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Self-HarmNCT06966193

Co-Producing LGBTQ-Affirmative DBT Protocols.

An observational study of Self-Harm and Suicidal, run by King's College London at 1 site 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

Aims: 1. To co-produce new intervention parts that meet the needs of LGBTQ+ people at risk of self-harm or suicidal thoughts, with LGBTQ+ people and DBT therapists. These intervention parts will be integrated into a Dialectical Behaviour Therapy (DBT) intervention, that is provided earlier in a persons mental health… Read more about this study

Who is it for?
Ages 13 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Self-Harm, Suicidal, Emotional Dysregulation
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2025to 30 May 2026
Phase
Observational
Are there results?
None posted in the registry

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 13 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: DBT Cohort Young Person Sample 1 Young people will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service and the adult DBT service within South London \& Maudsley NHS Foundation Trust. Non-DBT Cohort Young Person Sample 2 Young people will be recruited from CAMHS within South London \& Maudsley NHS Foundation Trust and from community organisations (e.g. LGBTQ+ charities) and general advertising on social media and similar. DBT Therapists DBT therapists will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service and Adult DBT Services in South London \& Maudsley NHS Foundation Trust.

Who may be able to join

  • Is aged 13 to 21 years old;
  • has completed at least four months of comprehensive DBT (i.e. inclusive of all four modes of intervention; Linehan, 1993; Miller et al., 2006; Rathus \& Miller, 2015) in the past 24 months or have completed at least four months of DBT and are still in a comprehensive DBT programme;
  • identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity);
  • is willing and able to participate in the study. While no specific inclusion or exclusion criteria will be placed on other variables, typically to be eligible for a DBT programme, young people would need to have a history of self-harm and/or suicidal behaviours, difficulties with emotion regulation, and potentially difficulties with the remaining symptom list within borderline/emotionally unstable personality disorder. Recruitment size is based on PPI recommendations regarding effective group sizes, with allowances for sample attrition.
  • Non-DBT Cohort Young Person Sample 2
  • Inclusion criteria will follow similar to sample 1. The young person:
Show all 16Show fewer
  • Is aged 13 to 21 years old;
  • has not accessed and is not currently enrolled in a comprehensive DBT programme;
  • has experienced difficulties with LGBTQ-related identity confusion, managing stigma experiences, and connecting with similar others;
  • identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity);
  • is willing and able to participate in the study (i.e. are based in the UK and can attend the in-person and online groups).
  • No other inclusion or exclusion criteria will be systematically implemented for this group.
  • DBT Therapist Sample
  • Currently practicing or having completed (or recently finished, within the past 12 months) a comprehensive DBT programme as a DBT therapist. In order to practice as a DBT therapist, they must hold a professional qualification recognised by appropriate healthcare regulators.
  • Having experience working with at least one LGBTQ+ client in DBT, who was aged between 13 and 21 years at the time.
  • Being willing and able to participate in the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • South London & Maudsley NHS Foundation Trust

    London, London, SE5 8AZ

Other trials in United Kingdom

About this study

Official title: Co-Producing LGBTQ-Affirmative Intervention Protocols for LGBTQ+ People at Risk of Self-Harm and Suicide: A Co-Production Study

Aims:

  1. To co-produce new intervention parts that meet the needs of LGBTQ+ people at risk of self-harm or suicidal thoughts, with LGBTQ+ people and DBT therapists. These intervention parts will be integrated into a Dialectical Behaviour Therapy (DBT) intervention, that is provided earlier in a persons mental health care journey, than DBT is usually targeted at.
  2. To assess how acceptable and feasible the co-production process was for participants, and how well it achieved co-production principles (e.g. participants feel supported, that the aims were transparent, etc).
Read more

Why is This Important? Young people who identify as lesbian, gay, bisexual, transgender, queer, and with other minoritised gender and sexual identities (LGBTQ+) are much more likely to self-harm and experience suicidal thoughts than cisgender-heterosexual (non-LGBTQ+) people. They also experience barriers when accessing mental health support. Some of these barriers come from a lack of support tailored towards their needs as an LGBTQ+ person. This often means that things get worse before they access the right support, and so are often seen in higher-intensity interventions (tier 4 or tertiary care), like DBT.

What The Investigators Plan to Do:

The investigators plan to hold some focus groups with three different groups of people to co-produce the new intervention parts. The three groups include:

  1. A group of LGBTQ+ young people (13-21 years old) who have completed a at full DBT programme recently.
  2. A group of LGBTQ+ young people (13-21 years old) who have never been in a full DBT programme but experienced similar difficulties.
  3. A group of DBT therapists who have supported LGBTQ+ young people before.

The investigators will seek feedback from participants about how acceptable they found the study (e.g. how satisfied they were with the process), how feasible it was (e.g. were they able to attend and was it practice?), and how well they stuck to the coproduction principles (e.g. how supported they felt).

Keywords
LGBTQ+, DBT, Self-Harm, Suicidal Behaviours, Emotion Dysregulation, Young People, Sexual Minorities, Gender Minorities, Co-Production, Adolescents, Therapists
Medical subject headings
Self-Injurious Behavior

What participants receive

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

Study groups in NCT06966193
Study groupRoleWhat they receive
DBT Cohort Young Person Sample 1Six to 12 young people who have completed at least four months of DBT, including those who did not complete the entire intended duration of the intervention or those still in the intervention, will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service. If the investigators are unable to recruit sufficient numbers, they will seek to recruit from the adult DBT service within South London \& Maudsley NHS Foundation Trust. Inclusion criteria will include that the young person: 1. Is aged 13 to 21 years old; 2. has completed at least four months of comprehensive DBT (i.e. inclusive of all four modes of intervention; Linehan, 1993; Miller et al., 2006; Rathus \& Miller, 2015) in the past 24 months or have completed at least four months of DBT and are still in a comprehensive DBT programme; 3. identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity); 4. is willing and able to participate in the study.
Non-DBT Cohort Young Person Sample 2Six to 12 young people who have experienced difficulties with at least one of the identified intervention targets (identity confusion, managing stigma experiences, and connecting with similar others) will be recruited from CAMHS and from community organisations (e.g. LGBTQ+ charities). Inclusion criteria will follow similar to sample 1. The young person: 1. Is aged 13 to 21 years old; 2. has not accessed and is not currently enrolled in a comprehensive DBT programme; 3. has experienced difficulties with LGBTQ-related identity confusion, managing stigma experiences, and connecting with similar others; 4. identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity); 5. is willing and able to participate in the study (i.e. are based in the UK and can attend the in-person and online groups).
DBT Therapist SampleFour to eight DBT therapists will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service and Adult DBT Services in South London \& Maudsley NHS Foundation Trust. Inclusion criteria will include: 1. Currently practicing or having completed (or recently finished, within the past 12 months) a comprehensive DBT programme as a DBT therapist. In order to practice as a DBT therapist, they must hold a professional qualification recognised by appropriate healthcare regulators. 2. Having experience working with at least one LGBTQ+ client in DBT, who was aged between 13 and 21 years at the time. 3. Being willing and able to participate in the study.

What is being measured

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

  1. Feasibility/Recruitment

    Whether the investigators are able to recruit the intended numbers of participants to each group by the start of the focus groups (baseline).

    Measured: Baseline

  2. Feasibility/Attrition

    Participant attrition rates at baseline, during the study, and at outcome measure completion (12 weeks from baseline).

    Measured: Baseline, during the focus groups (12 weeks in duration), and at outcome measure completion (12 weeks from baseline)

  3. Feasibility/Focus Group Content and Delivery

    The count frequency of focus groups, individual sessions, and duration of each taken will be recorded. The content of the focus groups will be documented. The number of facilitators of each type will also be documented.

    Measured: For the duration of the focus groups (12 weeks)

  4. Acceptability/Session Satisfaction

    Self-report question at the end of each focus group/individual session: How satisfied were you with the focus group/individual session? [Response Options: Very Satisfied, Satisfied, Neutral, Unsatisfied, Very Unsatisfied].

    [Prompt] Can you tell us why you gave that rating? [Prompt] what would have improved your satisfaction?

    Measured: At the end of each focus group (6 focus groups over 12 weeks)

  5. Acceptability/Satisfaction with the Study

    End of study feedback:

    How satisfied were you with the focus group/individual sessions overall? Response Options: Very Satisfied, Satisfied, Neutral, Unsatisfied, Very Unsatisfied. Prompts to elicit qualitative feedback.

    How satisfied were you with the final version of the intervention protocols that we all produced together? Response Options: Very Satisfied, Satisfied, Neutral, Unsatisfied, Very Unsatisfied. Prompts to elicit qualitative feedback.

