Mentalization based therapy (MBT)
BehavioralMentalization based therapy for conduct disorder
NCT Number: NCT07091721
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.
Interested in participating?
Request Info10 year–17 year
All sexes
Interventional
Not applicable
Hampshire and Isle of Wight Healthcare NHS Foundation Trust, Southampton, Calmore, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional inclusion criteria for participants recruited from a clinician's existing caseload:
Exclusion criteria
Mentalization based therapy for conduct disorder
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
Time frame: Completed at baseline and six months post-baseline (primary endpoint).
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.
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.
Two outcomes will be measured to assess mentalizing using two subscales (10 items) of the Emotion Awareness Questionnaire:
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.
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.
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.
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'.
Time frame: Completed at baseline and six months post-baseline.
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]).
Time frame: Completed at baseline and six months post-baseline.
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.
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)
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)
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).
Anna Freud
Other
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)
Acronym: MICA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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