NCT07302048 Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability
| NCT ID | NCT07302048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Autism Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2028-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-14 with a primary completion date of 2028-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. At present, there is no validated and tested pain management system in populations facing complex pain situations. In response to the lack of a pain management services, a multi-disciplinary mobile team was set up in September 2022 at the Brest University Hospital (Mobile Pain Handicap Team Intellectual Disability 0-25 years; MoDIDol). This team offers a specific protocol for the assessment and management of pain that takes into account the social and family environment, the living context and the clinical characteristics of patients (children, adolescents and young adults (0-25 years) with IDD, ASD or multiple disabilities). The team includes at least one paediatrician specialising in the assessment and treatment of pain and a nurse, and travels to patients' usual living environments.
Eligibility Criteria
Inclusion Criteria: * Aged from birth up to 24 years inclusive (i.e., under 25 years old) * Medical diagnosis of intellectual disability (ID), isolated or associated with autism spectrum disorder (ASD), developmental disorder (DD), or profound multiple disabilities, based on international classification systems (ICD-11 or DSM-5) * Confirmed probable or definite pain diagnosis, as validated by the MoDIDol team * PGIC score ≥ 3 * Living in or receiving care in the departments of Finistère, Côtes-d'Armor, or Morbihan * Written informed consent provided by parents, legal guardians, or holders of parental authority, authorizing data collection for research and publication purposes * Affiliated with or benefiting from a French national health insurance scheme Exclusion Criteria: * More than three places of residence and/or care settings * Parents or legal guardians who do not have sufficient language or comprehension skills to provide informed consent or complete study questionnaires
Contact & Investigator
Philippe J LE MOINE, MD
PRINCIPAL INVESTIGATOR
CHU de Brest
Frequently Asked Questions
Who can join the NCT07302048 clinical trial?
This trial is open to participants of all sexes, up to 24 Years, studying Autism Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07302048 currently recruiting?
Yes, NCT07302048 is actively recruiting participants. Contact the research team at philippe.lemoine@chu-brest.fr for enrollment information.
Where is the NCT07302048 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT07302048 clinical trial?
NCT07302048 is sponsored by University Hospital, Brest. The principal investigator is Philippe J LE MOINE, MD at CHU de Brest. The trial plans to enroll 80 participants.