Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa (EMA-FRaM)

May 7, 2026 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Recruiting

Conditions

Anorexia Nervosa

Intervention / Treatment

Other: sibling group

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 Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Antoine STOCKER, MD
Phone Number: 05 61 77 22 33
Email: stocker.a@chu-toulouse.fr

Study Locations

France
- - Toulouse, France
    - Recruiting
    - Uh Toulouse
    - Contact:
      
      Amélie Poinsard, MD RESIDENT
      
      Phone Number: 06.76.61.18.66
      
      Email: amelie.poinsard@free.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

inclusion criteria : Sibling presenting a DSM (Diagnostic and Statistical Manual)-5 of Mental Disorders diagnosis of AN, and engaged in inpatient or outpatient healthcare
exclusion criteria :
- (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after attending group sessions, maximum 3 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the groups on quality of life Time Frame: baseline	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	baseline
impact of the groups on quality of life Time Frame: after attending group sessions, maximum 3 months after baseline	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	after attending group sessions, maximum 3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

Principal Investigator: Antoine STOCKER, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

August 2, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RC31/24/0181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.