Mental Health IssueNCT05220436

DISCOVER Workshop Programme for Care Experienced Young People

A study testing DISCOVER workshop programme in people with Mental Health Issue and Emotional Stress, run by South London and Maudsley NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Mental Health Issue, Emotional Stress, Emotional Regulation
What is being tested?: DISCOVER workshop programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited Kingdom
Study dates: 7 Jul 2022to 1 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

16+ Care Leavers Service, Medway Children's Services
Chatham, ME4 4TR
South London & Maudsley NHS Foundation Trust
London, BR3 3BX

Other trials in United Kingdom

About this study

Official title: DISCOVER "Getting the Life You Want" Workshop Programme for Care Experienced Young People Aged 16-19: A Feasibility and Acceptability Pilot Study

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.

Conditions: Mental Health Issue, Emotional Stress, Emotional Regulation
Being tested: DISCOVER workshop programme
Keywords: CARE LEAVERS, LOOKED AFTER CHILDREN, PSYCHOLOGICAL INTERVENTION, WORKSHOP PROGRAMME, ADAPTATION, COGNITIVE BEHAVIOUR THERAPY, ACCEPTANCE AND COMMITMENT THERAPY
Medical subject headings: Stress, Psychological, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DISCOVER workshop programmeOther
Also called DISCOVER "Getting the Life You Want"
See arm description. The manualised group workshop day is informed by Cognitive Behaviour Therapy and Acceptance \& Commitment Therapy principles.

Study groups in NCT05220436
Study group	Role	What they receive
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. Receives: Other: DISCOVER workshop programme

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant Uptake (Feasibility & Acceptability)
Number of young people who come forward for and ultimately take part in the new DISCOVER workshop programme
Measured: 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
Measured: 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
Measured: 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)
Depression/low mood symptoms (self-report) - Scores range from 0-66 - higher score indicates higher level of depression symptoms
Measured: 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)
Anxiety symptoms (self-report) - Scores range from 0-82 - higher score indicates higher level of anxiety
Measured: CHANGE MEASURE: Pre- and post-workshop 1:1 meetings (Baseline - 2 months after workshop day)
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)
Measured: 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)
Emotional well-being and resilience (self-report) - Scores range from 14-70 - higher score indicates greater positive mental wellbeing
Measured: CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 20221 Mar 2023

First posted2 Feb 2022
Study start7 Jul 2022
Primary completion1 Mar 2023
Study completion1 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental Health IssueStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Case series
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05220436
Sponsor's protocol ID: 303093
Status last verified: Apr 2024
First submitted: 13 Oct 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DISCOVER "Getting the Life You Want" Workshop Programme for Care Experienced Young People Aged 16-19: A Feasibility and Acceptability Pilot Study
ClinicalTrials.gov ID: NCT05220436
Acronym / sponsor ID: 303093
Conditions: Mental Health Issue, Emotional Stress, Emotional Regulation
Keywords: CARE LEAVERS, LOOKED AFTER CHILDREN, PSYCHOLOGICAL INTERVENTION, WORKSHOP PROGRAMME, ADAPTATION, COGNITIVE BEHAVIOUR THERAPY, ACCEPTANCE AND COMMITMENT THERAPY
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: South London and Maudsley NHS Foundation TrustUniversity, hospital or other
Collaborators: Medway Children's Services
Study start: 7 Jul 2022 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 2 Feb 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Case series

Arm	Type	Receives
DISCOVER workshop programme	Experimental	Other: DISCOVER workshop programmeAs 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.

Who may qualify

Ages: 16 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

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
DISCOVER workshop programmeAlso: DISCOVER "Getting the Life You Want"See arm description. The manualised group workshop day is informed by Cognitive Behaviour Therapy and Acceptance \& Commitment Therapy principles.	Other	DISCOVER workshop programme

Primary outcome

Participant Uptake (Feasibility & Acceptability)
Time frame: From outset of recruitment, through to final study completion: 7 months
Number of young people who come forward for and ultimately take part in the new DISCOVER workshop programme
Participant Retention (Feasibility & Acceptability)
Time frame: From outset of recruitment, through to final study completion: 7 months
Number of young people who remain in the study throughout all stages of the programme
Participant Feedback About Experience of the Programme (Acceptability)
Time frame: At the end of the workshop day and during closing follow-up one-to-one meeting with DISCOVER team: 2 months later
Anonymous workshop feedback survey Semi-structured interview to gather participants' qualitative feedback about the programme

4 secondary outcomes

Mood and Feelings Questionnaire (Angold et al., 1995)
Time frame: 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)
Time frame: CHANGE MEASURE: Pre- and post-workshop 1:1 meetings (Baseline - 2 months after workshop day)
Child & Adolescent Mindfulness Measure (Greco et al., 2011)
Time frame: 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)
Time frame: CHANGE MEASURE: Pre-workshop and follow-up one-to-one meetings (Baseline - 2 months after workshop day)

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DISCOVER Workshop Programme	10	7

Primary outcome: Participant Uptake (Feasibility & Acceptability)

Time frame: From outset of recruitment, through to final study completion: 7 months. Count of participants. Unit: Participants

Measure	DISCOVER Workshop Programme n = 10
Value	10

Population analysed: 10 Care Experienced young peopled aged 16-19yrs consented to take part in the DISCOVER GtLYW study.

Primary outcome: Participant Retention (Feasibility & Acceptability)

Time frame: From outset of recruitment, through to final study completion: 7 months. Count of participants. Unit: Participants

Measure	DISCOVER Workshop Programme n = 10
Value	7

Population analysed: Seven 16-19yr old Care Experienced young people completed the full workshop programme.

Primary outcome: Participant Feedback About Experience of the Programme (Acceptability)

Time frame: At the end of the workshop day and during closing follow-up one-to-one meeting with DISCOVER team: 2 months later. Count of participants. Unit: Participants

Measure	DISCOVER Workshop Programme n = 7
No. young people who rated the quality of the DISCOVER service on the workshop day as excellent/good	7
No. young people who reported that they were satisfied with the DISCOVER service on the workshop day	7
No. young people who reported that they felt that they got the help they wanted on the workshop day.	7
No. young people who rated that 'all' or 'most' of their needs had been met on the workshop day.	7
No. young people reported that they would recommend the workshop to a friend.	7

Population analysed: Young people who attended were asked to provide anonymised feedback at the end of their DISCOVER workshop day. Their qualitative feedback response were gathered during the final 1:1 DISCOVER meeting at the end of the programme.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The full study lasted between 03/01/2022 - 31/03/2023. Each young person's journey through the study lasted 2-3 months, depending on when they were available for their closing DISCOVER 1:1 meeting at the end of the programme.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DISCOVER Workshop Programme	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Our funder - Maudsley Charity - summarise the planned project on their websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Irene Sclare, DClinPsy principal investigator

NHS DISCOVER Team, South London & Maudsley NHS Foundation Trust

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DISCOVER workshop programme in people with Mental Health Issue and Emotional Stress, run by South London and Maudsley NHS Foundation Trust 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Uptake (Feasibility & Acceptability) (time frame: From outset of recruitment, through to final study completion: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220436.

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 19 Sep 2024.