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Completed

NCT Number: NCT06237608

Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting

Gender diverse (e.g. trans or non-binary) young people are at higher risk of self-harm and may be more likely to access support through gender-diverse-specific 3rd sector charities. Dialectical behavioural therapy (DBT) is a transdiagnostic intervention targeting emotion dysregulation, self-harm and suicidality and is recommended by best-practice clinical guidelines; There is developing evidence that DBT skills training can be offered as an effective stand-alone intervention.The current study, therefore, aims to evaluate the feasibility, acceptability and early indicators of effectiveness of a DBT-informed skills group intervention in a gender diverse charity setting. The intervention will be co-facilitated with a gender-diverse support worker from the charity to develop the therapeutic skills of the charity staff working with the young people, whilst they provide specialist knowledge and valuable lived experience.

Research questions

1. Is the intervention feasible to deliver in a charity setting? 2. Is the intervention acceptable to participants and charity facilitators?

Participants will attend a 16-week group intervention. They will complete questionnaire to assess acceptability at the end of the intervention. Attrition rates, training time, and questionnaires will be used to assess feasibility. Outcome measures will also be completed by the participants every three weeks to indicate possible effectiveness of the intervention. The outcomes will include emotion dysregulation, coping skills, anxiety, depression and suicidal behaviours.

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Key information

Conditions

Emotional Regulation Behavior Self-Control Social Behavior

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE5 8AN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 16-25 years old
  • Identify as gender diverse
  • Receiving support from Gendered Intelligence
  • Support worker identified and self-report emotion regulation difficulties.

Exclusion criteria

  • In acute crisis at point of recruitment and start of the intervention such as active suicidal ideation with active plans, or severe self-harm requiring intensive interventions such as inpatient or crisis care.

Treatment and study plan

Dialectical behavioural therapy (DBT)-informed skills group

Behavioral

16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators

Primary outcomes

  1. Acceptability of intervention

    Time frame: 16 weeks

    • Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.

  2. Acceptability of intervention

    Time frame: 16 weeks

    • Client Satisfaction Questionnaire will be completed post-intervention.

  3. Feasibility of intervention

    Time frame: 16 weeks

    • Eligibility rates at screening

  4. Feasibility of intervention

    Time frame: 16 weeks

    • Attrition rates at each stage of recruitment - initial number of participants identified by Gendered Intelligence, number of participants approached, number of participants who consented to discuss the project with the researcher, number of participants who consented to take part, number of participants who completed treatment.

  5. Feasibility of intervention

    Time frame: 16 weeks

    • Attendance and completion rates of the intervention 4. Cost and time to train a charity support worker 5. Number of clinician hours to deliver the intervention and outcome monitoring 6. Number of hours from charity to deliver the intervention 7. How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  6. Feasibility of intervention

    Time frame: 16 weeks

    • Cost and time to train a charity support worker

  7. Feasibility of intervention

    Time frame: 16 weeks

    • Number of clinician hours to deliver the intervention and outcome monitoring 6. Number of hours from charity to deliver the intervention 7. How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  8. Feasibility of intervention

    Time frame: 16 weeks

    • Number of hours from charity to deliver the intervention

  9. Feasibility of intervention

    Time frame: 16 weeks

    • How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  10. Feasibility of intervention

    Time frame: 16 weeks

    • How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

Secondary outcomes

  1. Emotion dysregulation

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    The Difficulties in Emotion Regulation Scale. Higher scores indicate more severe emotion dysregulation difficulties.

  2. Use of DBT coping skills

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    The DBT Ways of Coping Checklist

  3. Anxiety

    Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.

    Generalised Anxiety Disorder Assessment. Higher scores indicate higher levels of anxiety.

  4. Depression

    Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.

    Patient Health Questionnaire. Higher scores indicate higher levels of depression.

  5. Internalised transphobia

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    Gender Minority Stress and Resilience Measure. Higher scores indicate higher internalised transphobia.

  6. Gender-related negative future expectations

    Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.

    Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-related negative future expectations.

  7. Gender-related community connectedness

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-related community connectedness.

  8. Gender-specific pride

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-specific pride

  9. Suicidal behaviours

    Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

    Frequencies of self-harm, suicidal behaviours, A&E attendances, and inpatient bed days.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Gendered Intelligence

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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