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

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.

Global clinical improvement of the patient, as reported by caregivers and/or professionals, measured using the Patient Global Impression of Change (PGIC) scale after 3 months of MoDIDol care. Improvement is defined as a PGIC score of or 2 out of 7. Scale from 1 to 7, higher scores mean worse outcome.

Pain intensity will be assessed using the french version of Non Communicating Children's Pain Checklist (NCCPC) scale at baseline (T1), 3 months (T2), and 6 months (T3). The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.

Pain intensity will be assessed using the french version of Pediatric Pain Profile (PPP) scale at baseline (T1), 3 months (T2), and 6 months (T3). 20 behaviors are to be rated from 0 = not at all to 3 = completely. Pain is moderate to severe if score is 14/60 or above.

Patients will be categorized based on the french version of Non Communicating Children's Pain Chlecklist (NCCPC) (<6 : no pain; 6 to10 : mild pain; >10 : moderate to severe pain) scores to evaluate changes in pain category from T1 to T2 and T2 to T3. The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.

Patients will be categorized based on french version of Pediatric Pain Profile (PPP) (<14; > or =14) scores to evaluate changes in pain category from T1 to T2 and T2 to T3. Twenty behaviors are to be rated from 0 = not at all to 3 = completely. Pain is moderate to severe if score is 14/60 or above.

Behavioral indicators of pain will be documented using the item-based responses from Non Communicating Children's Pain Checklist (NCCPC) scale at T1. The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.

Behavioral indicators of pain will be documented using the item-based responses from Pediatric Pain Profile (PPP) scale at T1. Behaviours are to be assessed from 0 = not at all to 3 = completely (score from 0 to 60; pain if score > 14).

Frequency (0:never to 4: At least once an hour) and severity (1: mild to 3: severe) of three types of behaviors (self-injurious behaviors, stereotypical behaviors, and aggressive/destructive behaviors) will be assessed with the Behavior Problems Inventory (BPI) scale at T1, T2, and T3.

Quality of life will be assessed using Pediatric Quality of Life Inventory (PedsQL) for patients without profound disabilities on a five-point Likert scale (from 0: Never/Bad; to 4: Almost Always/Excellent) for 15 items at T1, T2, and T3.

Quality of life will be assessed using Quality of Life Scale for People with polyhandicap (PolyQoL) for patients with profound multiple disabilities on a five-point Likert scale (from 1: very bad; to 5: very goodt) for 21 items at T1, T2, and T3.

Sleep disorders will be measured with the Sleep Disturbance Scale for Children (SDSC) scale on a five-point Likert scale (from 1: never; to 5: every day) for 25 items at T1, T2, and T3.

Parental quality of life will be assessed using the World Health Organization Quality of Life (WHOQOL-BREF) across four domains rated on a 5-point Likert scale (score from 1 to 5) for 26 items at T1, T2, and T3.

Parental stress will be evaluated using the Parenting Stress Index (PSI-4) at T1, T2, and T3. This questionnaire includes 120 items divided in two categories (stressors associated with the child domain, or with de parent domain) rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score of stress is obtained by adding up the results. The higher the value is, the higher the stress.

Individual (e.g., diagnosis, development level, sensory profile) and environmental (e.g., living environment, type of care) factors will be analyzed in relation to PGIC (Patient Global Impression of Change) score at T3.

Pain causes will be described according to the mechanism (nociceptive, neuropathic, nociplastic), location, and etiology. Patients with intellectual deficiency are not able to describe their pain because of verbal impairment. Qualitative informations are available through parents and professionnal observations. Evaluation is based on physical examination, specialized medical advice (dental, ENT, ...) and additional examinations, such as laboratory or medical imaging, if needed. These description are build at T1 as hypothesis and may be specified depending on developments during treatment.

Description of treatments (indication and dosage) for pain and behavior at T2 and T3.

Internal consistency and structural validity of the french version of Non Communicating Children's Pain Checklist (NCCPC) (for patients with ASD) scale will be assessed.

Internal consistency and structural validity of the french version of Pediatric Pain Profile (PPP) scale will be assessed.

Impact of MoDIDol will be assessed through semi-structured interviews before (T1) and after (T3) of the intervention. Themes include daily impact of pain, beliefs, use of pain assessment tools, and perceived value of the mobile team