NCT06528158

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jan 2025Aug 2026

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

July 25, 2024

Last Update Submit

May 7, 2026

Conditions

Keywords

siblingsgroupschildrenteenagersacceptability

Outcome Measures

Primary Outcomes (1)

  • 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.

    after attending group sessions, maximum 3 months after baseline

Secondary Outcomes (2)

  • Impact of the groups on quality of life

    baseline

  • impact of the groups on quality of life

    after attending group sessions, maximum 3 months after baseline

Interventions

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.

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Antoine STOCKER, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine STOCKER, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

January 2, 2025

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

August 2, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations