Improving mental health support for children with unusual sensory experiences through a new talking therapy and parent training program
| ISRCTN | ISRCTN12245618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12245618 |
| IRAS number | 327343 |
| Secondary identifying numbers | CPMS 55761, IRAS 327343 |
- Submission date
- 29/05/2024
- Registration date
- 14/06/2024
- Last edited
- 09/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Distressing sensory experiences, such as hearing voices, seeing visions, or feeling presences others don't, are often associated with emerging signs of psychosis. Consequently, these experiences are surrounded by stigma, which can make young people and their parents very anxious. It is this anxiety that often leads young people and families to seek help from children’s mental health services. Very few of these children will receive a diagnosis of early-onset psychosis, but the anxiety surrounding distressing sensory experiences can cause difficulties for the young person in their day-to-day lives, schooling, and relationships. Anxiety about distressing sensory experiences can make the symptoms more frightening and harder to ignore, which is why it is so important children and families can access timely support. In the UK, there are currently no specialist interventions for these children, even though around half of children in mental health services report distressing sensory experiences, some of whom desperately need tailored support. Many mental health practitioners feel ill-equipped to offer psychological therapies for distressing sensory experiences due to a lack of national clinical guidelines and child-centred research to inform their approach. Therefore, parents, carers and young people can spend years trying to find help. Delayed access to support increases anxiety further, exacerbates family stress and often worsens the original symptoms. Parents have explained: “There is a massive gap in services with zero services being available for someone experiencing voices so young”. Without suitable support, the overall well-being of the family can decrease rapidly, reducing their ability to cope.
Building upon the extensive research of the team to date and national stakeholder consultations, this study will trial a new approach to supporting young people and their parents to learn new information and coping skills, which aim to improve their overall well-being and reduce future risks to their mental health. This study aims to evaluate the feasibility and acceptability of conducting a future larger-scale definitive efficacy and cost-effectiveness trial of brief psychological therapy for young people (8-15 years old) with distressing sensory experiences, with an accompanying parent-training programme.
Who can participate?
Young people aged 8-15 years old experiencing distressing sensory experiences and their parent(s)
What does the study involve?
The study has two parts. Firstly, the researchers will ask children and their parents to take part in a short talking therapy intervention and parent-training programme to develop skills and understanding of their distressing sensory experiences. Another group of children will join the study and receive the care that would usually be provided. This intervention will be based in Child and Adolescent Mental Health Services to help children and parents when they initially seek help. Secondly, the children, parents/carers and practitioners who take part will be invited to give detailed feedback about their participation to see what difference the intervention makes, learning from their insights.
What are the possible benefits and risks of participating?
Benefits
1. Improved Understanding and Coping Skills:
Children will learn to understand and manage their distressing sensory experiences, which can reduce anxiety and improve their daily lives.
2. Enhanced Support for Parents:
Parents will gain skills and knowledge through the parent-training program, helping them better support their children.
3. Reduced Anxiety and Stress:
Early and appropriate intervention can help reduce anxiety and stress for both children and their families.
4. Better Day-to-Day Functioning:
With improved coping mechanisms, children may experience fewer disruptions in their schooling, relationships, and overall daily activities.
5. Timely Access to Specialized Care:
Participation in the study provides access to a specialized intervention that is currently unavailable in typical NHS services.
6. Contributing to Future Services:
By providing feedback, participants will help shape future mental health services, ensuring that other children and families receive better support in the future.
7. Overall Family Wellbeing:
Improved mental health support can enhance the overall wellbeing of the family, helping them cope more effectively with distressing sensory experiences.
Risk
1. The proposed intervention offers a novel, tailored and theoretically informed approach to support children already in CAMHS and receiving non-tailored talking therapy. Compared to normal standard practice, the proposed intervention should pose less risk as its development has been theoretically informed and co-produced throughout six years of primary and secondary research, and co-production.
2. Due to the brief nature of the proposed intervention, the frequency of risk should be lower than current practice, which is non-tailored, not standardised, and variable in quality and length.
3. A dedicated trial therapist and highly trained research team will ensure that the intervention is delivered and evaluated to the highest quality, with participant care in mind at all times.
This trial is categorised as Type A = No higher than the risk of standard medical care.
Where is the study run from?
