Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm (NCT06297824) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm
Sweden21 participantsStarted 2023-10-10
Plain-language summary
Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.
A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.
Who can participate
Age range
13 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 13-17 years of age;
. having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year;
. having engaged in ≥1 DSH episode during the past month;
. having ongoing psychiatric treatment in the community;
. having at least one caregiver or other significant adult, committed to participate in the parent program; and
. stability of psychotropic medications
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility measure, recruitment rate
Timeframe: through study completion, an average of 1 year
2
Feasibility measures, proportion included
Timeframe: through study completion, an average of 1 year
3
Feasibility measures, compliance
Timeframe: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
4
Feasibility measures, attrition
Timeframe: Pre-treatment to post-treatment EOT (12 weeks)
5
Feasibility measures, client satisfaction
Timeframe: at post-treatment EOT (12 weeks)
6
Feasibility measures, negative effects of treatment