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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05220436
Other study ID # 303093
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date September 2022

Study information

Verified date February 2022
Source South London and Maudsley NHS Foundation Trust
Contact Emilie Bourke, DClinPsy
Phone 07702686322
Email emilie.bourke@slam.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The NHS DISCOVER team has secured 2-year funding from the Maudsley Charity to tailor the workshop programme the investigators deliver in school Sixth Forms to meet the specific needs of Care Experienced young people. The investigators are planning to complete a pilot of this adapted workshop programme within Medway Children's Social Services to explore its feasibility, accessibility, acceptability and early-stage efficacy within this population of adolescents. Investigators from the DISCOVER team will recruit young people aged 16-19yrs who are currently known to the Medway Care Leavers 16+ teams. The study will be conducted at Medway Local Authority sites, with the option of some stages being completed remotely via Microsoft Teams if needed in the context of the ongoing COVID-19 pandemic.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 19 Years
Eligibility Inclusion Criteria: Participants who are eligible to take part in this DISCOVER research project will be: - Young people aged 16-19 years who have experience of being in Care and are currently under one of the Medway Children's Social Care, Care Leavers 16+ teams. This means that they are either currently a Looked After young person or a Care Leaver (i.e. they are no longer Looked After but they remain under the care of a Medway Care Leavers team). - Able to work within a group setting over the course of a day workshop. - Able to communicate and read in English. Exclusion Criteria: The investigators will not be able to recruit young people to the project if they are: - Acutely psychotic or actively suicidal. - Currently taking part in other research project(s). - Under the influence of alcohol or any other substances during DISCOVER programme meetings - this is essential as a safety consideration for all participants and staff. Struggles with alcohol/substance use in themselves are not necessarily grounds for exclusion; the investigators will discuss with the allocated member of the young person's Care Leavers 16+ team on a case-by-case basis where relevant. - Unable to communicate and read in English - as the investigators are at an early stage in developing this DISCOVER workshop programme for Care Experienced young people, these young people must be excluded at this time. However, the investigators are eager to review this criterion in future to enhance the accessibility of the intervention, once the initial feasibility and acceptability of the workshop programme has been established.

Study Design


Intervention

Other:
DISCOVER workshop programme
See arm description. The manualised group workshop day is informed by Cognitive Behaviour Therapy and Acceptance & Commitment Therapy principles.

Locations

Country Name City State
United Kingdom 16+ Care Leavers Service, Medway Children's Services Chatham
United Kingdom South London & Maudsley NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
South London and Maudsley NHS Foundation Trust Medway Children's Services

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant uptake (Feasibility & acceptability) Number of young people who come forward for and ultimately take part in the new DISCOVER workshop programme From outset of recruitment, through to final study completion: 10 months
Primary Participant retention (Feasibility & acceptability) Number of young people who remain in the study throughout all stages of the programme From outset of recruitment, through to final study completion: 10 months
Primary Participant feedback about experience of the programme (Acceptability) DISCOVER semi-structured interview to gather participants' qualitative feedback about the programme During closing follow-up one-to-one meeting with DISCOVER team: 2 months after workshop day
Secondary Mood and Feelings Questionnaire (Angold et al., 1995) Depression/low mood symptoms (self-report) - Scores range from 0-66 - higher score indicates higher level of depression symptoms CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)
Secondary The Screen for Child Anxiety Related Disorders (Birmaher et al, 1999) Anxiety symptoms (self-report) - Scores range from 0-82 - higher score indicates higher level of anxiety CHANGE MEASURE: Pre- and post-workshop 1:1 meetings (Baseline - 2 months after workshop day)
Secondary Child & Adolescent Mindfulness Measure (Greco et al., 2011) Capacity for mindfulness (self-report) - Scores range from 0-40 - higher score indicates higher level of mindfulness (after reverse scoring) CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)
Secondary Warwick & Edinburgh Mental Well-Being Scale (Tennant et al., 2007) Emotional well-being and resilience (self-report) - Scores range from 14-70 - higher score indicates greater positive mental wellbeing CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)
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