    Measured: End of Study (12 weeks post baseline)

  6. Acceptability/Recommend to Others

    End of study feedback:

    Would you recommend this study to other potential LGBTQ+ people if we were to run the study again? [Response Options] Yes, No, Maybe [Prompt] Can you tell us why you gave that rating?

    Measured: End of study (12 weeks post baseline)

  7. Acceptability/Helpfulness

    End of study feedback:

    Did you find participating in this study helpful to you? [Response Options] Yes, No, Maybe [Prompt] Can you tell us why you have that rating? [Prompt] What would have made it more useful?

    Measured: End of study (12 weeks post baseline)

  8. Acceptability/Engagement

    End of study feedback:

    [Acceptability/Engagement.] What helped you to engage in the focus groups?[Acceptability/Engagement.] What got in the way of engaging in the focus groups?

    Measured: End of study (12 weeks post baseline)

  9. Acceptability/Cultural Sensitivity

    End of study Feedback:

    [Acceptability/Cultural Sensitivity.] Did the content of the focus groups feel respectful and relevant for LGBTQ+ culture and potential intersecting cultures within the community? [Response Options] Yes, No, Maybe [Prompt] Can you tell us why you gave that rating? [Prompt] Were there any blind spots in this regard? [Prompt] What could we have done differently to improve respect and relevance? [Prompt] What worked well in this regard?

    Measured: End of study (12 weeks post baseline)

  10. Feasibility/General

    End of study feedback:

    How feasible was it for you to take part in this project? [Prompt] Feasible means how possible it was to do this easily or conveniently. [Response Options] Very Feasible, Feasible, Neither Feasible or Unfeasible, Unfeasible, Very Unfeasible [Prompt] Can you tell us why you gave that rating? [Prompt] What made it more feasible? [Prompt] What were the barriers to it being feasible?

    Measured: End of study (12 weeks post baseline)

  11. Feasibility/Practicalities

    End of study feedback:

    [Feasibility/Practicality.] Can you tell us how you found the practicalities of the workshop, including but not limited to the timings, the environment they were conducted in (online vs in-person), the types of activities used, and so forth? [Prompt] cover any in the list which the participant did not speak to [Prompt] How did this impact the feasibility of taking part, if at all? [Prompt] What would you recommend to improve any future similar studies in regards to practicalities?

    Measured: End of study (12 weeks post baseline)

Secondary outcomes (8)

  1. Wellbeing

    End of study feedback:

    [Wellbeing.] Did taking part in this project have any impact on your wellbeing? This can be positive, negative, or neutral?

    Measured: End of study (12 weeks post baseline)

  2. Co-Production Process/Respect

    My contributions within the whole study felt respected and acknowledged. [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  3. Co-Production Process/Support

    I felt adequately supported within the whole study (e.g. my expenses were covered, I was offered support if needed, my questions were answered, etc).

    [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What made you feel supported? [Prompt] What didn't make you feel supported? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  4. Co-production Process/Transparency

    The aims of the study and of my involvement were clear to me. [Response Options: Very True, True, Neutral, Untrue, Very Untrue] [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  5. Co-Production Process/Responsiveness

    I felt listened to and like my contributions were responded to in the study. [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  6. Co-Production Process/Fairness of Opportunities

    I felt like everyone was given fair opportunities, especially in the context of diversity within the group? [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  7. Co-production Process/Accountability

    I felt accountable for my involvement in the study and was able to provide feedback.

    [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

  8. Co-Production/Empowerment

    Did you feel empowered to take part in the study? [Response Options: Very True, True, Neutral, Untrue, Very Untrue]. [Prompt] Can you tell us why? [Prompt] What worked well? [Prompt] What worked less well? [Prompt] Recommendations for improving this?

    Measured: End of study (12 weeks post baseline)

Timeline

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

  1. First posted11 May 2025
  2. Study start1 Oct 2025
  3. Primary completion30 Apr 2026
  4. Study completion30 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966193
Sponsor's protocol ID
1072
Other IDs
NIHR304071
Status last verified
May 2025
First submitted
24 Apr 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The majority of the data is qualitative and thus would have cause problems with anonymity if IPD was made available.

Questions about this trial

What is this clinical trial studying?

An observational study of Self-Harm and Suicidal, run by King's College London at 1 site 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 16 inclusion and 0 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility/Recruitment (time frame: Baseline). The study lists 11 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 NCT06966193.

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 31 Aug 2026.

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