ISRCTN ISRCTN11789891
DOI https://doi.org/10.1186/ISRCTN11789891
Integrated Research Application System (IRAS) 341218
Central Portfolio Management System (CPMS) 61517
National Institute for Health and Care Research (NIHR) 207139
Sponsor Edge Hill University
Funder National Institute for Health and Care Research
Submission date
12/02/2026
Registration date
20/02/2026
Last edited
20/02/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
1 in 5 children and young people (CYP) need mental health support. Enhancing access to mental health services for those aged 0-17 years is a key NHS priority and yet many CYP are not receiving timely or appropriate help. Creative therapies are known to foster relationships and enhance the wellbeing of young people, but research with children and young people is sparse.
Arts for the Blues is a creative psychological therapy combining support for depression and anxiety with arts psychotherapies that has been developed by academics, clinicians and artists associated with Edge Hill University and the University of Salford. It is offered in 12 sessions, twice a week for 6 weeks, and includes creative methods such as movement, drawing, writing, as well as talking.
The aim of this study is to explore whether it is possible and acceptable to introduce Arts for the Blues for Children as an intervention into children and young people’s mental health services and to evaluate the impact for children and young people engaging with Arts for the Blues before a larger national study can take place.

Who can participate?
CYP aged 9-13 years who have been referred to or are currently receiving services from a children’s mental health services in the NHS.

What does the study involve?
Initially, the child or young person and their primary caregiver will meet the therapy / research team and complete some standardised questionnaires . CYP will then be randomly allocated to join either the Arts for the Blues group for creative sessions twice a week for 6 weeks in addition to usual support, or the group that continues usual support only. Participants (CYP and their primary caregivers) will be asked to answer questionnaires again after the 6 weeks along with a focus group for CYP. After 3 months, all participants will be asked to complete the same questionnaires for the final time.

What are the possible benefits and risks of participating?
There is clear evidence that creative arts therapies can improve children’s mental health and wellbeing. Children and young people are allocated to the intervention group will participate in 12 sessions of creative therapy to explore their mental health and wellbeing difficulties in a supportive and safe group environment. This experience is intended to be beneficial, providing an opportunity for CYP to voice their thoughts and feelings about the helpful and unhelpful aspects of the creative therapy. Comments from CYP will potentially help to improve mental health services and will contribute to shaping new treatment pathways for depression. 
Taking part in a creative, group psychotherapy will give CYP the opportunity to explore their experiences of mental health. A child or young person may find that exploring some difficult experiences can be potentially upsetting, which is not uncommon in therapy as difficult feelings can be stirred during these explorations. If a child or young person experiences any distress, the therapist or members from the research team will be able to discuss any support that the CYP and their caregiver may need from their NHS Foundation Trust or other community settings and will support them in being signposted to these if required. 

Where is the study run from?
The study will take place at the following NHS trusts: Mersey Care NHS Foundation Trust; Manchester University Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
The study began in October 2025, with recruitment of participants expected to being in Spring 2026. The study is expected to run to until the autumn of 2027.

Who is funding the study?
This study is funded by the National Institute for Health and Care Research (NIHR). Specifically, the funding relates to the Research for Patient Benefit (RfPB) programme.

Who is the main contact?
1. Prof. Vicky Karkou, Karkouv@edgehill.ac.uk
2. Dr Roshelle Ramkisson, Roshelle.Ramkisson2@mft.nhs.uk

Contact information

Prof Vicky Karkou
Public, Scientific, Principal investigator

Research Centre for Arts and Wellbeing
Edge Hill University
St Helens Road
Ormskirk
L39 4QP
United Kingdom

ORCiD logoORCID ID 0000-0001-8986-956X
Phone +44 (0)1695575171
Email Karkouv@edgehill.ac.uk

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentParallel
PurposeTreatment
Scientific titleABC-f: Arts for the Blues for Children and young people (9-13 year-olds) with symptoms of depression using mental health services: A feasibility study on an evidence-based creative group psychotherapy compared to treatment as usual
Study acronymABC-f
Study objectivesOverall aim:
To determine whether it is feasible to conduct a study with Children and Young People (CYP) aged 9-13 within Child and Young People’s Mental Health Services (CYPMHS) to evaluate the effectiveness of Arts for the Blues, a creative group psychotherapy that draws on best practice in both arts and talking therapies.

The study will address important uncertainties relating to the study design (recruitment, randomisation, outcome measures) and the intervention (acceptability and adherence) and will answer the following research questions.
Uncertainties relating to the study design:
1. How successful is the recruitment strategy adopted?
2. How successful is the randomisation of participants to the different arms?
3. How acceptable and sensitive are the outcome and cost measures used?
Uncertainties relating to the intervention:
4. How acceptable is the intervention to CYP and therapists within different CYPMHS?
5. How easy is it for therapists to follow the treatment protocol?

