Clinical trial NCT06528158: Speech Groups for Children Living with a Sibling Who Suffers from Anorexia Nervosa
Official title: Sibling Group for Children and Teenagers Living with a Sibling Who Suffers from Anorexia Nervosa: a Pilot Acceptability Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: siblings
groups
children
teenagers
acceptability
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Group ACCEPTABILITY
timeFrame: after attending group sessions, maximum 3 months after baseline
Secondary outcomes:
measure: Impact of the groups on quality of life
timeFrame: baseline
measure: impact of the groups on quality of life
timeFrame: after attending group sessions, maximum 3 months after baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine STOCKER, MD
role: PRINCIPAL_INVESTIGATOR
References: