Autism Spectrum DisorderEFAARNCT02791321
Fragility Assessment in Adults With ADHD and Mental Retardation
A study testing ADS severity, Adaptative and intellectual functioning and Psychiatric and somatic comorbidities in people with Autism Spectrum Disorder and Mental Retardation, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Autism Spectrum Disorder, Mental Retardation
- What is being tested?
- ADS severity, Adaptative and intellectual functioning and Psychiatric and somatic comorbidities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2016to 16 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient or legal representative disagreement to participate at the sudy
- Pregnant woman or nursong mother
- Patient with Down syndrom
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age
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.
Read more
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.
Read the detailed description
Calendar :
This study will take place during 60 months. 4 first months will be devoted at the ethic and administrative issues. Inclusion will take place during 26 months. Follow-up will take 5 years. Last months will be used for data analysis and articles submission.
Perspectives :
This study will be the first describing frailty evolution during aging in patients suffering from ADS-MR. It will be useful for creating a new, simple and pragmatical frailty screening tool specific for ADS-MR patients in order to detect earlier which patient are the most frail.
- Conditions
- Autism Spectrum Disorder, Mental Retardation
- Being tested
- ADS severity, Adaptative and intellectual functioning, Psychiatric and somatic comorbidities
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADS severityOther
Evaluation of the ADS severity with the CARS scale
Adaptative and intellectual functioningOther
Evaluation with IQ and Vineland II scale
Psychiatric and somatic comorbiditiesOther
Evaluation with the Reiss, DSQIID and CIRS Scales
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ADS severity; Other: Adaptative and intellectual functioning; Other: Psychiatric and somatic comorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start23 Sep 2016
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaria BAGHDADLI, PU-PH, Principal investigator, CRA Peyre Plantade - La Colombière - CHU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791321
- Sponsor's protocol ID
- 9691
- Acronym
- EFAAR
- Status last verified
- Apr 2024
- First submitted
- 1 Jun 2016
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age
- ClinicalTrials.gov ID
- NCT02791321
- Acronym / sponsor ID
- EFAAR / 9691
- Conditions
- Autism Spectrum Disorder, Mental Retardation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Calendar :
This study will take place during 60 months. 4 first months will be devoted at the ethic and administrative issues. Inclusion will take place during 26 months. Follow-up will take 5 years. Last months will be used for data analysis and articles submission.
Perspectives :
This study will be the first describing frailty evolution during aging in patients suffering from ADS-MR. It will be useful for creating a new, simple and pragmatical frailty screening tool specific for ADS-MR patients in order to detect earlier which patient are the most frail.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ADS-MR | Other | Other: ADS severity, Other: Adaptative and intellectual functioning, Other: Psychiatric and somatic comorbiditiesPatients presenting Autism Spectrum Disorder and mental retardation who are evaluated for their ADS severity, their adaptative and intellectual functioning, psychiatric and somatic comorbidities |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient or legal representative disagreement to participate at the sudy
- Pregnant woman or nursong mother
- Patient with Down syndrom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADS severityEvaluation of the ADS severity with the CARS scale | Other | Patients with ADS-MR |
| Adaptative and intellectual functioningEvaluation with IQ and Vineland II scale | Other | Patients with ADS-MR |
| Psychiatric and somatic comorbiditiesEvaluation with the Reiss, DSQIID and CIRS Scales | Other | Patients with ADS-MR |
Primary outcome
Frailty index
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amaria BAGHDADLI, PU-PH principal investigator
CRA Peyre Plantade - La Colombière - CHU Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADS severity, Adaptative and intellectual functioning and Psychiatric and somatic comorbidities in people with Autism Spectrum Disorder and Mental Retardation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty index (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.