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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorAnna Freud

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mentalization based therapy (MBT)

    Behavioral

    Mentalization based therapy for conduct disorder

  • Support as usual

    Other intervention

    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

Treatment groups

632 Participants
are divided into 2 treatment groups
Group A: MBTExperimental treatment 1 intervention
Group B: Support as usualActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

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'.

Time frame
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).

Time frame
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 \[unhelpful\]).

Time frame
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.

Time frame
Completed at baseline and six months post-baseline.

Other outcomes

1

Therapeutic alliance (child reported)

Therapeutic alliance, as a potential mediator or mechanism of change, will be assessed in the intervention arm at three timepoints (early therapy e.g. session 1-3, mid-therapy e.g. session 10-13, and late therapy e.g. session 20-24) using the Session Rating Scale (SRS). The SRS assesses the young person's perceptions of: respect and understanding from the clinician, how much they talk about the topics that matter to them, the clinicians approach or method, and overall acceptability of the session. A visual line is presented with contrasting statements at each e.g. "I did not feel heard, understood and respected", versus "I felt heard, understood and respected", (on the SRS version for 6-12 year olds, the statements are supplemented with a sad face or smiley face, respectively). Participants indicate their experience by placing a mark somewhere along the line. Reponses marked closest to the positive version of the statement (the smiley face) indicate a better therapeutic alliance.

Time frame
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)
2

Goal based outcomes (child reported)

Progress towards goals, as a potential mediator or mechanism of change, will be assessed in the intervention arm at three timepoints (early therapy e.g. session 1-3, mid-therapy e.g. session 10-13, and late therapy e.g. session 20-24) using the goal based outcome (GBO) tool. The GBO enables young people to set up to three goals and rate the extent to which they feel that they have reached their goals on a scale of 0 (no progress) to 10 (fully reached).

Time frame
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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Freud

Lead sponsor

University of Hertfordshire

Collaborator