Family RelationsLTPNCT04370964
Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process
A study testing Lausanne Trilogy Play and Lausanne Family Play in people with Family Relations, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Relations
- What is being tested?
- Lausanne Trilogy Play and Lausanne Family Play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2019to 5 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process: Prospective Pilot Study
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.
- Conditions
- Family Relations
- Being tested
- Lausanne Trilogy Play, Lausanne Family Play
- Keywords
- family alliance-family relionship-co-parenting-Lausanne Trilogy Play LTP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lausanne Trilogy PlayOther
Also called LTP
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.
Lausanne Family PlayOther
Also called LFP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Lausanne Trilogy Play; Other: Lausanne Family Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Alliance Assessment Sales (FASS)
Scale validated in French evaluating the family alliance when viewing Lausanne Trilogy Play
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: at month 9
Secondary outcomes (2)
Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
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".
Measured: At baseline
Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
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".
Measured: At month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start5 Mar 2019
- Primary completion5 Mar 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Marie-Christine Beaucousin, MBBS, Principal investigator, CHVille Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370964
- Sponsor's protocol ID
- 10477M-LTP
- Acronym
- LTP
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process: Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04370964
- Acronym / sponsor ID
- LTP / 10477M-LTP
- Conditions
- Family Relations
- Keywords
- family alliance-family relionship-co-parenting-Lausanne Trilogy Play LTP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 5 Mar 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family with young aged people | Other | Other: Lausanne Trilogy Play, Other: Lausanne Family PlayThe family will be evaluated in two stages via the standardized situations LTP (parents and patient) and LFP (family) as well as self-assessments |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lausanne Trilogy PlayAlso: LTPTrilogical 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 | Family with young aged people |
| Lausanne Family PlayAlso: LFPLausanne 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 | Family with young aged people |
Primary outcome
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
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
2 secondary outcomes
Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
Time frame: At baseline
Security in the inter parental subsystem: le questionnaire de sécurité dans le sous- système parental (SIS).
Time frame: At month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine Beaucousin, MBBS principal investigator
CHVille Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lausanne Trilogy Play and Lausanne Family Play in people with Family Relations, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Alliance Assessment Sales (FASS) (time frame: Between "month 1" and "month 3"). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.