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临床试验/NCT06062732
NCT06062732招募中不适用

Face It Evaluation

The Behavioural Insights Team4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
4
主要终点
Behavioural difficulties

研究概览

简要总结

This project is a pilot evaluation randomised controlled trial of Face It, a school-based intervention designed and implemented by Khulisa. Face It is specifically designed for young people at risk of offending, exploitation and school exclusion. The programme builds self-awareness and encourages pupils to reflect on the root causes and triggers of their disruptive or challenging behaviour. Khulisa believes that early intervention breaks the school to prison pipeline, which is exacerbated by exclusion, enabling young people to choose a safe and crime-free future. The intervention is delivered over 6 weeks, including an intensive 5-day programme of activities, and pre-programme and post-programme group and 1:1 sessions. Each programme is tailored to participants' needs and uses art, storytelling, 1:1 and group experiential techniques, delivered by trained dramatherapists.

The randomised controlled trial will test the programme's feasibility, acceptability, evaluability, mechanisms and outcomes, to determine whether the trial should proceed to a full-scale efficacy trial through quantitative and qualitative data collection.

详细描述

Face It is a schools-based intervention, developed by Khulisa. It is an intensive therapeutic group programme for young people, focused on developing social and emotional skills and designed to explore the root causes of emotional distress. It combines creative techniques like storytelling, art, debating, and role-play, informed by neuroscience.

There is strong evidence that social and emotional skills are important for the positive development of children and young people, and contribute to a range of important long-term educational, economic, health, social and criminal justice outcomes. There is also good evidence that well-designed school-based social and emotional programmes can be effective, that they are being successfully implemented in UK schools, and can have positive impact on students' social and emotional competencies and educational outcomes.

The Face It intervention is in its early stages in terms of evidence and evaluation, and there is not yet a robust randomised control trial demonstrating that it is effective at improving outcomes for children and young people. However, Face It indicates early promise as an intervention to improve social and emotional skills. The intervention has demonstrated that it can recruit and retain participants, and qualitative work indicates that the programme is well-regarded by participants. An internal evaluation of the programme conducted by Nesta indicated that Khulisa's theory of change highlights relevant outcomes, and both quantitative and qualitative insights suggested largely positive changes in the outcomes examined. Khulisa is also currently conducting a quasi-experimental study which is scheduled to be completed in the Autumn 2023. These studies collectively show that the intervention shows promise.

However, the lack of a randomised comparison group in the existing evaluations limits the conclusions that can be made about impact on outcomes for children and young people. Before any future full-scale randomised control trial, it is important that a small-scale pilot trial is conducted in advance to support and inform this work - to test and improve evaluation procedures such as randomisation and data collection, and to generate useful information around sample size determination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Baseline and post-treatment assessment will be conducted by researchers who are blind to treatment allocation. Young people, teachers and families are not blind to treatment allocation.

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students in years 9-10
  • Students who speak functional English
  • Students who are willing to take part in the programme
  • Students who have experienced relational or social adversity
  • Students who have disengaged from education

排除标准

  • Students who are permanently excluded or not in full-time mainstream education
  • Students with SEND who receive 1 to 1 support
  • Students with active, severe and unaddressed safeguarding or mental health risk(s)
  • Students who are actively receiving mental health support

结局指标

主要结局

Behavioural difficulties

时间窗: Within 1 month after the end of the intervention

Strengths and Difficulties Questionnaire (SDQ) - young person self-report The overall (five-subscale) SDQ score ranges from 0 to 50, with a higher score indicating abnormal behaviours. The Total Difficulties score ranges from 0 to 40. The externalising score ranges from 0 to 20 and is the sum of the conduct and hyperactivity scales. The internalising score ranges from 0 to 20 and is the sum of the emotional and peer problems scales. Higher scores indicate abnormal behaviours. While the total difficulties score is the primary outcome, we will also examine the total difficulties score when broken down into the externalising score (the sum of the conduct and hyperactivity scales), and the internalising score (the sum of the emotional and peer problems scales).

次要结局

  • Resilience(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)
  • Number of school exclusions(Within 3 months after the end of the intervention)
  • Behavioural difficulties(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)
  • Average school attendance(Within 3 months after the end of the intervention)
  • Offending(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)
  • Victimisation(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)
  • Emotional Regulation(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)
  • Social and emotional wellbeing(Within 1 month after the end of the intervention and within 3 months after the end of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom McBride

Director

The Behavioural Insights Team

研究点 (4)

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