Anorexia NervosaEMA-FRaMNCT06528158
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
An observational study of Anorexia Nervosa, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Anorexia nervosa (AN) is a complex mental disease with a huge impact on the patient's siblings life and well-being. Based on literature, group interventions for siblings of children suffering from a chronic disease could provide an effective support. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- sibling group
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 2 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- Child, Adult
Study population: Maximum 24 participants will overall be included to attend group sessions. Around 15 participants will be invited to an individual interview after group sessions.
Who may be able to join
None listed.
Who cannot join
- (1) Opposition from the participant and/or from their legal representatives.
- (2) Non-fluent French speaker
- (3) Clinical presentation not compatible with the group sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH Toulouse
Toulouse
Amélie Poinsard, MD RESIDENT, 06.76.61.18.66, amelie.poinsard@free.fr
About this study
Official title: Sibling Group for Children and Teenagers Living With a Sibling Who Suffers From Anorexia Nervosa: a Pilot Acceptability Study
Anorexia nervosa (AN) is a complex mental disease with a huge impact on the patient's siblings life and well-being. Based on literature, group interventions for siblings of children suffering from a chronic disease could provide an effective support. A few have been studied, and even fewer exist for siblings of children with AN.
Read the detailed description
AN has a significant impact on nuclear family (parents and siblings). An emerging literature highlights the need for a particular attention to siblings. Despite this evidence, research and clinical applications still lack in this area. Indeed, most of health services in AN offer support for patients, family, parents, but only few specific support for siblings, although positive outcomes of sibling group interventions were reported in other somatic and psychic disabilities.
Noting the gap between the need and the lack of specific support, the study hypothesis is that the poor diffusion of these interventions in AN might result from a low acceptability. The study propose to explore acceptability to adapt and improve group intervention for siblings of children and teenagers receiving care for anorexia nervosa.
The study is a mixed-method pilot study assessing the acceptability of a group intervention by including a maximum of 24 siblings of children suffering from AN, aged from 8 to 18, across three group sessions, each consisting of 4 meetings. All participants will be invited to fulfill two different auto-questionnaires about their quality of life (before and after group session) and the intervention's acceptability (after group session).
Quantitative data will be complemented with qualitative data, collected from individual semi-structured interviews with a targeted sampling among group participants.
- Conditions
- Anorexia Nervosa
- Being tested
- sibling group
- Keywords
- siblings, groups, children, teenagers, acceptability
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sibling groupOther
The group will be based on a systemic model and led by two child psychiatrists trained in family and multi-family therapy, who will not subsequently be involved in the data analysis. It will consist of 4 sessions of 1h30, spread over a period of 2 months, with a maximum of 8 participants per session. The first 3 sessions will be spaced 15 days apart, and the last session will take place 3 weeks apart from the third session.
The characteristics of the group (frequency, duration, number of sessions and participants) were built on data from the literature as well as on clinical feedback from a first pilot group conducted in January and February 2024 on the Toulouse pediatric unit by the two therapists who will lead the groups during the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Group ACCEPTABILITY
assess the clinical setting " sibling group "'s acceptability among siblings of teenagers engaged in health care for AN. This will be assessed through the acceptability scale Abbreviated Acceptability Rating Profile (AARP) after attending group sessions.
In the questionnaire, there are 8 questions. For each, a scale of 1 to 6, with 1 being "not agreeing at all with the question" and 6 being "completely agree". Maximum score = 48 the higher the score, the better the acceptability of the group is felt by participants.
Measured: after attending group sessions, maximum 3 months after baseline
Secondary outcomes (2)
Impact of the groups on quality of life
THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.
The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.
The PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us
Measured: baseline
impact of the groups on quality of life
THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.
The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.
The PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us
Measured: after attending group sessions, maximum 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start2 Jan 2025
- Primary completion2 Aug 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine STOCKER, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528158
- Sponsor's protocol ID
- RC31/24/0181
- Acronym
- EMA-FRaM
- Status last verified
- Nov 2026
- First submitted
- 25 Jul 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sibling Group for Children and Teenagers Living With a Sibling Who Suffers From Anorexia Nervosa: a Pilot Acceptability Study
- ClinicalTrials.gov ID
- NCT06528158
- Acronym / sponsor ID
- EMA-FRaM / RC31/24/0181
- Conditions
- Anorexia Nervosa
- Keywords
- siblings, groups, children, teenagers, acceptability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
Anorexia nervosa (AN) is a complex mental disease with a huge impact on the patient's siblings life and well-being. Based on literature, group interventions for siblings of children suffering from a chronic disease could provide an effective support. A few have been studied, and even fewer exist for siblings of children with AN.
Detailed description
AN has a significant impact on nuclear family (parents and siblings). An emerging literature highlights the need for a particular attention to siblings. Despite this evidence, research and clinical applications still lack in this area. Indeed, most of health services in AN offer support for patients, family, parents, but only few specific support for siblings, although positive outcomes of sibling group interventions were reported in other somatic and psychic disabilities.
Noting the gap between the need and the lack of specific support, the study hypothesis is that the poor diffusion of these interventions in AN might result from a low acceptability. The study propose to explore acceptability to adapt and improve group intervention for siblings of children and teenagers receiving care for anorexia nervosa.
The study is a mixed-method pilot study assessing the acceptability of a group intervention by including a maximum of 24 siblings of children suffering from AN, aged from 8 to 18, across three group sessions, each consisting of 4 meetings. All participants will be invited to fulfill two different auto-questionnaires about their quality of life (before and after group session) and the intervention's acceptability (after group session).
Quantitative data will be complemented with qualitative data, collected from individual semi-structured interviews with a targeted sampling among group participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Maximum 24 participants will overall be included to attend group sessions. Around 15 participants will be invited to an individual interview after group sessions.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| sibling groupThe group will be based on a systemic model and led by two child psychiatrists trained in family and multi-family therapy, who will not subsequently be involved in the data analysis. It will consist of 4 sessions of 1h30, spread over a period of 2 months, with a maximum of 8 participants per session. The first 3 sessions will be spaced 15 days apart, and the last session will take place 3 weeks apart from the third session. The characteristics of the group (frequency, duration, number of sessions and participants) were built on data from the literature as well as on clinical feedback from a first pilot group conducted in January and February 2024 on the Toulouse pediatric unit by the two therapists who will lead the groups during the study. | Other | – |
Primary outcome
Group ACCEPTABILITY
Time frame: after attending group sessions, maximum 3 months after baseline
assess the clinical setting " sibling group "'s acceptability among siblings of teenagers engaged in health care for AN. This will be assessed through the acceptability scale Abbreviated Acceptability Rating Profile (AARP) after attending group sessions. In the questionnaire, there are 8 questions. For each, a scale of 1 to 6, with 1 being "not agreeing at all with the question" and 6 being "completely agree". Maximum score = 48 the higher the score, the better the acceptability of the group is felt by participants.
2 secondary outcomes
Impact of the groups on quality of life
Time frame: baseline
impact of the groups on quality of life
Time frame: after attending group sessions, maximum 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Antoine STOCKER, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by University Hospital, Toulouse 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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine STOCKER, MD (05 61 77 22 33, stocker.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group ACCEPTABILITY (time frame: after attending group sessions, maximum 3 months after baseline). 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 5 Nov 2026.