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

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)

Overview

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.

Interventions

• Behavioral Mentalization based therapy (MBT)
  Mentalization based therapy for conduct disorder
• Other Support as usual
  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

Primary outcome measures

• Reactive and Proactive Aggression Questionnaire (child reported) [Time frame: Completed at baseline and six months post-baseline (primary endpoint).]

Secondary outcome measures (7)

• Strengths and Difficulties Questionnaire (child reported) [Time frame: Completed at baseline and six months post-baseline.]
• Emotion Awareness Questionnaire (child reported) [Time frame: Completed at baseline and six months post-baseline.]
• Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (child reported) [Time frame: Completed at baseline and six months post-baseline.]
• Reactive and Proactive Aggression Questionnaire (parent/carer reported) [Time frame: Completed at baseline and six months post-baseline.]
• Strengths and Difficulties Questionnaire (parent/carer reported) [Time frame: Completed at baseline and six months post-baseline.]
• Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (parent/carer reported) [Time frame: Completed at baseline and six months post-baseline.]
• Health of the Nation Outcome Scales for Children and Adolescents (clinician reported) [Time frame: Completed at baseline and six months post-baseline.]

Eligibility criteria

Inclusion criteria

• 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:

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 8 centers

• Hampshire and Isle of Wight Healthcare NHS Foundation Trust — Southampton
• Yorkshire and Humber FCAMHS, South West Yorkshire Partnership NHS Foundation Trust — Wakefield
• South Central Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust — Headington
• South West (North) Community Forensic CAMHS Team, Oxford Health NHS Foundation Trust — Headington
• The North East and North Cumbria Community Forensic Child & Adolescent Mental Health Servi — Newcastle upon Tyne
• East of England Community FCAMHS Team, Cambridgeshire and Peterborough NHS Foundation Trus — Cambridge
• North London Forensic CAMHS, North London NHS Foundation Trust — London
• South West FCAMHS, Somerset NHS Foundation Trust — Taunton

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. PMID 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. PMID 34215323

Identifiers

NCT: NCT07091721 · MBTCD01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