Emotion Regulation in Children (ERiC): an evaluation of mentalization-based treatment for school-age children with emotional and behavioural difficulties
| ISRCTN | ISRCTN11620914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11620914 |
| IRAS number | 316392 |
| Secondary identifying numbers | IRAS 316392, CPMS 53863 |
- Submission date
- 14/06/2022
- Registration date
- 28/11/2022
- Last edited
- 11/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
There were twice as many children and young people referred to Children and Young People’s Mental Health Services (CYPMHS) in 2020/21 compared with the previous 12 months. Many will present with mixed emotional and behavioural difficulties, but most mental health interventions are developed for single disorders. This means there is a lack of evidence-based interventions for this group that effectively target mechanisms underlying co-occurring mental health difficulties. There is a need for research on transdiagnostic interventions that target mechanisms underlying such mixed presentations, especially for school-age children (ages 6-12). Transdiagnostic interventions allow clinicians to address diverse diagnoses within a single treatment model, so limiting the training burden.
Difficulties with emotion regulation (the processes and strategies involved in regulating emotional states) present across a wide range of mental disorders and ER is the best-evidenced mechanism implicated in a range of common mental health disorders. One way in which to promote adaptive emotion regulation is by attending to the capacity to understand oneself and others in terms of underlying mental states (mentalizing). The ability to mentalize one’s own experiences and those of others plays a key role in coping with stress, regulating emotions, and forming stable relationships. MBT is a well-evidenced therapy for a range of populations that aims to promote mentalization, which in turn increases ER capacities, leading to decreased emotional and behavioural difficulties. Until now, children aged under 12 years have not had the benefit of this transdiagnostic approach, as the evidence for its effectiveness in this population has not yet been examined. The aim of this study is to test the clinical- and cost-effectiveness of MBT for school-age children with emotional and behavioural difficulties. If effective, it is hoped that this scalable, transdiagnostic approach can become available to the growing number of children presenting to mental health services with a mix of emotional and behavioural difficulties. In addition, it may enable a more efficient allocation of health and social care resources by reducing the need for longer-term, more intensive specialist mental health interventions.
Who can participate?
Children referred to a range of CYPMHS aged 6-12 years with mixed mental health problems (emotional and behavioural) as the primary problem, and their parent/carers
What does the study involve?
Children will be randomly allocated to MBT (treatment group) or treatment as usual (control) and will receive treatment within the service they were referred to. MBT consists of 6-8 sessions, delivered fortnightly, which can flexibly involve different members of the family, with a primary focus on promoting mentalizing and emotion regulation in the parent-child relationship. Treatment as usual will be the usual care provided in the referring service, likely to include CBT, parenting groups, and/or children’s social skills groups over 6-8 weeks. Parent/carers and children will be asked to complete outcome assessments (questionnaires and tasks) online at the start of treatment, mid-treatment, at the end of treatment and at follow-up.
What are the possible benefits and risks of participating?
Participants will have the chance of receiving MBT. For school-age children, there is preliminary evidence that promoting a child's mentalizing capacity can improve emotion regulation and children’s behavioural and emotional difficulties. As with any therapy, there is potential for some distress for participants as part of exploring painful experiences.
where is the study run from?
The study is being run by the Anna Freud National Centre for Children and Families (AFNCCF), a registered mental health charity. The ERiC study brings together a team of researchers from AFNCCF, University College London (UCL) and Children and Young People’s Mental Health Services (CYPMHS) (UK).
When is the study starting and how long is it expected to run for?
January 2022 to May 2026
Who is funding the study?
1. The Kavli Trust (Norway)
2. Anna Freud Centre (UK)
Who is the main contact?
