Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT06528158
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech Groups for Children Living with a Sibling Who Suffers from Anorexia Nervosa
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Sibling Group for Children and Teenagers Living with a Sibling Who Suffers from Anorexia Nervosa: a Pilot Acceptability Study
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMA-FRaM
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: