NCT07091721

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Nov 2025Jun 2027

First Submitted

Initial submission to the registry

July 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 14, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

The Mentalization Intervention for Children and Adolescents (MICA) study.Forensic Child and Adolescent Mental Health Services (FCAMHS).Aggressive and violent behaviour.Mentalization-Based Therapy.Conduct disorder.Mental Health.Young people.MBT-CD

Outcome Measures

Primary Outcomes (1)

  • Reactive and Proactive Aggression Questionnaire (child reported)

    The primary outcome is aggression and violent behaviour measured by the self-reported Reactive and Proactive Aggression Questionnaire. The RPQ combines two subscales, one measuring reactive aggression (12 items), the other proactive aggression (11 items). Each item is scored on a three-point scale from 0 (never) to 2 (often). Item scores from each subscale are added together to produce sub-scale scores (range 0-24 for reactive aggression, and 0-22 for proactive aggression). The total score can range from 0-46.

    Completed at baseline and six months post-baseline (primary endpoint).

Secondary Outcomes (7)

  • Strengths and Difficulties Questionnaire (child reported)

    Completed at baseline and six months post-baseline.

  • Emotion Awareness Questionnaire (child reported)

    Completed at baseline and six months post-baseline.

  • Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (child reported)

    Completed at baseline and six months post-baseline.

  • Reactive and Proactive Aggression Questionnaire (parent/carer reported)

    Completed at baseline and six months post-baseline.

  • Strengths and Difficulties Questionnaire (parent/carer reported)

    Completed at baseline and six months post-baseline.

  • +2 more secondary outcomes

Other Outcomes (2)

  • Therapeutic alliance (child reported)

    Will be assessed at three time points during 6 month reporting period: early therapy (defined as sessions/weeks 1-3), mid-therapy (defined as sessions/weeks 10-13), and late therapy (defined as sessions/weeks 20-24)

  • Goal based outcomes (child reported)

    Will be assessed at three time points during 6 month reporting period: early therapy (defined as sessions/weeks 1-3), mid-therapy (defined as sessions/weeks 10-13), and late therapy (defined as sessions/weeks 20-24)

Study Arms (2)

MBT

EXPERIMENTAL
Behavioral: Mentalization based therapy (MBT)

Support as usual

ACTIVE COMPARATOR
Other: Support as usual

Interventions

Mentalization based therapy for conduct disorder

MBT

Support usually provided by FCAMHS which may include advice/guidance to the professional network around the child/adolescent, psychoeducation, other mental health treatment e.g. CBT

Support as usual

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Southampton, Calmore, SO40 2RZ, United Kingdom

NOT YET RECRUITING

South London Community Forensic CAMHS , South London and Maudsley NHS Foundation Trust

Beckenham, Kent, BR3 3BX, United Kingdom

NOT YET RECRUITING

Yorkshire and Humber FCAMHS, South West Yorkshire Partnership NHS Foundation Trust

Wakefield, Ouchthorpe Lane, WF1 3SP, United Kingdom

RECRUITING

South Central Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust

Headington, Oxford, OX3 7JX, United Kingdom

NOT YET RECRUITING

South West (North) Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust

Headington, Oxford, OX3 7JX, United Kingdom

NOT YET RECRUITING

East Midlands Community Forensic Child & Adolescent Mental Health Service, Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Porchester Road, NG3 6AA, United Kingdom

NOT YET RECRUITING

The North East and North Cumbria Community Forensic Child & Adolescent Mental Health Service, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle upon Tyne, Upon Tyne and Wear, NE3 3XT, United Kingdom

NOT YET RECRUITING

East of England Community FCAMHS Team, Cambridgeshire and Peterborough NHS Foundation Trust

Cambridge, CB21 5EF, United Kingdom

NOT YET RECRUITING

Tavistock and Portman NHS Foundation Trust Forensic CAMHS, Tavistock and Portman NHS Foundation Trust

London, NW3 5BA, United Kingdom

NOT YET RECRUITING

North West London Forensic Child and Adolescent Mental Health Service , West London NHS Trust

Southall, UB2 4SD, United Kingdom

NOT YET RECRUITING

South West FCAMHS, Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

RECRUITING

Related Publications (2)

  • Hauschild S, Kasper L, Volkert J, Sobanski E, Taubner S. Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): a feasibility study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2611-2622. doi: 10.1007/s00787-022-02113-4. Epub 2022 Nov 25.

    PMID: 36434148BACKGROUND
  • Taubner S, Hauschild S, Kasper L, Kaess M, Sobanski E, Gablonski TC, Schroder-Pfeifer P, Volkert J. Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): protocol of a feasibility and pilot study. Pilot Feasibility Stud. 2021 Jul 2;7(1):139. doi: 10.1186/s40814-021-00876-2.

    PMID: 34215323BACKGROUND

Related Links

MeSH Terms

Conditions

Conduct DisorderAggressionAdolescent BehaviorPsychological Well-Being

Interventions

Mentalization-Based TherapyPalliative Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director of Evidence Based Practice Unit

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 29, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All anonymous study data (and name, date of birth and postcode) will be securely transferred to the Department for Education (DfE). The DfE will replace all identifying information about the young people who have taken part in the study (their name, date of birth, and postcode) with the young person's unique Pupil Matching Reference number in the DfE's National Pupil Database. The DfE will transfer this data to the YEF archive, which is stored in the Office for National Statistics' Secure Research Service. Access to the anonymised data may be granted to other researchers through controlled procedures governed by the YEF Data Archive. Anonymised data will also be retained by the University of Hertfordshire and Anna Freud Centre for up to 10 years to support secondary analysis and related research outputs. This may or may not involve sharing data with other researchers, contributing to a larger data set.

Locations