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 (MoDIDol)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Intellectual Developmental Disorder; Multiple Disabilities; Pain; Autism Disorder

Treatments: Procedure: MoDIDol intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07302048

29BRC24.0282

Details and patient eligibility

About

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.

Full description

The MoDIDol team intervenes at the request of parents or professionals in complex situations involving pain or behavioural problems suggestive of pain, unresolved despite previous treatment. Parents and professionals learn about the MoDIDol team through flyers and information provided by associations and organisations supporting people with disabilities (associations, CRDI, etc.).

Once they are included in the study and after consent has been signed, multidisciplinary follow-up consultations are carried out by the MoDIDol team for pain management (every 6 weeks).

At the same time, three data collection sessions are planned for the participants, 3 months apart. Questionnaires are completed at each point by dedicated study staff. Interviews are conducted at 6-month intervals among a representative sample of professionals and parents.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

children or young adults with IDD, ASD or multiple disabilities

Experimental group

Description:

Single arm study Interventions are : * parents education for NCCPC and PPP by a pain specialized nurse at T1 * parents fullfilling of questionnaires à T1, T2 and T3 with study engineer

Treatment:

Procedure: MoDIDol intervention