Using Mentalization Based Therapy to Support Children and Adolescents Referred to Specialist Ment… (NCT07091721) | Clinical Trial Compass
RecruitingNot Applicable
Using Mentalization Based Therapy to Support Children and Adolescents Referred to Specialist Mental Health Services in the NHS for Aggressive and/or Violent Behaviour
United Kingdom632 participantsStarted 2025-12-03
Plain-language summary
The MICA Study is a research project that has been designed to work out how helpful mentalisation based therapy is. This is a new type of support that helps young people make sense of their own behaviours and feelings, and those of others. It involves meeting regularly with a mental health practitioner and parents/carers can be involved in some meetings too. It is hoped that this new type of support will help young people stop acting aggressively/violently.
This project will be delivered in Forensic Child and Adolescent Mental Health Services (FCAMHS) in England. This service supports some of the most vulnerable young people in the country, who may also have involvement from other professionals including the Youth Justice System.
The aim of the research is to make the support better for young people who use these services. This research involves doing a randomised controlled trial. This means half the young people will get the usual support from FCAMHS, and half will get the usual support plus the new support. The results will be used to compare mentalisation based therapy to the support FCAMHS usually provides. This will show the best way to support young people with their aggressive/violent behaviours.
To start with, young people will answer a questionnaire. Following this, young people will receive either usual support or usual support plus MBT for six months. After this, young people will answer a questionnaire again. Some young people will be asked to take part in an optional interview to share their thoughts on this research. All young people aged 10-17 years who have been referred to a FCAMHS in England will be asked to take part, as long as they can speak and understand English. Some young people might not want to take part in this research and that will not change the support they receive.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 10-17 years at the time of referral;
* Aggression and/or violence are indicated at referral or assessment;
* Participation in the evaluation would not interfere with statutory orders;
* Child and parent/carer (for children 10-15 years) are able to consent and engage with the study materials;
* Living in the community at time of referral and no imminent plans to move to hospital, residential, or secure settings.
Additional inclusion criteria for participants recruited from a clinician's existing caseload:
* There has been no direct contact between child and FCAMHS clinicians, including assessments.
* There has been no indirect therapeutic support provided by FCAMHS e.g. advising non-FCAMHS professionals on therapeutic support.
* It is permissible for the clinician to have previously engaged in consultation activities where these did not involve contact with the child.
Exclusion Criteria:
* Age under 10 or age 18 or older at the time of referral;
* No evidence of aggression and/or violence indicated at referral or assessment;
* FCAMHS are only offering a one-off consultation or assessment (e.g., the network around the child requires support to manage risk but additional input is not required);
* Child's level of English is not sufficient to engage in the intervention;
* Child and/or parents/carers refuse to engage with FCAMHS;
* No statutory service is involved in supporting the child;
* No statutory service will agree to hold the child's case ope…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reactive and Proactive Aggression Questionnaire (child reported)
Timeframe: Completed at baseline and six months post-baseline (primary endpoint).