Active — Not RecruitingNot Applicable

Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

Sweden100 participantsStarted 2025-01-15

Plain-language summary

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

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 old * At least one self-injury episode in the past three months * A parent willing to engage in the parent program Exclusion Criteria: * Immediate suicide risk * Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS) * Social problems needing immediate intervention (e.g., violence within the family) * Ongoing dialectical behavior therapy for adolescents

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

Deliberate Self-harm Inventory - Youth version (DSHI-Y)

Timeframe: One-, three- and twelve-months post-treatment

Internet Intervention Patient Adherence Scale (iiPAS)

Timeframe: Treatment week 3 and post-treatment (week 12)

Credibility/Expectancy Questionnaire (CEQ) - 1 item version

Timeframe: Treatment week 3

The Client Satisfaction Questionnaire (CSQ)

Timeframe: Post-treatment (week 12)

Therapist time

Timeframe: Post-treatment (week 12)

Number of completed sessions and modules

Timeframe: Post-treatment (week 12)

Rate of treatment adaptions

Timeframe: Post-treatment (week 12)

Trial details

NCT IDNCT06817278

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Nonsuicidal Self-Injury trials

Plain-language summary

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.

What they're measuring

Deliberate Self-harm Inventory - Youth version (DSHI-Y)

Timeframe: One-, three- and twelve-months post-treatment

Internet Intervention Patient Adherence Scale (iiPAS)

Timeframe: Treatment week 3 and post-treatment (week 12)

Credibility/Expectancy Questionnaire (CEQ) - 1 item version

Timeframe: Treatment week 3

The Client Satisfaction Questionnaire (CSQ)

Timeframe: Post-treatment (week 12)

Therapist time

Timeframe: Post-treatment (week 12)

Number of completed sessions and modules

Timeframe: Post-treatment (week 12)

Rate of treatment adaptions

Timeframe: Post-treatment (week 12)