Face It Evaluation

Violence Clinical Trial

Official title:

Face It Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062732
• Other study ID #: 2023052
• Status: Recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: The Behavioural Insights Team
• Contact: Tom McBride, MA
• Phone: +44 7989 537 673
• Email: tom.mcbride[@]bi.team
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Emotional Adjustment
• Violence

Intervention

Behavioral:
• Face It
School-based intervention 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.
• Control
Services as usual

Locations

Country	Name	City	State
United Kingdom	Graveney School	London
United Kingdom	Harris Academy Crystal Palace	London

Sponsors (3)

Lead Sponsor	Collaborator
The Behavioural Insights Team	Khulisa, Youth Endowment Fund

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural difficulties	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).	Within 1 month after the end of the intervention
Secondary	Behavioural difficulties	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).	Within 3 months after the end of the intervention
Secondary	Behavioural difficulties	Strengths and Difficulties Questionnaire (SDQ) - parent 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).	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Offending	The Self-Report Delinquency Scale - young person self-report; Variety of delinquency score: Sum the number of items the respondent answers 'yes' to: Yes = 1; No = 0 Produces a score that ranges from 0-19, where a higher score indicates a higher variety of delinquency.; Volume of delinquency score: Summing the point values when respondents report a number of times. Point values are assigned as follows: Once = 1; Twice = 2; 3 times = 3; 4 times = 4; 5 times = 5; Between 6 and 10 times = 6; More than 10 times = 11 Produces a score that ranges from 0 to 11 for each delinquent behaviour, where a higher score indicates a higher volume of delinquency	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Victimisation	The Problem Behaviour Frequency Scale (Overt victimisation and relational victimisation subscales); Produces a score ranging from 6-36 achieved by summing scores of the two subscales, where a higher score indicates a higher frequency of problem behaviours	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Resilience	The Children's Hope Scale; Produces a score ranging from 6-36 where a higher score indicates a higher level of hope.	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Emotional Regulation	The Emotional Regulation Questionnaire; Produces a score ranging from 10-50, where the higher the score, the greater the use of emotion regulation strategies; lower scores represent less frequent use of such strategies	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Social and emotional wellbeing	The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS); Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing	Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Secondary	Average school attendance	Average pupil attendance in the previous three months, recorded as a percentage	Within 3 months after the end of the intervention
Secondary	Number of school exclusions	Number of exclusions over the previous three months	Within 3 months after the end of the intervention