Clinical trial NCT06940908: Living With Guillain-Barré Syndrome as Children.
Official title: Experience of Guillain Barré Syndrome in Childhood: A French Multicentric Qualitative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Guillain Barré Syndrome
Guillain-Barré Syndrome (GBS)
Keywords: children
experience
qualitative study
quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from the population of children and adolescents who experienced Guillain-Barré Syndrome (GBS) during childhood and received medical care at one of two university hospitals in southern France: Toulouse University Hospital and Montpellier University Hospital. Eligible participants will be aged 10 years or older at the time of the study and must be between 2 and 5 years post-acute GBS episode. The population includes individuals with sufficient command of the French language to engage in a semi-structured interview exploring the long-term psychosocial impact of GBS. Both male and female participants will be considered, provided they meet the inclusion criteria and give informed consent (or assent with parental consent for minors).

Brief summary: The goal of this qualitative observational study is to explore the lived experience and psychological aftermath of children who were affected by Guillain-Barré Syndrome (GBS) two to five years earlier. GBS is a rare and acute neurological condition, and while motor recovery is generally good in children, residual symptoms such as fatigue, pain, anxiety, or depression may persist and impact quality of life.

The main questions it aims to answer are:

How do children experience and recall their illness and recovery after GBS? What psychological or contextual factors might contribute to emotional distress or depressive symptoms in the years following the disease?

Participants will:

Be children aged 10 or older who had GBS two to five years prior. Participate in a 45-60-minute semi-structured individual interview during a routine follow-up visit.

Respond to a screening questionnaire for depressive symptoms (Children's Depression Inventory or Beck Depression Inventory Fast Screen).

Undergo a brief clinical examination to assess any remaining physical sequelae. Interviews will be audio recorded, transcribed verbatim, and pseudonymized. Thematic reflexive analysis will be performed following Braun and Clarke's methodology. Recruitment will continue until theoretical saturation is reached (approximately 25 participants expected) across two centers (Toulouse and Montpellier).

This study aims to generate new insights into pediatric psychological outcomes after GBS, in order to improve acute care and follow-up, and potentially guide future mental health support for affected children.

Detailed description: Guillain-Barré Syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy that can lead to significant functional impairment. Although pediatric patients typically experience more favorable motor recovery compared to adults, emerging clinical observations suggest that psychological and sensory sequelae-such as fatigue, neuropathic pain, paresthesia, anxiety disorders, and major depressive episodes-may persist long after the acute phase.

To date, no qualitative research has specifically examined how children experience GBS and its aftermath, particularly years after recovery. The GUIREQUAL study is designed to fill this gap by using qualitative methods to explore long-term psychosocial impacts among pediatric GBS survivors, and to develop hypotheses regarding psychological vulnerability post-recovery.

This is a bicentric, prospective qualitative study conducted in two pediatric neurology centers (Toulouse and Montpellier, France). Participants will be identified from hospital records and must meet strict inclusion criteria, including a confirmed diagnosis of GBS or its variants (AIDP, AMAN, Miller Fisher), with onset 2 to 5 years prior to study enrollment. Patients with chronic inflammatory demyelinating polyneuropathy (CIDP), central nervous system involvement (e.g., Bickerstaff encephalitis), or unrelated chronic neurological/orthopedic diseases will be excluded to reduce confounding factors.

The data collection process includes:

A semi-structured, face-to-face interview (45-60 minutes) conducted during a routine follow-up visit, allowing the child (with or without parental presence, depending on age) to recount their illness experience in a supportive setting.

A brief validated screening tool to assess current depressive symptoms (CDI or BDI-FS).

A short clinical assessment by an independent clinician to evaluate any remaining physical sequelae.

Interviews will be audio-recorded, transcribed verbatim, and pseudonymized for confidentiality. Thematic reflexive analysis will be conducted following the Braun \& Clarke methodology. Transcripts will be coded iteratively, and themes will be developed inductively and refined throughout the study process, in accordance with qualitative research best practices. Data collection will continue until theoretical saturation is achieved (estimated at 25 participants), ensuring the robustness of thematic conclusions.

The research team will maintain a reflexive logbook to track methodological decisions, and triangulation will be employed across multiple researchers to enhance credibility. This approach is expected to yield a nuanced understanding of how children make sense of their illness experience and what psychosocial factors may contribute to long-term well-being or distress.

Ultimately, GUIREQUAL aims to generate new clinical hypotheses, inform psychosocial follow-up strategies, and potentially advocate for early mental health screening and support in pediatric GBS survivors.

Eligibility criteria: Inclusion Criteria:

* Children or adolescents aged 10 years or older at the time of the interview
* History of Guillain-Barré syndrome (GBS) diagnosed in childhood
* Time since acute episode: between 2 and 5 years
* Sufficient mastery of the French language to participate in a semi-structured interview
* Consent of the participant and, for minors, parental consent

Exclusion Criteria:

* Presence of a neurological disease other than GBS that may interfere with participation or interpretation of data
* Severe cognitive impairment preventing the child or adolescent from engaging in the interview

Primary outcomes:
measure: Child's psychological and emotional experience after Guillain-Barré Syndrome
timeFrame: From 6 months to 5 years after the acute Guillain-Barré episode
Secondary outcomes:
measure: Child's perception of hospitalization and medical care during Guillain-Barré Syndrome
timeFrame: From 6 months to 5 years after the acute Guillain-Barré episode
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
state: Occitanie
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Occitanie
Study officials:
References: