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| Name | Class |
|---|---|
| University of Hertfordshire | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBT | Experimental |
| |
| Support as usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentalization based therapy (MBT) | Behavioral | Mentalization based therapy for conduct disorder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Additional inclusion criteria for participants recruited from a clinician's existing caseload:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hampshire and Isle of Wight Healthcare NHS Foundation Trust | Not yet recruiting | Southampton | Calmore | SO40 2RZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36434148 | Background | 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. | |
| 34215323 | Background | 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. |
| Label | URL |
|---|---|
| The MICA study will be hosted on the Anna Freud Research Library platform. | View source |
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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.
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| Support as usual |
| Other |
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 |
|
| Completed at baseline and six months post-baseline. |
| Emotion Awareness Questionnaire (child reported) | 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). | Completed at baseline and six months post-baseline. |
| 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]). | Completed at baseline and six months post-baseline. |
| 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. | Completed at baseline and six months post-baseline. |
| 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'. | Completed at baseline and six months post-baseline. |
| 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]). | Completed at baseline and six months post-baseline. |
| 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. | Completed at baseline and six months post-baseline. |
| 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) | 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). | 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) |
| Yorkshire and Humber FCAMHS, South West Yorkshire Partnership NHS Foundation Trust | Recruiting | Wakefield | Ouchthorpe Lane | WF1 3SP | United Kingdom |
|
| South Central Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust | Recruiting | Headington | Oxford | OX3 7JX | United Kingdom |
|
| South West (North) Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust | Recruiting | Headington | Oxford | OX3 7JX | United Kingdom |
|
| The North East and North Cumbria Community Forensic Child & Adolescent Mental Health Service, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust | Recruiting | Newcastle upon Tyne | Upon Tyne and Wear | NE3 3XT | United Kingdom |
|
| East of England Community FCAMHS Team, Cambridgeshire and Peterborough NHS Foundation Trust | Not yet recruiting | Cambridge | CB21 5EF | United Kingdom |
|
| North London Forensic CAMHS, North London NHS Foundation Trust | Not yet recruiting | London | NW3 5BA | United Kingdom |
|
| South West FCAMHS, Somerset NHS Foundation Trust | Recruiting | Taunton | TA1 5DA | United Kingdom |
|
| The Youth Endowment Fund (YEF) archive platform will serve as the hosting platform for anonymised data archived from the MICA study. | View source |
| ID | Term |
|---|---|
| D019955 | Conduct Disorder |
| D000374 | Aggression |
| D000294 | Adolescent Behavior |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D000088042 | Mentalization-Based Therapy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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