Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03120338 |
| Other study ID # |
17/NS/0002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
August 31, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
University of Aberdeen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The European Union is funding this randomised trial in Scotland as part of the larger eCAP
project (http://www.interreg-npa.eu/projects/funded-projects/project/139/). The need for
psychiatric services for children and adolescents is usually greater than the services
available. As well as this, in many cases, there is confusion as to which service the child
or young person should be referred to. The way children and young people arrive at Child and
Adolescent Mental Health Services (CAMHS) may therefore be relatively inefficient and
families could suffer as a result of this inefficiency.
The use of a computerised structured questionnaire such as the Development and Well-being
Assessment (DAWBA) offers the opportunity for these difficulties to be addressed, for the
avoidance of 'inappropriate referrals' and for more rational use of resources. It is usually
administered online through a secure internet portal. At the end of the data collection, a
computerised summary is generated from the data given by all the informants and a
child/adolescent psychiatrist lists the likely diagnosis or diagnoses in a summary of the
case and gives his view about the next steps. This is then made available to the referrer.
This community-based study aims to establish whether using the DAWBA in this way helps
children and young people with mental health problems. The main objectives are to improve
their mental health, reduce waiting times, change referral practice, increase satisfaction in
services and improve cost effectiveness. The principal outcome measure will be parent-rated
Strengths and Difficulties Questionnaire (SDQ) score 6 months after randomisation. Secondary
outcome measures will include teacher and child-rated SDQ at 6 months and waiting times to
services. The investigators will also record service use data and family out -of -pocket
costs. A random sample of young people, family and referrers will be interviewed to explore
satisfaction with service.
Description:
This project will involve 246 participants in each centre (123 intervention, 123 control).
Assuming 20% loss to follow-up (i.e. 197 completing) this will give 80% power at 5%
significance to detect a moderate effect size of 0.4 in each participating centre. If the
investigators assume that the typical SDQ Total Difficulties Score six months after referral
is 15 points (the boundary between 'borderline' and 'abnormal' scores), then this would
correspond to a difference between the groups of around 2 points which is probably near the
lower limit of clinically significant change.
Patient / parent name and telephone number will be supplied to the National Health Service
(NHS) Highland research nurse after verbal agreement is given to the referring practitioner
that the parent is happy to be contacted to gain formal consent to participate in the
project. These details (name and telephone number) will be supplied to enable the research
nurse to initially make contact with each participant.
The research nurse will then telephone the parent (contact will be made with the parent first
or the young person if aged 16 or over and either the young person or their parent is
unwilling for their parent to participate). If the parent agrees, the participant information
sheet and consent form will be emailed or posted to the family. Informed consent to
participation in the study will be obtained from parents or legal guardians and young people
aged 16 & 17, and young people aged 11 to 15 years will be asked for assent. Consent/assent
will be requested to cover:
- Participation in the project;
- Completion of simple questionnaires at baseline and six months;
- Provision of relevant contact details (parents, teachers, young people);
- allowing requests for qualitative interviews;
- giving researchers access to service use data. The consent form will explain that the
project is designed to find out whether doing a detailed mental health assessment before
specialist involvement improves the speed and efficiency of service delivery for
families (see attached information sheets).
On receipt of the completed consent forms in the post, the NHS research nurse will assign a
study number to the family and will contact the university statistics department (in
Aberdeen) by email for group allocation. Participants will be assigned at random either to
have a DAWBA administered (by parents in every case, by teachers when possible and by young
people aged 11 or over) plus usual care, or to receive usual care only.
If admitted into the project, participants' health records will be accessed by members of
research team only to establish levels of service use before and following intervention.
These data will be recorded as the number of contacts with a particular service e.g. General
Practitioner (GP), school nurse, health visitor, Primary mental Health Worker (PMHW), social
worker. No other details will be recorded.
