Mental health intervention for children with epilepsy
| ISRCTN | ISRCTN57823197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57823197 |
| Secondary identifying numbers | 18PP14 |
- Submission date
- 05/02/2019
- Registration date
- 25/02/2019
- Last edited
- 11/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
At least half of children with epilepsy also have mental health problems like depression, anxiety and behaviour problems. The mental health problems impact so much on all areas of life including family, friendships and education, that the National Institute for Health and Care Excellence recommends the psychological needs of children with epilepsy should always be considered. However, existing epilepsy services are separate from mental health services, so mental health problems aren’t treated as well as they could be. There is an exciting new psychological treatment for childhood anxiety, depression and behavioural problems. This Modular Approach to Treatment for Children – Anxiety, Depression, Trauma or Conduct (MATCH-ADTC) can be given within epilepsy services, by staff without special mental health training and over the phone/Skype, which many families prefer and which reduces costs to the NHS so more children can be treated nationwide. The treatment is flexible so can be given to parents and/or the child according to age and type of problem. The purpose of the first stage of the research programme was to develop a new epilepsy-specific module to include in MATCH-ADTC and to integrate epilepsy-relevant content throughout MATCH-ADTC, so that MATCH-ADTC meets the special mental health needs of children with epilepsy. The purpose of the second stage is to work with staff and patients in epilepsy services to integrate the personalised, modular psychological intervention developed in stage one within existing service models so that it can be delivered with competence, fidelity and flexibility in a sustainable manner. The aim of the third stage is to evaluate the clinical and cost-effectiveness of MATCH-ADTC delivered by the therapists trained in stage two in addition to standard care, compared to standard care alone, for children with common mental health disorders and epilepsy.
Who can participate?
Young people aged 3 – 18 years old who are attending epilepsy clinics and have a common mental health disorder can participate.
What does the study involve?
The study compares MATCH-ATDC in addition to usual care compared to usual care alone. Half of the participants will be randomly allocated to received MATCH-ATDC in addition to usual care, and half of the participants will be randomly allocated to receive usual care alone.
What are the possible benefits and risks of participating?
Participants may benefit by taking part as they may receive additional support for emotional or behavioural difficulties. There are no specific risks from taking part in the study. Participants will not be deprived of any treatment that they would otherwise have received had they not been a part of the study. It is possible that thinking about their life and the effect of having epilepsy could be upsetting for participants. It is possible that the questionnaires and interviews may cause distress as they address sensitive issues.
Where is the study run from?
There are seven centres taking part in this study. These are Great Ormond Street Hospital for Children NHS Foundation Trust (the lead centre), University College London Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, North East London NHS Foundation Trust, Lewisham & Greenwich NHS Trust, Royal Free NHS Foundation Trust, Whittington Health NHS Trust.
When is the study starting and how long is it expected to run for?
October 2018 to April 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Roz Shafran
gos-tr.mice@nhs.net
Contact information
Public
UCL Great Ormond Street Institute of Child Health
30 Guildford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7242 9789 |
|---|---|
| gos-tr.mice@nhs.net |
Study information
| Study design | A randomized controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not availabe in web format, plesae use contact details to request a participant information sheet. |
| Scientific title | A randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy |
| Study acronym | MICE |
| Study objectives | The study hypothesis is that MATCH-ADTC in addition to usual care will be more clinically and cost-effective than usual care alone for young people with epilepsy and common mental health disorders. |
| Ethics approval(s) | South Central - Oxford A Research Ethics Committee, Bristol Research Ethics Committee Centre, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT, Tel: +44 (0)207 104 8028, Email: nrescommittee.southcentral-oxforda@nhs.net, 15/05/2018, REC ref: 18/SC/0250 |
| Health condition(s) or problem(s) studied | Children and young people with common mental health disorders and epilepsy |
| Intervention | Participants will be randomised to one of two treatment groups. Half of the participants will receive MATCH-ADTC in addition to usual care, and half of the participants will be receive usual care alone. The intervention is MATCH-ADTC (a personalised modular psychological intervention) with epilepsy-relevant content integrated throughout it and an additional epilepsy-specific module added in addition to usual care delivered by non-mental health specialists, over the telephone/Skype, within epilepsy services, for young people with epilepsy who have common mental health disorders. MATCH-ADTC can be delivered within epilepsy services, by a wide range of health workers, over the telephone/Skype which will facilitate early intervention, maximise access, and minimise stigma, disruption and cost. MATCH-ADTC is an average of 16 sessions of therapy (minimum 10 and maximum 22 sessions) delivered over 4-6 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Total difficulties score from the Strengths and Difficulties Questionnaire reported by the parent/carer measured at baseline, 6 months and 12 months |
