Evaluating mental health and psychological wellbeing drop-in services at paediatric hospitals
| ISRCTN | ISRCTN15063954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15063954 |
| IRAS number | 213733 |
| Secondary identifying numbers | 16HN11, IRAS 213733, CPMS 52414 |
- Submission date
- 22/11/2022
- Registration date
- 09/12/2022
- Last edited
- 16/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 June 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@annafreud.org
Contact information
Principal Investigator
30 Guildford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)7596890672 |
|---|---|
| r.shafran@ucl.ac.uk |
Public, Scientific
30 Guildford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)7596890672 |
|---|---|
| anna.roach@annafreud.org |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Clinical effectiveness of drop-in mental health services at paediatric hospitals: A non-randomised multi-site study |
| 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 |
| 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 | 30/06/2024 |
Eligibility
| 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 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 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 centres
Fulbourn Hospital
Cambridge Road
Cambridge
CB21 5EF
United Kingdom
London
NW1 2PG
United Kingdom
Huntingdon
PE29 6NT
United Kingdom
Sheffield
S10 2TH
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Sponsor information
Hospital/treatment centre
Great Ormond Street
London
WC1N 3JH
England
United Kingdom
| Phone | +44 (0)20 7405 9200 |
|---|---|
| research.governance@gosh.nhs.uk | |
| Website | http://www.gosh.nhs.uk/ |
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Great Ormond Street Hospital Children's Charity, GOSH Charity, GOSH
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data will be made available upon request by a bona fide research team. Contact person: Anna Roach anna.roach@annafreud.org |
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 | |
| Results article | 14/04/2025 | 16/04/2025 | Yes | No |
Editorial Notes
16/04/2025: Publication reference added.
12/02/2025: A contact email was changed.
13/12/2024: The overall study end date was updated from 31/12/2024 to 30/06/2024. IPD sharing plan added.
10/05/2024: Publication reference added.
12/02/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 24/12/2024 to 04/01/2024.
3. The study participating centre Warrington and Halton Teaching Hospitals NHS Foundation Trust was removed and Peterborough City Hospital was added.
16/01/2023: Internal review.
