Actively Recruiting
Impact and Success Factors of a Mobile Multidisciplinary Pain Management System for Patients With Intellectual Disability, Autism Spectrum Disorder, or Multiple Disabilities
Led by University Hospital, Brest · Updated on 2025-12-24
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Brest
Lead Sponsor
F
Fondation de France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pain is a major concern for children, adolescents, and young adults aged 0 to 25 years with Neurodevelopmental Disorders (NDD) such as Intellectual Developmental Disorder (IDD), Autism Spectrum Disorder (ASD), or multiple disabilities. These conditions often involve complex pain situations that are difficult to manage, and no validated pain management system currently addresses these needs comprehensively. The Mobile Pain Handicap Team Intellectual Disability (MoDIDol) was created at Brest University Hospital to provide a specialized, multidisciplinary approach to pain assessment and management in this population. The MoDIDol team includes a pediatrician specializing in pain and a nurse who visit patients in their usual living environments. The intervention involves parent education on pain assessment tools (NCCPC and PPP), multidisciplinary follow-up consultations every 6 weeks for 6 months, and continued care if necessary, with a follow-up call at 12 months. Parents complete questionnaires at baseline, 3 months, and 6 months to help guide the treatment and measure progress. Participants and their families engage in regular consultations and complete questionnaires to assess pain intensity, behavior, quality of life, and parental stress over the 6-month treatment period. Interviews with parents and professionals occur at 6-month intervals to gain further insights. The main outcome is the global clinical improvement measured at 6 months, along with various secondary outcomes such as pain profiles, behavioral changes, sleep quality, and treatment determinants. The study also monitors pain mechanisms and treatment adjustments during follow-up.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from birth up to 24 years inclusive
- Medical diagnosis of intellectual disability, isolated or with autism spectrum disorder, developmental disorder, or profound multiple disabilities
- Confirmed probable or definite pain diagnosis validated by the MoDIDol team
- PGIC score of 3 or higher
- Living in or receiving care in the departments of Finistère, Côtes-d'Armor, or Morbihan
- Written informed consent from parents, legal guardians, or holders of parental authority
- Affiliated with or benefiting from a French national health insurance scheme
You will not qualify if you...
- Having more than three places of residence and/or care settings
- Parents or legal guardians lacking sufficient language or comprehension skills to provide consent or complete study questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 6 months or longer if the situation is not resolved
Participants receive a multidisciplinary mobile intervention system specializing in pain management. Follow-up consultations are conducted every 6 weeks for 6 months, and continued if the situation is not resolved. Parents are educated about pain scales and complete questionnaires at baseline and during follow-ups.
Follow-up consultations every 6 weeks for 6 months; 3 data collection sessions 3 months apart
Trial Site Locations
Total: 1 location
1
CHU de Brest - Hôpital Morvan
Brest, France, 29200
Actively Recruiting
Research Team
P
Philippe LE MOINE, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here