Condition category
Mental and Behavioural Disorders
Date applied
03/06/2019
Date assigned
10/06/2019
Last edited
14/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Problems with Social Communication (PSC), including Autism Spectrum Disorders (ASD’s), are lifelong and associated with difficulties in social interaction, communication and restricted, repetitive behaviours. Most research has focused on these issues in childhood. Little is known about how common ASD’s and other PSC are among adults, including those admitted to psychiatric hospitals.
Identifying people with ASD’s and other PSC will enable them to access services appropriate for their needs that can improve their quality of life. There is a risk that these people are otherwise incorrectly diagnosed with other mental disorders, and offered treatments unlikely to be helpful for them. Nevertheless, some people have both PSC or ASD and other mental and physical health conditions (comorbidities), though the extent of this problem is poorly understood.
This study aims to:
(1) Estimate how common ASD’s are amongst adults who have been admitted to psychiatric hospitals
(2) Examine the association between other mental and physical health conditions in this population.

Who can participate?
Anyone aged over 18 who is or has been a psychiatric inpatient on an acute mental health ward

What does the study involve?
We will collect data on patient’s social communication, quality of life and physical and mental health (Phase 1). A subgroup of patients, selected via stratified random sampling according to Autism Quotient score, will be invited into Phase 2, involving comprehensive autism diagnostic criteria testing.
Patients with intellectual disabilities will bypass Phase 1 tests, progressing directly to Phase 2.
All Phase 2 patients will also be given a standardized interview regarding their physical and mental health. Following the Phase 2 interview, checklists for internationally recognised diagnostic criteria for autism will be completed by the assessing member of the research team, to establish whether the patient satisfies such criteria.

What are the possible benefits and risks of participating?
Individuals who participate in this study cannot be assured that they will directly benefit from the research themselves. However, the findings of this study will add to the currently limited evidence base in terms of the prevalence of autism among adults admitted to psychiatric hospitals, and the healthcare needs of this group.
In terms of risks, the study does not involve any invasive tests, such as blood testing. However, whilst most people enjoy completing the questionnaires and taking part in the interviews, some people can find certain questions potentially upsetting.

Where is the study run from?
Leicestershire Partnership NHS Trust, UK

When is the study starting and how long is it expected to run for?
March 2019 to December 2020

Who is funding the study?
National Institute for Health Research (NIHR), UK

Who is the main contact?
Dr Samuel J Tromans,
sjt56@leicester.ac.uk

Trial website

http://www.forensiclearningdisability.com

Contact information

Type

Scientific

Primary contact

Dr Samuel J Tromans

ORCID ID

http://orcid.org/0000-0002-0783-285X

Contact details

Leicestershire Partnership NHS Trust
Agnes Unit
400 Anstey Lane
Leicester
LE7 7GL
United Kingdom
01162955098
Sjt56@leicester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40960

Study information

Scientific title

The Prevalence of Social Communication PRoblems in Adult Psychiatric INpaTients: the SPRINT study

Acronym

The SPRINT Study

Study hypothesis

The research aims to estimate the prevalence of Autism Spectrum Disorders (ASD's) amongst adults who have been admitted to psychiatric hospitals (including those with intellectual disabilities) and examine the association between other mental and physical health conditions in adults who meet diagnostic criteria for ASDs with those who do not meet such criteria (all of whom have been admitted to a psychiatric hospital) and other psychiatric and physical comorbidities within an adult psychiatric inpatient population.

Ethics approval

Approved 22/02/2019, (East of England – Essex Research Ethics Committee, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; nrescommitteee.eastofengland-essex@nhs.net; 0207 104 8115), ref: 19/EE/0009.

