Co-Producing LGBTQ-Affirmative DBT Protocols.

NCT06966193 | Not Yet Recruiting

• 2 other identifiers: 1072NIHR304071
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aims:

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

Conditions

Self-Harm; Suicidal; Emotional Dysregulation

Keywords

LGBTQ+; DBT; Self-Harm; Suicidal Behaviours; Emotion Dysregulation; Young People; Sexual Minorities; Gender Minorities; Co-Production; Adolescents; Therapists

Outcome Measures

Primary Outcomes (11)

• 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).

  Baseline

• Feasibility/Attrition

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

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

• 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.

  For the duration of the focus groups (12 weeks)

• 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?

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

• 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.

  End of Study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

• 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?

  End of study (12 weeks post baseline)

Secondary Outcomes (8)

• Wellbeing

  End of study (12 weeks post baseline)

• Co-Production Process/Respect

  End of study (12 weeks post baseline)

• Co-Production Process/Support

  End of study (12 weeks post baseline)

• Co-production Process/Transparency

  End of study (12 weeks post baseline)

• Co-Production Process/Responsiveness

  End of study (12 weeks post baseline)

Study Arms (3)

DBT Cohort Young Person Sample 1

Six 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 2

Six 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 Sample

Four 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.

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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);

You may not qualify if:

• Non-DBT Cohort Young Person Sample 2
• 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).
• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jake Camp, DClinPsy, MSc, BSc (Hons).

CONTACT

020 7848 0002; Jake.camp@kcl.ac.uk

Patrick Smith, PhD, MSc, BSc

CONTACT

020 7848 0002; Patrick.smith@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Senior Lecturer

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share