AzTrials
AzTrials

Conduct DisorderMICANCT07091721

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

A study testing Mentalization based therapy (MBT) and Support as usual in people with Conduct Disorder and Mentalization Based Therapy, run by Anna Freud at 8 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
Mentalization based therapy (MBT) and Support as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
632 participants
Where
8 sitesUnited Kingdom
Study dates
3 Dec 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United Kingdom8 sites, 8 recruiting
  • East of England Community FCAMHS Team, Cambridgeshire and Peterborough NHS Foundation Trust

    Cambridge, CB21 5EF

    Charlotte Proctor, MSc, charlotte.procter@cpft.nhs.uk

    Not yet recruiting
  • South Central Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust

    Headington, Oxford, OX3 7JX

    Denise Davis, MSc, +441865 902613, Denise.Davis@oxfordhealth.nhs.uk

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

    Headington, Oxford, OX3 7JX

    Andrew Newman, DClinPsy, +4401865 903038, Andrew.Newman@oxfordhealth.nhs.uk

    Recruiting
  • North London Forensic CAMHS, North London NHS Foundation Trust

    London, NW3 5BA

    Louisa Stokou, DClinPsy, LStokou@Tavi-Port.nhs.uk

    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

    Patrick Kennedy, DClinPsy, +440191 245 6629, jack.kennedy@gmail.com

    Recruiting
  • Hampshire and Isle of Wight Healthcare NHS Foundation Trust

    Southampton, Calmore, SO40 2RZ

    Jonathan Bigg, MRCPsych, Jonathan.bigg@southernhealth.nhs.uk

    Not yet recruiting
  • South West FCAMHS, Somerset NHS Foundation Trust

    Taunton, TA1 5DA

    James Randall, DClinPsy, +443001245014, James.Randall@somersetft.nhs.uk

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

    Wakefield, Ouchthorpe Lane, WF1 3SP

    Naomi Callender, PGDip, +441924 316066, naomi.callender1@swyt.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: The Mentalization Intervention for Children and Adolescents (MICA) Study: A Randomised Controlled Trial of Support for Aggressive and Violent Behaviour Via Forensic Child and Adolescent Mental Health Services (FCAMHS)

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.

Read more

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.

Being tested
Mentalization based therapy (MBT), Support as usual
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
Medical subject headings
Conduct Disorder, Aggression, Adolescent Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mentalization based therapy (MBT)Behavioural

    Mentalization based therapy for conduct disorder

  • Support as usualOther

    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

Study groups in NCT07091721
Study groupRoleWhat they receive
MBTExperimentalNot described
Receives: Behavioral: Mentalization based therapy (MBT)
Support as usualActive comparatorNot described
Receives: Other: Support as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. Strengths and Difficulties Questionnaire (child reported)

    Five outcomes will be measured using the 30-item Strengths and Difficulties Questionnaire including impact supplement: conduct problems using the conduct problem subscale (5 items); inattention difficulties using the hyperactivity/inattention subscale (5 items); emotional difficulties using the emotional symptoms subscale (5 items); difficulties with peers using the peer relationship problems scale (5 items). Each item is rated on a 3-point scale: Not True = 0, Somewhat True = 1, and Certainly True = 2. For each subscale, scores range from 0 to 10, with higher scores reflecting more difficulties.

    The impact supplement asks participants whether they experience difficulties in emotions, behaviour, concentration, or relationships rated from 'no' to 'severe difficulties'. Further questions ask about interference of these difficulties in areas of life including home, friendships, learning and leisure, rated from 'not at all' to 'a great deal'.

    Measured: Completed at baseline and six months post-baseline.

  2. Emotion Awareness Questionnaire (child reported)

    Two outcomes will be measured to assess mentalizing using two subscales (10 items) of the Emotion Awareness Questionnaire:

    1. Analyses of emotions (5 items, score 5-15) (sample item: "When I am angry or upset, I try to understand why").
    2. Attending to others' emotions (5 items, score 5-15) (sample item: "It is important to know how my friends are feeling").

    For items in both subscales, responses are scored on a three-point scale from 1 (not true) to 3 (often true).

    Measured: Completed at baseline and six months post-baseline.

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

    One family outcome will be measured using the total score of the SCORE-15, a 15-item self-report measure designed to assess perceived family functioning across emotional, behavioral, and communication areas. Participants are asked to indicate how well each statement describes their family using a 5-point scale between the range: 1 (Describes us: Very well) to 5 (Describes us: Not at all).