The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
February 2024 to August 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Sarah Parry, sarah.parry@manchester.ac.uk
Contact information
Public, Scientific, Principal Investigator
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 6000 |
|---|---|
| sarah.parry@manchester.ac.uk |
Study information
| Study design | Feasibility multicentre single-blind parallel-group randomized controlled trial with a nested process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Built environment/local authority, Community, Telephone |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Improving access to psychological therapies for children with distressing sensory experiences: the feasibility and acceptability of the ChUSE trial, a novel child-focused and parent intervention |
| Study acronym | ChUSE |
| Study objectives | 1. Is the ChUSE intervention acceptable to children/young people with unusual sensory experiences? 2. Is the ChUSE intervention acceptable to parents/carers of children with unusual sensory experiences? 3. Is the ChUSE parent training program acceptable to parents/carers of children with unusual sensory experiences? |
| Ethics approval(s) |
Approved 02/05/2024, Health Research Authority/ Health and Care Research Wales (19 Cowbridge Rd E, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 230457; healthandcareresearch@wales.nhs.uk), ref: 24/WM/0054 |
| Health condition(s) or problem(s) studied | Distressing sensory experiences (DSE) |
| Intervention | The trial will be a single-blind parallel-group RCT with two arms: 1. Brief psychological intervention involving four sessions of talking therapy for the children/young people with distressing sensory experiences, and the optional offer of a three-session parent training program, plus treatment as usual (TAU) 2. TAU alone The psychological intervention will include the following: Session 1: Psychoeducation, normalisation, externalisation techniques Session 2: Multisensory coping strategies based on compassion-focused therapy skills Session 3: Cognitive appraisal, coping skills practice, simple self-formulation training. Session 4: Compassion-focused reflection and coping skills consolidation. The parent program will include: Session 1: 1. Psychoeducation, normalisation and re-appraisal 2. Therapist-guided, scenario-based, problem-solving Q&A 3. Homework: reading a brief psychoeducation guide Session 2: 1. Introduction to compassion-focused coping strategies 2. Self-kind self-talk and containment 3. Homework: skills practice Session 3: 1. Therapist-guided compassionate reflection upon coping skills practice 2. Consolidation of new knowledge and skills Randomisation will be independent and concealed, via an online pseudo-random list hosted by sealedenvelope.com with random permuted blocks of varying sizes. Key outcomes will be assessed at baseline (T0), end of intervention (3 months post-randomisation; T1) at which point participants will also be invited to take part in qualitative interviews, and 6 months post-randomisation (T2). |
| Intervention type | Behavioural |
| Primary outcome measure | The principal feasibility outcomes will be: 1. Trial recruitment measured using study data to calculate the number of family units recruited and randomised per month 2. Trial retention measured using study data to calculate % of participants retained at each assessment point 3. Treatment engagement measured using study data to calculate the number of sessions attended by CYP and parents/carers allocated to the ChUSE intervention + TAU and TAU arm of the trial) at the end of the study 4. ChUSE intervention treatment fidelity measured using study data to calculate the extent to which the trial therapist can deliver the ChUSE intervention with high levels of treatment fidelity) at the end of the study 5. The safety of the ChUSE intervention for young people and parents/caregivers measured using information collected via detailed Adverse Event (AE) forms (e.g., number of AE and SAE related and unrelated to trial procedures and interventions) at the end of the study 6. The uptake of the parent training programme measured using treatment engagement data (i.e., number of parents who accept the PTP offer and number of sessions attended parents/carers) at the end of the study 7. The feasibility of collecting key outcome measures to inform the selection and data collection procedures for the future definitive trial measured using the completeness (i.e. % of missing responses and reasons for missingness) of the aforementioned and below outcome measures at the end of the study |
| Secondary outcome measures | The following secondary outcome measures will be evaluated at baseline, T1 (three months), and T2 (six months) using a range of self-report measures collected from both children and young people (CYP) and their parents/guardians: The ‘promise of efficacy’ of the ChUSE intervention and the necessary parameters to inform a sample size calculation for a future efficacy trial. Measures for CYP: 1. Symptom Level measured using: 1.1. Manchester Voices Inventory for Children (MAVIC) 1.2. Unusual Experiences Questionnaire (UEQ) 1.3. Brief Self-compassion Scale 2. Health-related quality of life outcomes measured using: 2.1. Stirling Children’s Wellbeing Scale 2.2. EQ-5D-Y 2.3. KidCOPE scale 2.4. Child Health Utility Instrument (CHU-9D) 2.5. Strengths and Difficulties Questionnaire Self-Report version for 11-17 year olds Measures for parents/guardians: 1. Health-related quality of life outcomes measured using: 1.1. SDQ-parent version 1.2. Adult Wellbeing Scale (parents/carers) 1.3. Parental Stress Scale (PSS), an 18-item questionnaire assessing parents' feelings about their parenting role, exploring positive [e.g. demands on resources, feelings of stress] 1.4. Coping Health Inventory for Parents (CHIP) 1.5. EQ-5D |
