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Recruiting NCT07091721

NCT07091721 Using Mentalization Based Therapy to Support Children and Adolescents Referred to Specialist Mental Health Services in the NHS for Aggressive and/or Violent Behaviour

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Clinical Trial Summary
NCT ID NCT07091721
Status Recruiting
Phase
Sponsor Anna Freud
Condition Conduct Disorder
Study Type INTERVENTIONAL
Enrollment 632 participants
Start Date 2025-12-03
Primary Completion 2027-06

Eligibility & Interventions

Sex All sexes
Min Age 10 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Mentalization based therapy (MBT)Support as usual

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 632 participants in total. It began in 2025-12-03 with a primary completion date of 2027-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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 open for a minimum of six months. * Currently involved in another psychological intervention research study.

Frequently Asked Questions

Who can join the NCT07091721 clinical trial?

This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Conduct Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07091721 currently recruiting?

Yes, NCT07091721 is actively recruiting participants. Visit ClinicalTrials.gov or contact Anna Freud to inquire about joining.

Where is the NCT07091721 trial being conducted?

This trial is being conducted at Southampton, United Kingdom, Wakefield, United Kingdom, Headington, United Kingdom, Headington, United Kingdom and 4 additional locations.

Who is sponsoring the NCT07091721 clinical trial?

NCT07091721 is sponsored by Anna Freud. The trial plans to enroll 632 participants.

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