    In addition to the 15-item quantitative scale, the SCORE-15 includes two open-ended, qualitative questions i.e. "What words would best describe your family?" and "What is the problem/challenge that brought you to therapy?".

    Lastly, the SCORE-15 includes three single-item visual analogue scales designed to capture subjective ratings of severity of difficulties (scale of 0 [No problem at all] to 10 [Really bad]), family managing (scale of 0 [very well] to 10 [very badly]), and perceived helpfulness of therapy (scale of 0 [very helpful] to 10 [unhelpful]).

    Measured: Completed at baseline and six months post-baseline.

  4. Reactive and Proactive Aggression Questionnaire (parent/carer reported)

    One outcome, aggression and violent behaviour, will be measured using a parent/carer version of the RPQ. The RPQ is a 23-item self-report questionnaire designed to assess two subtypes of aggressive behaviour: reactive aggression (12 items) and proactive aggression (11 items). Each item is rated on a 3-point scale indicating frequency of behaviour (0 = Never, 1 = Sometimes, 2 = Often). Subscales range from 0-24 (reactive) and 0-22 (proactive). The total aggression score ranges from 0-46.

    Measured: Completed at baseline and six months post-baseline.

  5. Strengths and Difficulties Questionnaire (parent/carer reported)

    Five outcomes will be measured using the 30-item parent version of the Strengths and Difficulties Questionnaire including impact supplement: conduct problems using the conduct problem subscale (5 items); inattention difficulties using the hyperactivity/inattention subscale (5 items); emotional difficulties using the emotional symptoms subscale (5 items); difficulties with peers using the peer relationship problems scale (5 items). Each item is rated on a 3-point scale: Not True = 0, Somewhat True = 1, and Certainly True = 2. For each subscale, scores range from 0 to 10, with higher scores reflecting more difficulties.

    The impact supplement asks participants whether their child experiences difficulties in emotions, behaviour, concentration, or relationships rated from 'no' to 'severe difficulties'. Further questions ask about interference of these difficulties in areas of life including home, friendships, learning and leisure, rated from 'not at all' to 'a great deal'.

    Measured: Completed at baseline and six months post-baseline.

  6. Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (parent/carer reported)

    One family outcome will be measured using the total score of the SCORE-15 as reported by parents/carers. SCORE-15 is a 15-item self-report measure designed to assess perceived family functioning across emotional, behavioural, and communication areas. Participants are asked to indicate how well each statement describes their family using a 5-point scale between the range: 1 (Describes us: Very well) to 5 (Describes us: Not at all).

    In addition to the 15-item quantitative scale, the SCORE-15 includes two open-ended, qualitative questions i.e. "What words would best describe your family?" and "What is the problem/challenge that brought you to therapy?".

    Lastly, the SCORE-15 includes three single-item visual analogue scales designed to capture subjective ratings of severity of difficulties (scale of 0 [No problem at all] to 10 [Really bad]), family managing (scale of 0 [very well] to 10 [very badly]), and perceived helpfulness of therapy (scale of 0 [very helpful] to 10 [unhelpful]).

    Measured: Completed at baseline and six months post-baseline.

  7. Health of the Nation Outcome Scales for Children and Adolescents (clinician reported)

    Six child outcomes will be measured using six items of the Health of the Nation Outcomes Scales for Children and Adolescents (HoNOSCA) reported by a clinician:

    Disruptive, antisocial or aggressive behaviour; Non accidental self-injury; Substance misuse; Peer relationships; Family life and relationships; School attendance.

    Each item is scored from 0 (no problem) to 4 (severe to very severe problem), with higher scores indicating greater severity. A score of 3 or above on any item indicates a moderate to severe problem.

    Measured: Completed at baseline and six months post-baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start3 Dec 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
632 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091721
Sponsor's protocol ID
MBTCD01
Acronym
MICA
Status last verified
May 2026
First submitted
14 Jul 2025
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36434148
  • 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.

    PubMed 34215323

Questions about this trial

What is this clinical trial studying?

A study testing Mentalization based therapy (MBT) and Support as usual in people with Conduct Disorder and Mentalization Based Therapy, run by Anna Freud at 8 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reactive and Proactive Aggression Questionnaire (child reported) (time frame: Completed at baseline and six months post-baseline (primary endpoint).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07091721, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in