The objectives will be:
1. To prepare for the delivery of the intervention.
2. To deliver the intervention collecting data before, after and at three-months follow up.
3. To complete analysis and make decisions on progression to full randomised controlled trial (RCT).
Ethics approval(s)

Approved 05/12/2025, London – Chelsea Research Ethics Committee (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8197; chelsea.rec@hra.nhs.uk), ref: 25/LO/0828

Health condition(s) or problem(s) studiedChildren and young people's mental health, specifically, symptoms of depression and anxiety
InterventionIn this study, we will use the Arts for the Blues model as the intervention, a form of therapy that draws upon arts psychotherapy literature and practice. It also draws on evidence-based forms of psychotherapy for depression recommended by NICE and used in NHS Talking Therapies (CBT, counselling for depression, short-term psychodynamic psychotherapy). It was developed following guidance from the Medical Research Council on researching complex interventions, and began with a systematic review of helpful factors, workshops with the public, therapists and patients and creative experimentations in the studio. The model is structured but flexible, delivering a mixture of personalised and creative methods (music, dance movement, drama and visual arts). It began as an intervention for adults using NHS Talking Therapies services (what used to be called Improving Access to Psychological Services [IAPT]). Since then, the model has been adapted for CYP and specifically for CYP in CYPMHS. In this study, it will be offered over 12 group sessions which will cover key ingredients through creative means.

Treatment as usual (TAU) is the control group that will include participants waiting or eventually receiving treatment offered at NHS CYPMHS sites. Treatment may include but not be limited to individual CBT, Dialectical Behaviour Therapy (DBT), Eye Movement Desensitisation and Reprocessing (EMDR), Non-Violent Resistance (NVR), family therapy and psychoanalytic psychotherapy. Monitoring what is routinely offered (and when) will inform the choice of an appropriate active control group in the future, if a fully powered RCT is deemed feasible.

Assenting CYP will be randomised to either Arts for the Blues (intervention) plus TAU or TAU (control group) in a ratio of 1:1, using block randomisation with random variable block sizes, stratified by site and age group.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Child anxiety and depression measured using the Revised Child Anxiety and Depression Scale (RCADS-25) at pre-intervention, post-intervention, and 3-month follow up
  2. Child anxiety and depression measured using the Revised Child Anxiety and Depression Scale - Parents (RCADS-25-P) at pre-intervention, post-intervention, and 3-month follow up
  3. Mental Wellbeing measured using the World Health Organisation- Five Well-Being Index (WHO-5) at pre-intervention, post-intervention, and 3-month follow up
  4. Mental Wellbeing measured using the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at pre-intervention, post-intervention, and 3-month follow up
  5. Quality of life measured using EQ-5D-Y at pre-intervention, post-intervention, and 3-month follow up
  6. CYP’s perceptions of problems and goal attainment during therapy measured using the Child Outcome Rating Scale (CORS) at pre-intervention, post-intervention, and 3-month follow up
  7. Service use measured using the Client Service Receipt Inventory (CSRI) at pre-intervention, post-intervention, and 3-month follow up
  8. Health-related quality of life measured using Child Health Utility 9D (CHU9D) at pre-intervention, post-intervention, and 3-month follow up
  9. Therapeutic relationship in group work measured using the Child Group Session Rating Scale (CGSRS) at each intervention session
Key secondary outcome measure(s)
Completion date30/09/2027

Eligibility

Participant type(s)
Age groupChild
Lower age limit9 Years
Upper age limit13 Years
SexAll
Target sample size at registration60
Key inclusion criteria1. 9-13 years old
2. Symptoms of depression and anxiety
3. Interested and willing to take part in group work
4. Interested and willing to take part in the creative interventions
5. Sufficient English to participate in the group
Key exclusion criteria1. At risk of harming themselves or others (determined by the presence of suicidal intent and/or plan)
2. Comorbid MH problems (e.g., severe eating disorders, learning disabilities and/or autism as the main presentation). In these cases, a different approach to arts psychotherapies will be needed
3. Other (e.g., physical) difficulties that would make attending the group difficult
4. Currently receiving another creative therapy (e.g., dance movement, art, drama, music, play therapy or psychodrama) one to one or in a group, or having previously been part of any Arts for the Blues group
5. Currently receiving any other form of group intervention
6. Currently involved in another research study
Date of first enrolment01/04/2026
Date of final enrolment30/04/2027

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centres

Mersey Care NHS Foundation Trust
V7 Building
Kings Business Park
Kings Drive
Prescot
L34 1PJ
England
Manchester University NHS Foundation Trust
Cobbett House
Oxford Road
Manchester
M13 9WL
England
Greater Manchester Mental Health NHS Foundation Trust
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a publicly available repository. Data held on Edge Hill University's data repository will not risk confidentiality being broken; all data will be de-identified and anonymised.

Editorial Notes

12/02/2026: Study's existence confirmed by the HRA.