Fragility Assessment in Adults With ADHD and Mental Retardation

NCT02791321 | Completed

• 1 other identifier: 9691
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the phenotypic model (5 clinical criteria) or the cumulative model (various clinical and biological criteria). Currently, aging with autism spectrum disorder and mental retardation (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may present an early aging. Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20 years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with details health according to age, and to verify the frailty index validity for predicting falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years. This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time of inclusion. Frailty index is calculated from 104 clinical and biological criteria. Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale, DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year during 5 years. The connection between frailty index and age will be studied using linear regression. The frailty index validity will be analysed using ROC curves. Modelisation of the falls, hospitalisations or death risk in the 5 years after the initial evaluation will help in identification of the more frailty predictive criteria.

Conditions

Autism Spectrum Disorder; Mental Retardation

Outcome Measures

Primary Outcomes (1)

• Frailty index

  this correspond to the frailty cumulative model : 104 clinical and biological criteria are collected. IF = patient criteria (quoted +1 or 0) sum / evaluated criteria total sum

  1 day

Study Arms (1)

Patients with ADS-MR

OTHER

Patients presenting Autism Spectrum Disorder and mental retardation who are evaluated for their ADS severity, their adaptative and intellectual functioning, psychiatric and somatic comorbidities

Other: ADS severity; Other: Adaptative and intellectual functioning; Other: Psychiatric and somatic comorbidities

Interventions

ADS severity OTHER

Evaluation of the ADS severity with the CARS scale

Patients with ADS-MR

Adaptative and intellectual functioning OTHER

Evaluation with IQ and Vineland II scale

Patients with ADS-MR

Psychiatric and somatic comorbidities OTHER

Evaluation with the Reiss, DSQIID and CIRS Scales

Patients with ADS-MR

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ADS diagnosis using DSM-5 or CIM-10 criteria, associated to mental retardation
• Age over 20 years
• Patient living in Languedoc-Roussillon's medico-social care home
• Patient benefiting from social security
• Patient or legal representative consent collected

You may not qualify if:

• Patient or legal representative disagreement to participate at the sudy
• Pregnant woman or nursong mother
• Patient with Down syndrom

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Interventions

Psychiatry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Amaria BAGHDADLI, PU-PH

  CRA Peyre Plantade - La Colombière - CHU Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: September 23, 2016
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)