| Overall study start date | 01/02/2024 |
| Completion date | 31/08/2026 |
Eligibility
| Participant type(s) | Carer, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 8 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | Young people and their parent/parent pair (i.e., children and parent/carer dyads) will be eligible if: 1. The child is aged 8-15-years-old and self-identifies as experiencing DSE: due to the current lack of sensitivity of diagnostic or clinical threshold assessments of DSEs, young people who have been referred to CAMHS will automatically be considered eligible for inclusion if they report the presence of DSEs, which will be confirmed by the MAVIC 2. The child is currently under the care of CAMHS 3. At least one parent, primary carer or legal guardian provides consent for trial participation, and in line with Health Research Authority guidance for Research Involving Children, the child provides assent for inclusion into the trial |
| Key exclusion criteria | Children and parent/carer dyads will be excluded when: 1. Young people unable to engage in conversational English, as the intervention and trial assessments are currently only available in English. If a parent is unable to take part in the PTP, the young person can still engage in the young person’s ChUSE intervention. 2. The child experiences a mental health crisis requiring inpatient hospital admission at the time of study enrolment. The intervention is designed to be accessed as an early intervention on an outpatient basis, so those accessing inpatient CAMHS services will not be eligible for inclusion as they may have urgent clinical needs. 3. The child is already enrolled in another mental health clinical trial involving the provision of an active psychological treatment, as concomitant trial participation may be excessively burdensome and influence outcome assessment. |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Sponsor information
Other
Room FC027, 3rd Floor
Rawnsley Building
Hathersage Road
Manchester
M13 9WL
England
United Kingdom
| Phone | +44 (0)161 271 0722 |
|---|---|
| researchoffice@gmmh.nhs.uk | |
| Website | https://www.gmmh.nhs.uk// |
"ROR" |
https://ror.org/05sb89p83 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The researchers will work closely with the LEAG, PCG and SAB to develop a far-reaching, accessible and meaningful dissemination strategy. Based on prior PPI and ongoing stakeholder discussions, they anticipate the following will be important to consider. Due to the role stigma is thought to play in relation to symptom-related distress, public engagement around this study to raise awareness, reduce stigma and normalise young people’s experiences is particularly important. With the LEAG and PCG, the researchers will develop a short film to communicate research findings to participants, services and the public. Multimedia materials, e.g., podcasts, blogs and infographics, will promote the findings of the study to a broad public cross-section through social media. The researchers will also host a large event in Manchester for people who have been involved in the trial and would like to attend, mental health practitioners, service leads, Children’s Services Directors, commissioners, educators and social workers. Finally, to ensure geography is not a barrier, the researchers will hold at least one sector-wide webinar, hosted for free by ACAMH based on existing interest in Dr Sarah Parry and Prof Filippo Varese’s ACAMH publication on voice hearing in adolescence (8,228 engagements), to share findings and promote further opportunities for impact. Planned outputs: 1. A practitioner briefing report for CAMHS practitioners and service managers, with an addendum for commissioners. 2. A minimum of three high-quality journal publications. 3. Accessible media outputs in digital magazines with no paywall and a multimedia portfolio. 4. Based on PPIE conducted so far, the researchers envisage the implementation protocol will include the intervention protocol for practitioners to apply the brief interventions in a definitive trial, supplemented by stories from experience developed through the study, case studies to illustrate how to apply the elements of the intervention, reflections on practice to demonstrate learning and progress over time, and visual summaries to help practitioners discuss the intervention with young people. The researchers will also include a section on research-based learning for future research and service development initiatives that wish to build on this study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository |
Editorial Notes
09/07/2024: The recruitment start date was changed from 01/07/2024 to 01/09/2024.
11/06/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
