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

NCT07302048 | Recruiting

• 1 other identifier: 29BRC24.0282
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Disorder; Pain; Multiple Disabilities; Intellectual Developmental Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Global Clinical Improvement at 6 months

  The primary outcome is the patient's global clinical improvement as perceived by family caregivers and/or institutional professionals, using the Patient Global Impression of Change (PGIC) scale after 6 months of care provided by the MoDIDol team. Improvement is defined as a PGIC score of 1 or 2 out of 7. scale from 1 to 7, higher scores mean worse outcome.

  From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)

Secondary Outcomes (19)

• Global Clinical Improvement at 3 months

  From baseline to the end of 3 months of treatment with the MoDIDoL system, assessed up to 3 months (T2)

• Non Communicating Children's Pain Checklist (NCCPC) Pain Intensity Scores at T1, T2, and T3

  Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.

• Pediatric Pain Profile (PPP) Pain Intensity Scores at T1, T2, and T3

  Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.

• Non Communicating Children's Pain Checklist (NCCPC) Pain Category Change

  Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system

• Pediatric Pain Profile Pain Category Change

  Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system

Study Arms (1)

children or young adults with IDD, ASD or multiple disabilities

EXPERIMENTAL

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

Procedure: MoDIDol intervention

Interventions

MoDIDol intervention 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.

children or young adults with IDD, ASD or multiple disabilities

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Fondation de France: collaborator
• Université de Bretagne Occidentale, Brest-France: collaborator
• Fondation Perce Neige: collaborator

Study Sites (1)

CHU de Brest - Hôpital Morvan

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Pain; Intellectual Disability; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Philippe J LE MOINE, MD

  CHU de Brest

  PRINCIPAL INVESTIGATOR

• Amandine DUBOIS, PhD

  Université de Bretagne Occidentale

  STUDY DIRECTOR

Central Study Contacts

Philippe LE MOINE, MD

CONTACT

+332 98 22 39 56; philippe.lemoine@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MoDIDol is a monocentric, prospective, non-comparative interventional study

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: December 24, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): April 20, 2028
• Study Completion (Estimated): April 20, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)