Nick Midgley, nick.midgley@annafreud.org
eric@annafreud.org
Contact information
Principal Investigator
Anna Freud Centre
4-8 Rodney Street
London
N1 9JH
United Kingdom
 ORCID ID |
0000-0002-6263-5058 |
|---|---|
| Phone | +44 (0)20 7794 2313 |
| nick.midgley@annafreud.org |
Public
Anna Freud Centre
4-8 Rodney Street
London
N1 9JH
United Kingdom
| Phone | +44 (0)20 7794 2313 |
|---|---|
| eric@annafreud.org |
Scientific
Anna Freud Centre
4-8 Rodney Street
London
N1 9JH
United Kingdom
| Phone | +44 (0)20 7794 2313 |
|---|---|
| eric@annafreud.org |
Study information
| Study design | Pragmatic multicentre individually randomized superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 41922 Parent PIS v1.2 13Oct2022.pdf |
| Scientific title | Emotion Regulation in Children (ERiC): a randomised clinical trial to evaluate the clinical and cost-effectiveness of mentalization-based treatment vs treatment as usual for school-age children with mixed emotional and behavioural difficulties |
| Study acronym | ERIC |
| Study hypothesis | This study aims to evaluate the clinical- and cost-effectiveness of mentalization-based treatment (MBT) in improving mental health outcomes for children aged 6-12 with mixed (internalizing and externalizing) mental health problems. Hypothesis 1: Children allocated to MBT will experience a significantly greater reduction in mental health problems – both internalizing and externalizing – when compared with the TAU group. Hypothesis 2: Families allocated to MBT will also experience a greater improvement in a range of secondary outcomes, including quality of life, improved capacity for emotion regulation, and decreased parental stress, and a reduction in health and social service use and costs compared to the treatment as usual (TAU) group. Hypothesis 3: The impact of treatment on child mental health will be mediated, in part, by changes in capacity for emotion regulation (in both parent and child). The Implementation and Process Evaluation (IPE) aims to investigate: a) model fidelity, b) the experience of MBT (including the change process) from the perspective of service users; and c) any barriers to implementation and scalability post-trial. |
| Ethics approval(s) | Approved 15/09/2022, London – Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester M1 3DZ, UK; +44 2071048272; Bloomsbury.rec@hra.nhs.uk), ref: 22/LO/0591 |
| Condition | Mental health in school-age children with mixed emotional and behavioural problems |
| Intervention | Current interventions as of 11/09/2024: Participants will be recruited in children's mental health services (including Child and Adolescent Mental Health Services (CAMHS), Mental Health Support Teams (MHSTs) and community services) and the interventions in both arms will be delivered by clinicians working in those services. Clinicians will be randomly selected to either deliver MBT or treatment as usual (TAU). Clinicians will be stratified by profession and level of experience. The MBT intervention will be a manualized, transdiagnostic model designed for children aged 6-12 and their carers. It aims to promote adaptive ER by attending to the capacity to understand oneself and others in terms of underlying mental states. MBT consists of 6-8 sessions, delivered fortnightly, which can flexibly involve different members of the family, with a primary focus on promoting mentalizing and emotion regulation in the parent-child relationship. The control group will be offered treatment as usual (TAU). As there is no single evidence-based treatment for this group, and because practice is not standardised across children's mental health services in England, TAU is likely to include CBT, parenting groups, and/or children’s social skills groups. Participants will be randomized to either MBT or TAU, stratified by service and age group (6-9 years and 10-12 years old), using permuted blocks of size 4 within each stratum. Parents/carers and children will not be blind to the intervention group, but the research team conducting data collection and analysis will be blind. Previous interventions: Participants will be recruited in Child and Adolescent Mental Health Services (CAMHS) and the interventions in both arms will be delivered by clinicians working in CAMHS. Therapists will be randomly selected to either deliver MBT or treatment as usual (TAU). Therapists will be stratified by profession and level of experience. The MBT intervention will be a manualized, transdiagnostic model designed for children aged 6-12 and their carers. It aims to promote adaptive ER by attending to the capacity to understand oneself and others in terms of underlying mental states. MBT consists of 6-8 sessions, delivered fortnightly, which can flexibly involve different members of the family, with a primary focus on promoting mentalizing and emotion regulation in the parent-child relationship. The control group will be offered treatment as usual (TAU). As there is no single evidence-based treatment for this group, and because practice is not standardised across child and adolescent mental health services (CAMHS) in England, TAU is likely to include CBT, parenting groups, and/or children’s social skills groups. Participants will be randomized to either MBT or TAU, stratified by CAMH service and age group (6-9 years and 10-12 years old), using permuted blocks of size 4 within each stratum. Parents/carers and children will not be blind to the intervention group, but the research team conducting data collection and analysis will be blind. |
| Intervention type | Behavioural |
| Primary outcome measure | Emotional (anxiety and depression) and behavioural (ADHD and conduct) symptoms are measured using the parent-rated Strengths and Difficulties Questionnaire: Total Difficulties Score (SDQ) at baseline, 8 weeks (mid-treatment), 16 weeks (end of treatment) and 40 weeks (follow up) |
