ViolenceNCT06062732
Face It Evaluation
A study testing Face It in people with Violence and Emotional Adjustment, run by The Behavioural Insights Team at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Emotional Adjustment
- What is being tested?
- Face It
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Harris Academy Crystal Palace
London, SE19 2JH
Johnathan Barnes, BA, 020 8771 2261, barnesj@harriscrystalpalace.org.uk
- Recruiting
Graveney School
London, SW17 9BU
Simbi Wickliffe, BSc, PGCSE, 020 8682 7000, swickliffe@graveney.wandsworth.sch.uk
About this study
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.
Read the 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.
- Conditions
- Violence, Emotional Adjustment
- Being tested
- Face It, Control
- Keywords
- young people, school exclusion, youth violence, social and emotional skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face ItBehavioural
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.
ControlBehavioural
Services as usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Face It |
| Control | Active comparator | Services as usual Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 1 month after the end of the intervention
Secondary outcomes (9)
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).
Measured: Within 3 months after the end of the intervention
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).
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
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
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
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
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Resilience
The Children's Hope Scale
Produces a score ranging from 6-36 where a higher score indicates a higher level of hope.
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
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
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
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
Measured: Within 1 month after the end of the intervention and within 3 months after the end of the intervention
Average school attendance
Average pupil attendance in the previous three months, recorded as a percentage
Measured: Within 3 months after the end of the intervention
Number of school exclusions
Number of exclusions over the previous three months
Measured: Within 3 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startSep 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Behavioural Insights Team
- Sponsor type
- University, hospital or other
- Collaborators
- Youth Endowment Fund, Khulisa
- Responsible party
- Principal investigator, Tom McBride, The Behavioural Insights Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062732
- Sponsor's protocol ID
- 2023052
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face It Evaluation
- ClinicalTrials.gov ID
- NCT06062732
- Acronym / sponsor ID
- 2023052
- Conditions
- Violence, Emotional Adjustment
- Keywords
- young people, school exclusion, youth violence, social and emotional skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Behavioural Insights TeamUniversity, hospital or other
- Collaborators
- Youth Endowment Fund, Khulisa
- Study start
- Sep 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Face ItFace It programme, including pre-programme one-to-one and group sessions, 5-day intensive programme, and post-programme one-to-one and group sessions |
| Control | Active comparator | Behavioral: ControlServices as usual |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face ItSchool-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. | Behavioural | Intervention |
| ControlServices as usual | Behavioural | Control |
Primary outcome
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).
9 secondary outcomes
Behavioural difficulties
Time frame: 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
Offending
Time frame: 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
Resilience
Time frame: 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
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
Average school attendance
Time frame: Within 3 months after the end of the intervention
Number of school exclusions
Time frame: Within 3 months after the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face It in people with Violence and Emotional Adjustment, run by The Behavioural Insights Team at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom McBride, MA (+44 7989 537 673, tom.mcbride@bi.team), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural difficulties (time frame: Within 1 month after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.