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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 632
- 试验地点
- 19
- 主要终点
- Reactive and Proactive Aggression Questionnaire (child reported)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Support as usual
干预措施: Support as usual (Other)
MBT
干预措施: Mentalization based therapy (MBT) (Behavioral)
结局指标
主要结局
Reactive and Proactive Aggression Questionnaire (child reported)
时间窗: 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.
次要结局
- Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (parent/carer reported)(Completed at baseline and six months post-baseline.)
- Health of the Nation Outcome Scales for Children and Adolescents (clinician reported)(Completed at baseline and six months post-baseline.)
- Strengths and Difficulties Questionnaire (child reported)(Completed at baseline and six months post-baseline.)
- Emotion Awareness Questionnaire (child reported)(Completed at baseline and six months post-baseline.)
- Systemic Clinical Outcome and Routine Evaluation (SCORE-15) (child reported)(Completed at baseline and six months post-baseline.)
- Reactive and Proactive Aggression Questionnaire (parent/carer reported)(Completed at baseline and six months post-baseline.)
- Strengths and Difficulties Questionnaire (parent/carer reported)(Completed at baseline and six months post-baseline.)
研究者
Julian Edbrooke-Childs
Co-Director of Evidence Based Practice Unit
Anna Freud