NCT05220436

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 13, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

October 13, 2021

Results QC Date

August 23, 2023

Last Update Submit

April 11, 2024

Conditions

Keywords

CARE LEAVERSLOOKED AFTER CHILDRENPSYCHOLOGICAL INTERVENTIONWORKSHOP PROGRAMMEADAPTATIONCOGNITIVE BEHAVIOUR THERAPYACCEPTANCE AND COMMITMENT THERAPY

Outcome Measures

Primary Outcomes (3)

  • 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: 7 months

  • 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: 7 months

  • Participant Feedback About Experience of the Programme (Acceptability)

    Anonymous workshop feedback survey Semi-structured interview to gather participants' qualitative feedback about the programme

    At the end of the workshop day and during closing follow-up one-to-one meeting with DISCOVER team: 2 months later

Secondary Outcomes (4)

  • Mood and Feelings Questionnaire (Angold et al., 1995)

    CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)

  • The Screen for Child Anxiety Related Disorders (Birmaher et al, 1999)

    CHANGE MEASURE: Pre- and post-workshop 1:1 meetings (Baseline - 2 months after workshop day)

  • Child & Adolescent Mindfulness Measure (Greco et al., 2011)

    CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)

  • Warwick & Edinburgh Mental Well-Being Scale (Tennant et al., 2007)

    CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)

Study Arms (1)

DISCOVER workshop programme

EXPERIMENTAL

As this is a case series study, all participants will receive the intervention (i.e. no other arms to the study design). The DISCOVER workshop programme includes: 1:1 mental health and emotional well-being assessment session with a Clinical Psychologist, a group workshop day, follow-up supportive phone calls and a closing follow-up 1:1 mental health and emotional well-being session with a Clinical Psychologist.

Other: DISCOVER workshop programme

Interventions

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

Also known as: DISCOVER "Getting the Life You Want"
DISCOVER workshop programme

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

16+ Care Leavers Service, Medway Children's Services

Chatham, ME4 4TR, United Kingdom

Location

South London & Maudsley NHS Foundation Trust

London, BR3 3BX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Stress, PsychologicalEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Results Point of Contact

Title
Dr Emilie Bourke
Organization
South London & Maudsley NHS Foundation Trust

Study Officials

  • Irene Sclare, DClinPsy

    NHS DISCOVER Team, South London & Maudsley NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

February 2, 2022

Study Start

July 7, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations