- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062732
Face It Evaluation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tom McBride, MA
- Phone Number: +44 7989 537 673
- Email: tom.mcbride@bi.team
Study Locations
-
-
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London, United Kingdom, SE19 2JH
- Recruiting
- Harris Academy Crystal Palace
-
Contact:
- Johnathan Barnes, BA
- Phone Number: 020 8771 2261
- Email: barnesj@harriscrystalpalace.org.uk
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London, United Kingdom, SW17 9BU
- Recruiting
- Graveney School
-
Contact:
- Simbi Wickliffe, BSc, PGCSE
- Phone Number: 020 8682 7000
- Email: swickliffe@graveney.wandsworth.sch.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Face It programme, including pre-programme one-to-one and group sessions, 5-day intensive programme, and post-programme one-to-one and group sessions
|
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.
|
|
Active Comparator: Control
Services as usual
|
Services as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioural difficulties
Time Frame: 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). |
Within 1 month after the end of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioural difficulties
Time Frame: Within 3 months 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). |
Within 3 months after the end of the intervention
|
|
Behavioural difficulties
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
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
|
|
Offending
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
The Self-Report Delinquency Scale - young person self-report Variety of delinquency score: Sum the number of items the respondent answers 'yes' to:
Volume of delinquency score: Summing the point values when respondents report a number of times. Point values are assigned as follows:
|
Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
|
Victimisation
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
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
|
|
Resilience
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
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
|
|
Emotional Regulation
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
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
|
|
Social and emotional wellbeing
Time Frame: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
|
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
|
|
Average school attendance
Time Frame: Within 3 months after the end of the intervention
|
Average pupil attendance in the previous three months, recorded as a percentage
|
Within 3 months after the end of the intervention
|
|
Number of school exclusions
Time Frame: Within 3 months after the end of the intervention
|
Number of exclusions over the previous three months
|
Within 3 months after the end of the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
After the project has been completed, data will be shared with YEF and stored in the YEF archives.
Approved researchers may apply to access YEF data via the ONS secure research service. This will be accessed via their own project space created in ONS secure research environment by the ONS. They may apply to the DfE and MoJ to access the linked NPD-PNC data, and if successful it will be made available here to combine with the YEF evaluation data, using the PMRs. Researchers will only be able to access pseudonymised data. All results will be published in a deidentified form.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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