Condition category
Mental and Behavioural Disorders
Date applied
03/05/2019
Date assigned
29/05/2019
Last edited
12/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This research focuses on children with emotional difficulties who have been referred to Child and Adolescent Mental Health Services (CAMHS). Referrals are sometimes turned down by CAMHS, often because of insufficient information. Even if the referral is accepted, assessments are often carried out without reaching a clinical diagnosis. This is important because receiving the correct diagnosis is vital so that appropriate help can be offered. We want to find out whether the use of a standard information-gathering package helps with the assessment and diagnosis process in CAMHS. Children referred to CAMHS will be randomly selected to go into one of two groups. Either the referral will be looked at as usual, or the package will be tested. This involves information being collected from the parent (and the child, if aged 11+) soon after the referral is received but before any decision has been made about accepting the referral. This information will then be passed on to the CAMHS clinicians and the family. We will assess how effective and cost-effective this approach is by seeing whether it makes any difference to whether or not a diagnosis is made and whether this better helps children and their families. We will follow the children up for 12 months to assess the impact on their emotional difficulties, day-to-day functioning and quality of life. For children and their families, receiving the right help at the right time can make a huge difference to their lives. By evaluating different approaches to assessment within CAMHS, and publicising our findings, our research will help improve care and inform clinical guidelines. Our findings will help the NHS decide how best to ensure value for money for how emotional difficulties are diagnosed.

Who can participate?
Children and young people (age 5-17 years) presenting with emotional difficulties referred to Child and Adolescent Mental Health Services (CAMHS), as well as their parents/carers.

What does the study involve?
Participants are randomly allocated to one of two groups. One group will be asked to complete an online package of questionnaires called the Development and Well-Being Assessment tool (DAWBA) in addition to the usual referral process. This will be completed after participants have been referred to CAMHS- but before a referral decision has been made. A summary report will be provided to both participants and clinical staff. The other group will receive usual care only, i.e. the referral will be reviewed based on the usual information provided to clinicians. All participants, regardless of group, will be asked to complete some online questionnaires 6 months and 12 months after joining the study.

What are the possible benefits and risks of participating?
Young people aged 11 and over, as well as all participating parents or carers, will receive a £20 voucher (upon receipt of the 12-month follow up questionnaire) as a thank you for the additional time spent on involvement in the research. By taking part in this study, there are no additional risks beyond undergoing usual referral and treatment to CAMHS. Participants may experience some worry or distress due to some of the questions asked in the questionnaires, but this is expected to be a similar experience to usual practise.

Where is the study run from?
The STADIA Trial is being run by the University of Nottingham, and takes place in a number of participating CAMHS in England.

When is the study starting and how long is it expected to run for?
June 2019 to April 2022

Who is funding the study?
The National Institute for Health Research, UK.

Who is the main contact?
Florence Day,
stadia@nottingham.ac.uk

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/169609/

Contact information

Type

Public

Primary contact

Mrs Florence Day

ORCID ID

Contact details

Nottingham Clinical Trials Unit
Building 42
Room B03
University Park
Nottingham
NG7 2RD
United Kingdom
01158231588
stadia@nottingham.ac.uk

Type

Scientific

Additional contact

Prof Kapil Sayal

ORCID ID

http://orcid.org/0000-0002-2050-4316

Contact details

Institute of Mental Health
University of Nottingham Jubilee Campus
Triumph Road
Nottingham
NG7 2TU
United Kingdom
01158230264
kapil.sayal@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41507

Study information

Scientific title

STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA): a multi-centre randomised controlled trial

Acronym

STADIA

Study hypothesis

The study aims to find out whether the use of a standardised diagnostic assessment (SDA) tool improves the detection and treatment outcomes of emotional disorders in young people referred to CAMHS.

Ethics approval

Approved 12/06/2019, West Midlands - South Birmingham Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0207 1048101; nrescommittee.westmidlands-southbirmingham@nhs.net), ref: 19/WM/0133

Study design

Randomised; Both; Design type: Diagnosis, Process of Care, Management of Care, Other, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Intervention

This research focuses on children with emotional difficulties who have been referred to Child and Adolescent Mental Health Services (CAMHS). Referrals are sometimes turned down by CAMHS, often because of insufficient information. Even if the referral is accepted, assessments are often carried out without reaching a clinical diagnosis. This is important because receiving the correct diagnosis is vital so that appropriate help can be offered.

We want to find out whether the use of a standard information-gathering package helps with the assessment and diagnosis process in CAMHS. Children referred to CAMHS will be randomly selected to go into one of two groups. Either the referral will be looked at as usual, or the package will be tested. This involves information being collected from the parent (and the child, if aged 11+) soon after the referral is received but before any decision has been made about accepting the referral. This information will then be passed on to the CAMHS clinicians and the family.

We will assess how effective and cost-effective this approach is by seeing whether it makes any difference to whether or not a diagnosis is made and whether this better helps children and their families. We will follow the children up for 12 months to assess the impact on their emotional difficulties, day-to-day functioning and quality of life.

For children and their families, receiving the right help at the right time can make a huge difference to their lives. By evaluating different approaches to assessment within CAMHS, and publicising our findings, our research will help improve care and inform clinical guidelines. Our findings will help the NHS decide how best to ensure value for money for how emotional difficulties are diagnosed.

The study aims to find out whether the use of a standardised diagnostic assessment (SDA) tool improves the detection and treatment outcomes of emotional disorders in young people referred to CAMHS. SDA tools are structured assessments that indicate the presence of difficulties according to established diagnostic criteria. There are several valid and reliable SDA tools, however, there is uncertainty over the value of these in clinical practice and they are not routinely used. Because there is uncertainty a randomised controlled trial is the appropriate methodology. The SDA tool will be tested as an addition to usual practice and this will be compared with current usual practice only.

The SDA tool to be tested in the current study is the Development and Well-Being Assessment (DAWBA). The DAWBA has been widely used and has established reliability and validity.

Participants will be recruited through CAMHS services (including triage/single point of access [SPA] teams) in the participating NHS sites and identified at the point of referral receipt. Participants will be randomised to the DAWBA in addition to usual practice, or usual practice only. Those allocated to complete the DAWBA will be provided with a link to the online system and will be offered additional telephone support to complete the online questionnaire if required. Following completion, the results of the DAWBA will be provided to the participant and to the CAMHS team considering the referral. A copy will be saved in the young person’s CAMHS record.

Data collection from participants will be completed online, and supplemented by collection of data from CAMHS records. Participants will be followed up for 12 months, with data collection at 6 and 12 months post-randomisation. A subset of participants will also be invited to take part in qualitative interviews.

Alongside this, qualitative interviews will also be carried out with clinicians, service managers and commissioners.

This is a 4-year study, which started in November 2018. Recruitment of participants is due to commence in June 2019 and will continue for up to 2 years. There is a 12 month follow-up period, followed by 6 months for analysis and reporting.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Clinician-made diagnosis decision about the presence of an emotional disorder within 12 months of randomisation. Diagnosis of an emotional disorder will be coded as ‘yes’; absence or uncertainty (for example, reflecting ongoing assessment / investigation) about the presence of an emotional disorder will be coded as ‘no’.

