewing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 28, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

family alliance-family relionship-co-parenting-Lausanne Trilogy Play LTP

Outcome Measures

Primary Outcomes (11)

  • Family Alliance Assessment Sales (FASS)

    Scale validated in French evaluating the family alliance when viewing Lausanne Trilogy Play

    Between "month 1" and "month 3"

  • Family Adaptability and Cohesion Evaluation Scales for adolescents(FACES III)

    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)

    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)

    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)

    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)

    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)

    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)

    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

  • Family Attitude Scale, l'échelle d'attitude familiale (FAS-30)

    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)

    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

  • Child Behavior Check List (CBCL)

    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 Outcomes (2)

  • Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).

    At baseline

  • Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).

    At month 9

Other Outcomes (6)

  • Mchale Co-parenting Scale

    at baseline

  • Mchale Co-parenting Scale

    at month 9

  • Dyadic Adjustment Scale (DAS)

    at baseline

  • +3 more other outcomes

Study Arms (1)

Family with young aged people

OTHER

The family will be evaluated in two stages via the standardized situations LTP (parents and patient) and LFP (family) as well as self-assessments

Other: Lausanne Trilogy PlayOther: Lausanne Family Play

Interventions

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.

Also known as: LTP
Family with young aged people

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.

Also known as: LFP
Family with young aged people

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPS Ville Evrard

Aubervilliers, 93300, France

Location

Study Officials

  • Marie-Christine Beaucousin, MBBS

    CHVille Evrard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The family will be evaluated in two stages via the standardized situations LTP (parents and patient) and LFP (family) as well as self-assessments, before the start of the therapy then after 9 months of therapy, each family being its own control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist, head of the clinical research department

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 1, 2020

Study Start

March 5, 2019

Primary Completion

March 5, 2021

Study Completion

September 5, 2021

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations