Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-29 @ 6:23 AM
Study NCT ID:
NCT06062732
Status:
UNKNOWN
Last Update Posted:
2023-10-02
First Post:
2023-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Face It Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-14', 'size': 5665067, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-22T09:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioural difficulties', 'timeFrame': 'Within 1 month after the end of the intervention', 'description': 'Strengths and Difficulties Questionnaire (SDQ) - young person self-report\n\nThe 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.\n\nWhile 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).'}], 'secondaryOutcomes': [{'measure': 'Behavioural difficulties', 'timeFrame': 'Within 3 months after the end of the intervention', 'description': 'Strengths and Difficulties Questionnaire (SDQ) - young person self-report\n\nThe 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.\n\nWhile 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).'}, {'measure': 'Behavioural difficulties', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': 'Strengths and Difficulties Questionnaire (SDQ) - parent report\n\nThe 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.\n\nWhile 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).'}, {'measure': 'Offending', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': "The Self-Report Delinquency Scale - young person self-report\n\nVariety of delinquency score:\n\nSum the number of items the respondent answers 'yes' to:\n\n* Yes = 1\n* No = 0 Produces a score that ranges from 0-19, where a higher score indicates a higher variety of delinquency.\n\nVolume of delinquency score:\n\nSumming the point values when respondents report a number of times. Point values are assigned as follows:\n\n* Once = 1\n* Twice = 2\n* 3 times = 3\n* 4 times = 4\n* 5 times = 5\n* Between 6 and 10 times = 6\n* 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"}, {'measure': 'Victimisation', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': 'The Problem Behaviour Frequency Scale (Overt victimisation and relational victimisation subscales)\n\nProduces 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'}, {'measure': 'Resilience', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': "The Children's Hope Scale\n\nProduces a score ranging from 6-36 where a higher score indicates a higher level of hope."}, {'measure': 'Emotional Regulation', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': 'The Emotional Regulation Questionnaire\n\nProduces 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'}, {'measure': 'Social and emotional wellbeing', 'timeFrame': 'Within 1 month after the end of the intervention and within 3 months after the end of the intervention', 'description': 'The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)\n\nScores range from 7 to 35 and higher scores indicate higher positive mental wellbeing'}, {'measure': 'Average school attendance', 'timeFrame': 'Within 3 months after the end of the intervention', 'description': 'Average pupil attendance in the previous three months, recorded as a percentage'}, {'measure': 'Number of school exclusions', 'timeFrame': 'Within 3 months after the end of the intervention', 'description': 'Number of exclusions over the previous three months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['young people', 'school exclusion', 'youth violence', 'social and emotional skills'], 'conditions': ['Violence', 'Emotional Adjustment']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': "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.\n\nThere 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.\n\nThe 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.\n\nHowever, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in years 9-10\n* Students who speak functional English\n* Students who are willing to take part in the programme\n* Students who have experienced relational or social adversity\n* Students who have disengaged from education\n\nExclusion Criteria:\n\n* Students who are permanently excluded or not in full-time mainstream education\n* Students with SEND who receive 1 to 1 support\n* Students with active, severe and unaddressed safeguarding or mental health risk(s)\n* Students who are actively receiving mental health support'}, 'identificationModule': {'nctId': 'NCT06062732', 'briefTitle': 'Face It Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'The Behavioural Insights Team'}, 'officialTitle': 'Face It Evaluation', 'orgStudyIdInfo': {'id': '2023052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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', 'interventionNames': ['Behavioral: Face It']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Services as usual', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Face It', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Services as usual', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE19 2JH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Johnathan Barnes, BA', 'role': 'CONTACT', 'email': 'barnesj@harriscrystalpalace.org.uk', 'phone': '020 8771 2261'}], 'facility': 'Harris Academy Crystal Palace', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 9BU', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Simbi Wickliffe, BSc, PGCSE', 'role': 'CONTACT', 'email': 'swickliffe@graveney.wandsworth.sch.uk', 'phone': '020 8682 7000'}], 'facility': 'Graveney School', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Tom McBride, MA', 'role': 'CONTACT', 'email': 'tom.mcbride@bi.team', 'phone': '+44 7989 537 673'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared with YEF within 6 months after submission of the final report to YEF.', 'ipdSharing': 'YES', 'description': 'After the project has been completed, data will be shared with YEF and stored in the YEF archives.\n\nApproved 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.', 'accessCriteria': 'Researchers who are approved by the YEF and accredited to work with ONS data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Behavioural Insights Team', 'class': 'OTHER'}, 'collaborators': [{'name': 'Youth Endowment Fund', 'class': 'UNKNOWN'}, {'name': 'Khulisa', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Tom McBride', 'investigatorAffiliation': 'The Behavioural Insights Team'}}}}