A Phase 1 interventional study of Dialectical behavioural therapy (DBT)-informed skills group in Emotional Regulation, sponsored by King's College London. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by King's College London · Phase 1, Interventional, and Treatment
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
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.
King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
Attend DBT-informed skills group intervention
Behavioral: Dialectical behavioural therapy (DBT)-informed skills group
16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators
Acceptability of intervention
1. Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.
Time frame: 16 weeks
Acceptability of intervention
2. Client Satisfaction Questionnaire will be completed post-intervention.
Time frame: 16 weeks
Feasibility of intervention
1. Eligibility rates at screening
Time frame: 16 weeks
Feasibility of intervention
2. 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.
Time frame: 16 weeks
Feasibility of intervention
3. 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)
Time frame: 16 weeks
Feasibility of intervention
4. Cost and time to train a charity support worker
Time frame: 16 weeks
Feasibility of intervention
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)
Time frame: 16 weeks
Feasibility of intervention
6. Number of hours from charity to deliver the intervention
Time frame: 16 weeks
Feasibility of 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)
Time frame: 16 weeks
Feasibility of intervention
8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)
Time frame: 16 weeks
Emotion dysregulation
The Difficulties in Emotion Regulation Scale. Higher scores indicate more severe emotion dysregulation difficulties.
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Use of DBT coping skills
The DBT Ways of Coping Checklist
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Anxiety
Generalised Anxiety Disorder Assessment. Higher scores indicate higher levels of anxiety.
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Depression
Patient Health Questionnaire. Higher scores indicate higher levels of depression.
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Internalised transphobia
Gender Minority Stress and Resilience Measure. Higher scores indicate higher internalised transphobia.
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Gender-related negative future expectations
Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-related negative future expectations.
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Gender-related community connectedness
Gender Minority Stress and Resilience Measure. Higher scores indicate higher 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-specific pride
Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-specific pride
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Suicidal behaviours
Frequencies of self-harm, suicidal behaviours, A\&E attendances, and inpatient bed days.
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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King's College London