Prima Barn och Vuxenpsykiatri Handen och Järva
Stockholm, Spånga, 16374, Sweden
NCT Number: NCT06297824
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.
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Notify Me13 year–17 year
All sexes
Interventional
Not applicable
Stockholm, Spånga, 16374, Sweden
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. Adaptations to ERGT will result in a 12 session long treatment for adolescents Emotion regulation group therapy for Adolescents (ERGT-A). A parallel parent group focused on strengthening parental skills will be given alongside ERGT-A (5 sessions)
Method: A quantitative feasibility open trial (N=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.
Feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance.
Preliminary effects measures include DSH, emotion regulation ability, anxiety and depression.
Method: A qualitative interview study. Using thematic analysis to explore participants' experience of ERGT-A and parent group
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Emotion regulation group therapy for adolescents
Time frame: through study completion, an average of 1 year
Recruitment rate
Time frame: through study completion, an average of 1 year
Proportion of participants invited to participate who accepts and is included (higher = better, min 0%- max 100%)
Time frame: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
Compliance, no of sessions attended (>50%), (higher = better, min 0-max 10)
Time frame: Pre-treatment to post-treatment EOT (12 weeks)
Attrition, percent of included participants who drops out of treatment (lower = better, min 0%- max 100%)
Time frame: at post-treatment EOT (12 weeks)
Mean score on Client satisfaction questionnaire> 25 (higher= better, min 8-max 32)
Time frame: at post-treatment EOT (12 weeks)
Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)
Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)
Mean Deliberate self-harm frequency at post-treatment (min 0-max 100, lower=better)
Time frame: Post-treatment (EOT) to follow-up (4 weeks)
Mean Deliberate self-harm frequency at post-treatment and 1MFU lower than at post-treatment (min 0-max 100, lower=better)
Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)
Mean difficulty in emotion regulation rating (DERS-16) at post-treatment lower than at pre-treatment (min 16, max 80, lower=better)
Time frame: Post-treatment (EOT) to follow-up (4 weeks)
Mean difficulty in emotion regulation rating (DERS-16) at 1MFU lower than at post-treatment (min 16, max 80, lower=better)
Karolinska Institutet
Other
Can a Brief Emotion Regulation Group Therapy Help Adolescents With Deliberate Self-Harm? A Feasibility Study and a Qualitative Interview Study
Acronym: ERGT-A
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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