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| Name | Class |
|---|---|
| Fondation de France | OTHER |
| Université de Bretagne Occidentale, Brest-France | UNKNOWN |
| Fondation Perce Neige | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children or young adults with IDD, ASD or multiple disabilities | Experimental | Single arm study Interventions are :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Global Clinical Improvement at 3 months | 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. | From baseline to the end of 3 months of treatment with the MoDIDoL system, assessed up to 3 months (T2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe LE MOINE, MD | Contact | +332 98 22 39 56 | philippe.lemoine@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe J LE MOINE, MD | CHU de Brest | Principal Investigator |
| Amandine DUBOIS, PhD | Université de Bretagne Occidentale | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest - Hôpital Morvan | Recruiting | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.
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MoDIDol is a monocentric, prospective, non-comparative interventional study
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| Non Communicating Children's Pain Checklist (NCCPC) Pain Intensity Scores at T1, T2, and T3 | 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. | 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 | 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. | 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 | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system |
| Pediatric Pain Profile Pain Category Change | 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. | 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 | 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. | Baseline (T1) |
| Pediatric Pain Profile Pain Behavior Profiles | 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). | Baseline (T1) |
| Behavioral Disturbance Evolution | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system. |
| PedsQL Patient Quality of Life Scores | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system |
| PolyQoL Patient Quality of Life Scores | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system |
| Sleep Quality Scores | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system |
| Parental Quality of Life | 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. | Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system |
| Parental Stress | 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. | Baseline (T1), 3 months (T2), and 6 months (T3) |
| Determinants of Success | 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. | From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3) |
| Pain Mechanism, Localization, and Etiology | 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. | Pain mechanism, location and etiology are determined at T1 but can be revised during the 6 months patient follow up |
| Analgesic and Behavioral Treatments | Description of treatments (indication and dosage) for pain and behavior at T2 and T3. | From baseline to the end of 3 months (T2) and 6 months (T3) of treatment with the MoDIDol system |
| Psychometric Properties of Non Communicating Children's Pain Checklist (NCCPC) Scale | 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. | Through study completion, an average of 6 months after baseline. |
| Psychometric Properties of Pediaric Pain Profile Scale | Internal consistency and structural validity of the french version of Pediatric Pain Profile (PPP) scale will be assessed. | Through study completion, an average of 6 months after baseline. |
| Qualitative Interviews with Parents and Professionals | 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 | Baseline (T1) and after 6 months (T3) of treatment with the MoDIDol system |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D010146 | Pain |
| D008607 | Intellectual Disability |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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