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

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2028-04-20

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.

Detailed 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.

Conditions

Autism Disorder; Multiple Disabilities; Pain; Intellectual Developmental Disorder

Keywords

Pain; Children; Adolescents; young adults; Intellectual Developmental Disability; Autism Spectrum Disorder; multiple disabilities; mobile team

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

children or young adults with IDD, ASD or multiple disabilities

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

Group Type: EXPERIMENTAL

MoDIDol intervention

Intervention Type: PROCEDURE

Multidisciplinary mobile intervention system specialising in pain management for patients with moderate to severe intellectual development disorders, isolated or associated with ASD or multiple disabilities.

Treatment recommendations, pain assessment, training in scales, follow-up consultations every 6 weeks for 6 months, continued if the situation is not resolved, call at 12 months.

Interventions

MoDIDol intervention

Multidisciplinary mobile intervention system specialising in pain management for patients with moderate to severe intellectual development disorders, isolated or associated with ASD or multiple disabilities.

Treatment recommendations, pain assessment, training in scales, follow-up consultations every 6 weeks for 6 months, continued if the situation is not resolved, call at 12 months.

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation de France

OTHER

Sponsor Role: collaborator

Université de Bretagne Occidentale, Brest-France

UNKNOWN

Sponsor Role: collaborator

Fondation Perce Neige

UNKNOWN

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe J LE MOINE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

Amandine DUBOIS, PhD

Role: STUDY_DIRECTOR

Université de Bretagne Occidentale

Locations

CHU de Brest - Hôpital Morvan

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe LE MOINE, MD

Role: CONTACT

Phone: +332 98 22 39 56

Email: philippe.lemoine@chu-brest.fr

Facility Contacts

Philippe J LE MOINE, MD

Role: primary

Other Identifiers

29BRC24.0282

Identifier Type: -

Identifier Source: org_study_id