| Secondary outcome measures | 1. Mental health diagnosis according to the Development and Wellbeing Assessment (DAWBA) measured at baseline, 6 months and 12 months. 2. Anxiety and depression measured by the Revised Children’s Anxiety and Depression Scale (RCADS) measured at baseline, 6 months and 12 months. 3. Number and severity of adverse events measured at baseline, 6 months and 12 months. 4. Seizure severity measured by the Hague Seizure Severity Scale measured at baseline, 6 months and 12 months. 5. Quality of life measured by the EuroQol 5-dimensions measures, five-level version (EQ-5D-5L) measured at baseline, 6 months and 12 months. 6. Quality of life measured by the Paediatric Quality of Life measures (PedsQL) – Epilepsy Module measured at baseline, 6 months and 12 months. 7. Service use measured by the Child and Adolescent Service Use Schedule (CA-SUS) measured at baseline, 6 months and 12 months. 8. Health utility measured by the Child Health Utility 9-dimensions (CHU-9D) measured at baseline, 6 months and 12 months. 9. Intelligence measured by the Peabody Picture Vocabulary Test (PPVT) at baseline 10. School attendance (self-reported) measured at baseline, 6 months and 12 months. 11. School performance (self-reported) measured at baseline, 6 months and 12 months. 12. Session-by-session measures (e.g. goal based outcomes) measured at baseline and after each therapy session. 13. Measures allowing for therapist self-rating of competence in delivering treatment and adherence to the treatment manual measured at baseline and after therapy is completed |
| Overall study start date | 30/10/2018 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 334 |
| Total final enrolment | 334 |
| Key inclusion criteria | 1. Attending clinics for the treatment of epilepsy 2. Aged 3-18 years 3. Meeting DSM-5 diagnostic criteria for a mental health disorder (e.g. depression, anxiety, disruptive behaviour or trauma) identified by the SDQ, DAWBA and clinical assessment 4. Have a parent/carer who is also willing to take part in the study |
| Key exclusion criteria | 1. Not speaking/understanding English sufficiently well to access the screening assessments 2. Having an intellectual disability at a level meaning that they cannot access the measures and/or intervention 3. Screening results that indicate a severe mental health disorder not considered suitable for the trial intervention 4. Actively receiving intensive psychological input focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties at the time of the assessment or due to have such input during the study period 5. Refusing to consent to the research team contacting their GP/other relevant health professionals about their inclusion in the research 6. Refusing to have the trial therapy sessions audio and/or video recorded 7. Aged 16+ and unable to consent for themselves 8. Unable to complete the measures despite all reasonable efforts being made to assist |
| Date of first enrolment | 30/04/2019 |
| Date of final enrolment | 30/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
WC1N 3JH
United Kingdom
London
NW1 2PG
United Kingdom
Exeter
EX2 5DW
United Kingdom
Rainham
RM13 8GQ
United Kingdom
Lewisham
SE13 6LH
United Kingdom
Barnet
EN5 3DJ
United Kingdom
London
N19 5NF
United Kingdom
Sponsor information
Hospital/treatment centre
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Website | https://www.gosh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The protocol is currently being updated but will be available on request, and may be published in due course. The statistical analysis plan has not yet been finalised. The results of the trial will be published in peer reviewed scientific journals, and the result disseminated through conference presentations. |
| IPD sharing plan | Current IPD sharing plan as of 13/10/2023: The data is being held in the secure drive at GOSH and/or UCL Data Safe Haven. Participant-level data will not be made available for reasons of confidentiality. Some of the patients have rare forms of epilepsy and sharing their data could identify them. Previous IPD sharing plan: Participant-level data may be available on request. Any requests for participant-level data would be carefully considered by the Programme Steering Committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 11/02/2021 | 14/04/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 3.0 | 03/10/2022 | 12/10/2023 | No | No |
| Results article | 07/03/2024 | 11/03/2024 | Yes | No |
Additional files
Editorial Notes
11/03/2024: Publication reference added.
13/10/2023: IPD sharing statement updated.
12/10/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded.
2. Total final enrolment added.
3. The overall study end date was changed from 31/10/2023 to 01/04/2023.
4. The intention to publish date was changed from 30/10/2023 to 31/12/2023.
14/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 30/04/2022.
2. The overall end date was changed from 31/10/2022 to 31/10/2023.
3. The intention to publish date was changed from 30/10/2022 to 30/10/2023.
4. The plain English summary was updated to reflect these changes.
5. The trial website was added.
6. Publication reference added.