All participants will then be asked to complete baseline measures including the Strengths and
Difficulties Questionnaire (SDQ) and demographic (age, sex, family structure, socio-economic
status, rurality/urban/city, and service use details. The investigators will ask for full
postcodes to allow for Scottish Index of Multiple Deprivation (SIMD) rank to be ascertained.
These baseline data will only be available to the study team (ideally collected via a secure
web portal), and will not be seen by the local clinicians.
The DAWBA will be administered online whenever possible, but in cases where there are
literacy problems or lack of internet connectivity, administration will be by telephone (the
interview being conducted by one of the NHS research nurses). In the case of online
completion, the NHS research nurse will pass on login details to parents, and ask them to
pass these on to teachers and young people (where relevant). If the parents are not willing
the NHS research nurse will do this. If the potential participant does not want information
sent to anybody else, then the information will not be sent. The potential participant's
wishes will be respected.
Once all assessments are completed, the NHS research nurse will alert the local DAWBA rater.
DAWBA ratings will be done by a local psychiatrist familiar with diagnostic classification
and local services. In exceptional circumstances (e.g., no psychiatrist available due to
illness) the Chief Investigator (Phil Wilson) is authorised to rate DAWBAs. (As the online
system is anonymised, this will not jeopardise his blindness to randomisation.) The
summarised DAWBA data and the full report will be shared with the referring clinician. The
referrer will make their own decision about how to handle communication about the DAWBA data
with families, referrers and specialist services. Other data, including the SDQ, will be held
securely and kept confidential by the research team as below.
Any data collected will be treated confidentially and will be reported anonymously. Any data
collected will be adequate, relevant and not excessive to the purpose of the research study
proposed.
All data will be retained according to the University of Aberdeen's retention policy.
The NHS Highland General Practitioners have full access to patient records as a matter of
routine, the research nurses will have access to patient / parent or teacher name / telephone
number. These NHS staff are familiar with handling data and operate under the umbrella of
confidentiality legislation within the NHS.
Participant consent will be sought for the research team to have access to:
GP records, school nurse records, PMHW records, Health Visitor (in case of very young
children) - to identify the number of times the participant has seen the referring
professional or other mental health service providers during the six months post recruitment.
Normal clinical confidentiality will apply, specifically information will be stored in a
locked filing cabinet or a password protected area of a shared drive within the University of
Aberdeen network. Only direct members of the research team will have access to participant
information and participants will be allocated a unique study number that does not contain
identifiable information. Identifiable information will be stored separately from study
information. Any identifiable data will be destroyed less than three months after the study
has ended. All other data will be stored securely for 10 years. The Chief Investigator will
act as custodian for all data. No personal identifiable information will be held on laptop
computers.
All data will be archived at the University of Aberdeen according to University of Aberdeen
policy.
Most data will be held within the secure server network of the University of Aberdeen. It is
impossible to access server drives without a valid staff username and password, and all files
will be held within a password protected area accessible only to members of the study team.
Any paper based data (such as a contact list for participants) will be held in a locked
filing cabinet at the Centre for Rural Health (University of Aberdeen) Data from the
telephone interviews (undertaken by the study research nurse) will be stored centrally on a
university held computer in accordance with University of Aberdeen data storage governance
policies.
Data will be gathered in accordance to the terms of the Data Protection Act (1988).
Personal identifiers will not be stored with research data. Unique identification numbers
will be used on separate contact information and research data files, which will be stored in
separate, secure locations on the University of Aberdeen servers. The investigators will
follow Data Protection Act and Caldicott guidelines in relation to use of patient information
at all times.
Participants will complete the DAWBA online. To maximise confidentiality and keep potentially
sensitive information safe, the DAWBA online system is anonymised - only the research group
knows which child has which identifier. Additional security is provided by using a secure
server with encryption.
Appropriate Child Protection training for the research nurses will be provided by NHS
Highland, it will be a group session for everyone involved in the project. NHS Highland will
keep the records of who has undertaken the training. There is also an independent contact for
potential participants to go to throughout the study.
