Menu
Recruiting 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

No phase Interventional Autism Disorder Multiple Disabilities Pain Intellectual Developmental Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MoDIDol intervention.
Who it may be relevant to
Registry conditions: Autism Disorder, Multiple Disabilities, Pain, Intellectual Developmental Disorder. Basic parameters: up to 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure 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.

Primary outcome measures

  • Global Clinical Improvement at 6 months [Time frame: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)]
Secondary outcome measures (12)
  • Global Clinical Improvement at 3 months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
  • Pediatric Pain Profile Pain Category Change [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
  • Non Communicating Children's Pain Checklist (NCCPC) Pain Behavior Profiles [Time frame: Baseline (T1)]
  • Pediatric Pain Profile Pain Behavior Profiles [Time frame: Baseline (T1)]
  • Behavioral Disturbance Evolution [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.]
  • PedsQL Patient Quality of Life Scores [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
  • PolyQoL Patient Quality of Life Scores [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
  • Sleep Quality Scores [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
  • Parental Quality of Life [Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Brest - Hôpital Morvan — Brest

Identifiers

NCT: NCT07302048 · 29BRC24.0282

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