Plain English Summary
Background and study aims
Young people with chronic illness are up to nine times more likely to have mental health disorders than the general population. However, many children are not able to access Child and Adolescent Mental Health Services. This project builds on a previous research study at a paediatric hospital which increased access to evidence-based psychological treatment for children and young people with mental health needs. A drop-in mental health centre was set up in a paediatric hospital, which served as a single point of access for evidence-based low-intensity psychological interventions, signposting and onward referrals. There was a significant positive impact of attending the drop-in centre on symptoms and quality of life for children, parents, and siblings. The next stage of this study aims to evaluate the national roll-out of drop-in mental health centres and services in paediatric hospitals across the UK.
Who can participate?
Patients aged 5-25 years old, and families of patients at participating hospitals who have been receiving care for 6 months or more
What does the study involve?
The study involves an assessment call with a practitioner to assess mental health and wellbeing needs. Depending on clinical need, young people and their families will either receive a low-intensity psychological intervention, a referral to other services in their hospital or signposting to other services or resources. Families are asked to complete standardised questionnaires at baseline and at 6-month follow-up.
What are the possible benefits and risks of participating?
The project aims to benefit families' mental health and improve access to mental health support. We do not foresee any risks in taking part but answering some of the baseline and follow-up questionnaires may cause some emotional distress.
Where is the study run from?
The study is run by UCL Great Ormond Street Institute of Child Health (UK) and open at multiple paediatric hospitals and services across the UK
When is the study starting and how long is it expected to run for?
October 2021 to December 2024
Who is funding the study?
1. Beryl Alexander Charity (UK)
2. Great Ormond Street Hospital Children’s Charity (UK)
Who is the main contact?
Anna Roach, anna.roach.21@ucl.ac.uk (UK)
Study website
Contact information
Type
Principal Investigator
Contact name
Prof Roz Shafran
ORCID ID
Contact details
30 Guildford Street
London
WC1N 1EH
United Kingdom
+44 (0)7596890672
r.shafran@ucl.ac.uk
Type
Public
Contact name
Miss Anna Roach
ORCID ID
Contact details
30 Guildford Street
London
WC1N 1EH
United Kingdom
+44 (0)7596890672
anna.roach.21@ucl.ac.uk
Type
Scientific
Contact name
Miss Anna Roach
ORCID ID
Contact details
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)7596890672
anna.roach.21@ucl.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
213733
ClinicalTrials.gov number
Nil known
Secondary identifying numbers
16HN11, IRAS 213733, CPMS 52414
Study information
Scientific title
Clinical effectiveness of drop-in mental health services at paediatric hospitals: A non-randomised multi-site study
Acronym
Study hypothesis
A mental health and wellbeing drop-in service delivering low-intensity psychological interventions at paediatric hospitals improve emotional and behavioural outcomes for children and parents.
Ethics approval(s)
Approved 14/12/2016, London – Riverside (Meeting held by video conference via Zoom; +44 (0)207 104 8150, (0)207 104 8013; riverside.rec@hra.nhs.uk), ref: 16/LO/1915
Study design
Multicentre interventional non-randomized controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Mental health support for families of children with chronic conditions
Intervention
This is a single-arm trial with no control group.
Referral methods:
Participants will be referred using different pathways depending on which hospital they attend. They can self-refer to the project, using a QR code or email address which is available on study posters. Alternatively, they can be referred by their clinician, who, after gaining families’ consent to contact, can share their details with the study team, who will get in touch with more information and details for the next steps and consent process.
Observations for all groups:
All participants will fill out baseline measures after consenting to be part of the study. Baseline measures include demographic information, the Strengths and Difficulties Questionnaire, the Pediatric Quality of Life Questionnaire, and for those aged 12 years old and above the Patient Health Questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7). Following this, all families will have an assessment call with a trained low-intensity therapist to allocate them to the most appropriate treatment. For those for which it is clinically appropriate, low-intensity cognitive behavioural therapy (CBT) interventions, such as guided self-help, will be delivered to families as 30-minute sessions over 4/6 weeks. For families with concerns that can not be appropriately treated with CBT (either mental health needs are too severe, or they have a specific need best addressed elsewhere), they will be referred to other services, such as CAMHS or can be signposted to specific support services.
Follow-up for all groups:
All participants will complete follow-up questionnaires, 6 months after completing their baseline questionnaires. Questionnaires will include the Strengths and Difficulties Questionnaire, the Pediatric Quality of Life Questionnaire, and for those aged 12 years old and above the PHQ9 and GAD7. At follow-up, all participants will also be asked to complete the Centre Satisfaction Questionnaire.
Intervention type
Behavioural
Primary outcome measure
Parent-reported emotional and behavioural problems measured using the total score on the Strengths and Difficulties Questionnaire (SDQ) at baseline and 6 month follow-up
Secondary outcome measures
1. Parent-reported quality of life measured using the Paediatric Quality of Life (PedsQL) total score at baseline and 6 month follow up
2. Child-reported emotional and behavioural problems measured using the total score on the SDQ at baseline and 6 month follow up
3. Child-reported quality of life measured using the PedsQL total score at baseline and 6 month follow up
4. Child-reported low mood measured using the Patient Health Questionnaire-9 (PHQ-9) total score at baseline and 6 months
5. Parent-reported low mood measured using the PHQ9 total score at baseline and 6 months
6. Child-reported anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) total score at baseline and 6 months
7. Parent-reported anxiety measured using the GAD7 total score at baseline and 6 months
Overall study start date
04/10/2021
Overall study end date
31/12/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Aged between 5-25 years old and has been a patient at a participating paediatric hospital within the last 6 months or be a carer/family member/sibling of such patients
Participant type(s)
Mixed
Age group
Mixed
Lower age limit
5 Years
Upper age limit
25 Years
Sex
Both
Target number of participants
180 (30 per site)
Total final enrolment
120
Participant exclusion criteria
Participants must not have been currently under the care of psychology services within their hospital
Recruitment start date
16/11/2022
Recruitment end date
04/01/2024
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Cambridge and Peterborough NHS Foundation Trust
Elizabeth House
Fulbourn Hospital
Cambridge Road
Cambridge
CB21 5EF
United Kingdom
Study participating centre
University College London Hospitals NHS Foundation Trust Hq
250 Euston Road
London
NW1 2PG
United Kingdom
Study participating centre
Hinchingbrooke Hospital (hinchingbrooke Healthcare Trust)
Hinchingbrooke Park
Huntingdon
PE29 6NT
United Kingdom
Study participating centre
Sheffield Childrens Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
Study participating centre
Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study participating centre
Peterborough City Hospital
Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Sponsor information
Organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor details
Great Ormond Street
London
WC1N 3JH
England
United Kingdom
+44 (0)20 7405 9200
research.governance@gosh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Charity
Funder name
Great Ormond Street Hospital Charity
Alternative name(s)
Great Ormond Street Hospital Children's Charity, GOSH Charity, GOSH
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
Beryl Alexander Charity
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
Intention to publish date
01/08/2025
Individual participant data (IPD) Intention to share
No
IPD sharing plan
The data-sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 09/05/2024 | 10/05/2024 | Yes | No |