NCT06062732

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 18, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

young peopleschool exclusionyouth violencesocial and emotional skills

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Behavioural difficulties

    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

  • 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

  • Resilience

    Within 1 month after the end of the intervention and within 3 months after the end of the intervention

  • +4 more secondary outcomes

Study Arms (2)

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

Behavioral: Face It

Control

ACTIVE COMPARATOR

Services as usual

Behavioral: Control

Interventions

Face ItBEHAVIORAL

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.

Intervention
ControlBEHAVIORAL

Services as usual

Control

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harris Academy Crystal Palace

London, SE19 2JH, United Kingdom

RECRUITING

Graveney School

London, SW17 9BU, United Kingdom

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 2, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared with YEF within 6 months after submission of the final report to YEF.
Access Criteria
Researchers who are approved by the YEF and accredited to work with ONS data.

Locations