| Secondary outcome measures | 1. Emotional and behavioural problems measured using Me and My Feelings self-report measure for children at baseline, 8 weeks, 16 weeks and 40 weeks 2. Personalized treatment goals measured using Goal Based Outcomes (parent/carer-defined) completed by carers at baseline, 8 weeks, 16 weeks and 40 weeks 3. Parenting stress measured using Parental Stress Index – Short Form parent-report at baseline, 8 weeks, 16 weeks and 40 weeks 4. Parental mentalizing capacity measured using the Parental Reflective Functioning Questionnaire parent-report at baseline, 8 weeks, 16 weeks and 40 weeks 5. Service use and costs, measured using the Child and Adolescent Service Use Schedule questionnaire at baseline, 16 weeks and 40 weeks 6. Emotion regulation in child and parent will be measured using: 6.1. The Emotional Awareness Questionnaire child self-report at baseline, 8 weeks, 16 weeks and 40 weeks 6.2. The Test of Emotional Comprehension online task at baseline and 16 weeks 6.3. The Emotion Regulation Checklist for Children parent-report at baseline, 8 weeks, 16 weeks and 40 weeks 6.4. The Difficulties in Emotion Regulation Scale parent report at baseline, 8 weeks, 16 weeks and 40 weeks 6.5. The Parent-Child Interaction Task – a parent-child discussion task at baseline and 16 weeks |
| Overall study start date | 20/01/2022 |
| Overall study end date | 31/05/2026 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 320 |
| Participant inclusion criteria | Current inclusion criteria as of 11/09/2024: 1. Child aged 6-12 years at the time of randomisation 2. Carer-reported Strengths and Difficulties Questionnaire (SDQ): 2.1. Total difficulties score for child ≥14 2.2. Emotional problems ≥5 AND/OR conduct score ≥3 2.3. Functional impairment score ≥1 3. Valid informed consent 4. Parent(s)/carer(s) have the capacity to engage with the trial, including providing informed consent and completing baseline and follow-up measures Previous inclusion criteria: 1. Child aged 6-12 years at the time of randomisation 2. Carer-reported Strengths and Difficulties Questionnaire (SDQ): 2.1. Total difficulties score for child ≥14 2.2. Emotional problems ≥5 2.3. Conduct score ≥3 2.4. Functional impairment score ≥1 3. Valid informed consent |
| Participant exclusion criteria | Current exclusion criteria as of 11/09/2024: 1. Indications of, or pre-existing clinical diagnosis in child of psychotic disorder 2. Indications of, or pre-existing clinical diagnosis in child of eating disorder 3. Indications of, or pre-existing clinical diagnosis in child of severe learning difficulty 4. Children will be excluded where the referring clinician identifies an immediate risk of harm to self or others 5. Current participation in another mental health intervention trial. This includes where the family has previously participated in the ERiC study. 6. Children with a sibling, or another child who lives in their home, who has taken part in the ERiC study Previous exclusion criteria: 1. Indications of, or pre-existing clinical diagnosis (in child or parent) of psychotic disorder 2. Indications of, or pre-existing clinical diagnosis (in child or parent) of autism spectrum disorder (ASD) 3. Indications of, or pre-existing clinical diagnosis (in child or parent) of psychotic disorder 4. Indications of, or pre-existing clinical diagnosis (in child or parent) of pervasive developmental disorder 5. Indications of, or pre-existing clinical diagnosis (in child or parent) of eating disorder 6. Indications of, or pre-existing clinical diagnosis (in child or parent) of severe learning difficulty 7. Indications of, or pre-existing clinical diagnosis (in parent) of severe substance abuse disorder 8. Children will be excluded where the referring clinician identifies an immediate risk of harm to self or others |
| Recruitment start date | 04/04/2023 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St Ann's Road
London
N15 3TH
United Kingdom
Sandford Road
Littlemore
Oxford
OX4 4XN
United Kingdom
The Countess of Chester Health Park
Liverpool Road
Chester
CH2 1BQ
United Kingdom
Meadow Park
Meadow Lane
St. Ives
PE27 4LG
United Kingdom
Carholme Court
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
2nd Floor
2 Bristol Avenue
Colindale
London
NW9 4EW
United Kingdom
North Shields
NE27 6DQ
United Kingdom
21 Pinner Road
Harrow
HA1 4ES
United Kingdom
Perceval House
2nd Floor blue area
14-16 Uxbridge Road
Ealing
London
W5 2HL
United Kingdom
Sponsor information
Charity
4-8 Rodney Street
London
N1 9JH
England
United Kingdom
| Phone | +44 (0)20 7794 2313 |
|---|---|
| info@annafreud.org | |
| Website | http://www.annafreud.org/ |
"ROR" |
https://ror.org/0497xq319 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Kavli Trust, Kavli Trust, O. Kavli og Knut Kavlis Almennyttige Fond
- Location
- Norway
No information available
Results and Publications
| Intention to publish date | 01/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Five publications are planned, including the protocol in high impact peer review journals between November 2022 and May 2026. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository, the UCL Research Data Depository (https://www.ucl.ac.uk/library/open-science-research-support/research-data-management/ucl-research-data-repository). Only fully anonymised questionnaire data and task scores will be shared. The data will become available after the core research team has completed all planned analyses and they are published. It will be retained for a minimum of 10 years (the funder has made no requirements for data sharing) and this will be specified in the PIS. Access will be provided to registered researchers via request to UCL. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 13/10/2022 | 25/11/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 17/08/2023 | 18/08/2023 | Yes | No |
Additional files
Editorial Notes
11/09/2024: The following changes were made to the study record:
1. The interventions, inclusion and exclusion criteria were updated.
2. Cheshire and Wirral Partnership NHS Foundation Trust, Cambridgeshire Community Services NHS Trust, Lincolnshire Partnership NHS Foundation Trust Hq, Barnet Integrated Clinical Services, Riverside Family Hub, Harrow Horizons and Ealing SAFE Evolve were added to the study participating centres.
3. The recruitment end date was changed from 03/02/2025 to 31/07/2025.
4. The overall study end date was changed from 31/12/2025 to 31/05/2026.
18/08/2023: Publication reference added.
20/04/2023: The recruitment start date has been changed from 15/03/2023 to 04/04/2023.
15/02/2023: The recruitment start date has been changed from 01/02/2023 to 15/03/2023.
14/06/2022: Trial's existence confirmed by the Kavli Trust.