Secondary outcome measures

1. Acceptance of index referral – measured as: accepted by CAMHS = yes vs. declined by CAMHS= no; collected within 12 months of randomisation
2. Acceptance of any referral within 12 months of randomisation – measured as: any referral accepted by CAMHS = yes vs. no referrals accepted by CAMHS= no; collected within 12 months of randomisation
3. Confirmed diagnosis decision – measured as: diagnosis of an emotional disorder or confirmed absence of an emotional disorder coded as ‘yes’ vs. uncertainty about the presence of an emotional disorder coded as ‘no’; collected within 12 months of randomisation
4. Time from randomisation to diagnosis of emotional disorder – measured as: the time (in days) as derived from the randomisation date and date of diagnosis; collected within 12 months of randomisation
5. Diagnoses made over the 12 month period from randomisation – measured using: standard proforma (pre-specified diagnoses); collected within 12 months of randomisation
6. Treatment offered for diagnosed emotional disorder – measured as: documented diagnosis of an emotional disorder AND documented treatment offered = yes vs. no documented diagnosis of emotional disorder and/or no documented treatments offered = no; collected within 12 months of randomisation
7. Treatments / interventions given – measured as: Pre-specified treatments will be captured using a standard proforma; collected within 12 months of randomisation
8. Time from randomisation to start of first treatment – measured as: the time (in days) from randomisation to start of first treatment as derived from the randomisation date and documented start date of first treatment; collected within 12 months of randomisation
9. Participant-reported diagnoses received in the 12 months post-randomisation – collected at 6 and 12 months post-randomisation
10. Depression symptoms ( child/young person) – measured using the Mood and Feelings Questionnaire (MFQ) at Baseline, 6 and 12 months post-randomisation
11. Anxiety symptoms (child/young person) – measured using the Revised Children’s Anxiety and Depression Scale (RCADS) at Baseline, 6 and 12 months post-randomisation
12. Oppositional defiant / conduct disorder symptoms (child/young person) – measured using the Strengths & Difficulties Questionnaire (SDQ) at Baseline, 6 and 12 months post-randomisation
13. Functional Impairment (child/young person) – measured using the Strengths & Difficulties Questionnaire (SDQ) at Baseline, 6 and 12 months post-randomisation
14. Self-harm (child/young person) – measured via self-report at Baseline, 6 and 12 months post-randomisation
15. Depression symptoms (parent/carer) – measured using the PHQ-9 questionnaire at Baseline, 6 and 12 months post-randomisation
16. Anxiety symptoms -(parent/carer) – measured using the GAD-7 questionnaire at Baseline, 6 and 12 months post-randomisation
17. Health related quality of life – Child/young person QoL measured using the Child Health Utility 9D (CHU9D) questionnaire and the EuroQol Quality of Life Questionnaire 5 Domains for Young People (EQ5DY) at Baseline, 6 and 12 months post-randomisation. Parent/carer QoL measured using the EuroQol Quality of Life Questionnaire 5 Domains, 5 Levels (EQ5D5L) at Baseline, 6 and 12 months post-randomisation
18. Time off education, employment or training because of emotional difficulties for the child/young person – measured as the days missed from education, employment or training (as applicable) for the child/young person due to emotional difficulties; collected at Baseline, 6 and 12 months post-randomisation

Overall trial start date

01/11/2018

Overall trial end date

30/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria for the child/young person:
1. Aged 5 to 17 years.
2. Referred to outpatient multidisciplinary specialist CAMHS.
3. Presenting with emotional difficulties.
4. If aged <16, has an eligible individual with parental responsibility (the parent/carer - see eligibility criteria below) willing and able to participate in the trial.
5. If aged 16-17, has capacity to provide valid written informed consent.
6. If aged 16-17 and participating without a parent/carer, able to complete the assessment tool in English.
7. If aged 16-17 and participating without a parent/carer, access to internet and email or telephone.

Inclusion criteria for the parent/carer:
1. Individual with parental responsibility for the child/young person referred to CAMHS.
2. Adequate knowledge of the child/young person to be able to complete the assessment tool (i.e., known for at least 6 months).
3. Has capacity to provide valid written informed consent.
4. Access to internet and email or telephone.
5. Able to complete the assessment tool in English.

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 1210; UK Sample Size: 1210

Participant exclusion criteria

Exclusion criteria for the child/young person:
1. Emergency or urgent referral to outpatient multidisciplinary specialist CAMHS (i.e. requires an expedited assessment) according to local risk assessment procedures.
2. Child has severe learning disability.
3. Previously randomised in the STADIA trial.

Exclusion criteria for the parent/carer:
1. Local authority representatives designated to care for the child/young person.

Recruitment start date

14/06/2019

Recruitment end date

30/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Foundation Trust
The Resource, Trust HQ Duncan Macmillan House Porchester Road
Nottingham
NG3 6AA
United Kingdom

Trial participating centre

Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital Cambridge
Cambridgeshire
CB21 5EF
United Kingdom

Trial participating centre

Central And North West London NHS Foundation Trust
Stephenson House 75 Hampstead Road
London
NW1 2PL
United Kingdom

Trial participating centre

Pennine Care NHS Foundation Trust
225 Old Street
Ashton-under-lyne
OL6 7SR
United Kingdom

Sponsor information

Organisation

Nottinghamshire Healthcare NHS Foundation Trust

Sponsor details

The Resource
Trust HQ
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom
0115 969 1300
RandIenquiries@nottshc.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/96/09

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 datasets generated during and/or analysed during the current study will be available upon request from Nottingham Clinical Trials Unit (ctu@nottingham.ac.uk). Anonymised, participant level data will be available following publication of the results by the trial team.

Intention to publish date

30/10/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/07/2019: The ethics approval was added. 31/05/2019: Internal review.