Study design

Observational; Design type: Cross-sectional

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychiatric disorder requiring hospitalisation

Intervention

Adult patients (over 18 years of age) who have spent time on an acute mental health ward in a psychiatric hospital in Leicester will be invited to participate in the study.
Phase 1 of the study will involve completion of questionnaire tests, including the Autism Quotient (AQ), the Adult Social Behaviour Questionnaire, (ASBQ, which will be completed by both the patient as well as an informant who knows them well, such as a close relative or long-term partner), EuroQol-5D-5L (EQ-5D-5L, completed by both participant and informant) and the informant version of the Social Responsiveness Scale, 2nd edition Adult (SRS-2). They will complete these questionnaires independently, and either post them back to the research team or make them available for a member of the research team to collect (if they are still in hospital). Patients with intellectual disabilities will not undertake the Phase 1 questionnaire tests and they will instead progress directly to Phase 2. Further information regarding all patients will be collected from them directly, using a standardised form designed by the research team. The information collected will include the following:
Basic information:
1. Date of birth
2. Sex
3. Postcode
4. Ethnic group
5. Employment status
6. Relationship status
Mental health (psychiatric) history:
7. Date of most recent psychiatric hospital admission
8. Discharge date of most recent psychiatric hospital admission (where applicable)
9. Total number of inpatient psychiatric admissions
10. Mental health diagnoses (ICD-10)
Physical Health (Medical History):
11. Physical health diagnoses (ICD-10)

A sample of patients without intellectual disabilities (selected according to their AQ test score) and all patients with intellectual disabilities, will be invited into Phase 2 of the study, involving further comprehensive autism diagnostic testing, including the diagnostic algorithm and forensic items for the Diagnostic Interview for Social and Communication Disorders (DISCO-A), which will be undertaken with an informant for the patient, as well as the Autism Diagnostic Observation Schedule (ADOS-2), the Autism Spectrum Disorder interview within the Schedules for Clinical Assessment in Neuropsychiatry version 3 (ASD-SCAN-3). Patients with intellectual disabilities will not undergo ASDSCAN-3 testing, and will instead be tested with the Stigma Questionnaire for people with Intellectual Disability (SQID).
All patients will also be interviewed on the Physical Health Conditions and Mental Illness Diagnoses and Treatment sections of the 2014 Adult Psychiatric Morbidity Survey (APMS), in order to provide information about their mental and physical health needs.

Following the Phase 2 interview process, checklists for internationally recognised diagnostic criteria for ASD (the 10th revision of the International Statistical Classification of Diseases and Related Health Problems Diagnostic Criteria for Research [ICD-10-DCR] and the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders [DSM-5]) will be completed by the assessing member of the research team, to establish whether the patient satisfies such criteria.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The primary outcome measure for the study will be the absence or presence of meeting internationally agreed diagnostic criteria (ICD-10-DCR and DSM-5) for ASD. This will be after Phase 2 clinical assessments have been completed (i.e. Diagnostic Interview for Social and Communication Disorders, Autism Diagnostic Observation Schedule and the Autism questions for the Schedules for Clinical Assessment in Neuropsychiatry version 3), at which point the assessing member of the research team will establish whether the participant meets the diagnostic criteria through the use of ICD-10-DCR and DSM-5 diagnostic criteria checklists.

Secondary outcome measures

Extent of other mental and physical health conditions in adults in who meet diagnostic criteria for autism, compared with those who do not meet such criteria (this information will be obtained from data obtained on the standardized Phase 2 interviews regarding physical and mental comorbidity).

Overall trial start date

02/05/2017

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 to 65 years of age (on the date of psychiatric hospital admission)
2. Being or having been a psychiatric inpatient on an acute mental health ward
3. Understand written and/or verbal English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Clinical diagnosis of dementia
2. Patients lacking capacity will be excluded if they become distressed by the assessment process (at any point) or if their guardians are not in agreement with them remaining in the study.

Recruitment start date

06/03/2019

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
Riverside House Bridge Park Plaza Bridge Park Road Thurmaston
Leicester
LE4 8PQ
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Academic Department (Ground Floor)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
01162584099
uolsponsor@le.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/06/2019: Uploaded protocol (not peer-reviewed). 05/06/2019: Trial’s existence confirmed by NIHR.