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

Not Applicable

Recruiting

• Conditions: Nonsuicidal Self-Injury; Self-Harm

• Registration Number: NCT06817278
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Self-injury without the intention to die is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued self-injury entails risks and suffering.

In this randomized controlled pilot trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment.

The main objective is to investigate the project's feasibility and test key components. The specific objectives are:

1. Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources).

2. Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission.

3. Evaluate the performance of the algorithm predicting treatment non-remission.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-15
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Internet Intervention Patient Adherence Scale (iiPAS)	Treatment week 3 and post-treatment (week 12)	The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.
The Client Satisfaction Questionnaire (CSQ)	Post-treatment (week 12)	The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-rated (adolescent and parent).
Degree of partcipation in data collection	One-, three- and twelve-months post-treatment	Number of completed assessments at one-, three- and twelve-months post-treatment.
Adapted ICBT Therapist Rating Scale (ICBT-TRS)	Through study completion, an average of 1 year	Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.
Credibility/Expectancy Questionnaire (CEQ) - 1 item version	Treatment week 3	CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
Therapist time	Post-treatment (week 12)	Clinicians report time spent on treatment.
Rate of treatment adaptions	Post-treatment (week 12)	Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).
Number of completed sessions and modules	Post-treatment (week 12)	Clinicians report number of completed sessions and modules for adolescents and parents.
Deliberate Self-harm Inventory - Youth version (DSHI-Y)	One-, three- and twelve-months post-treatment	The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. Clinician-rated.

Secondary Outcome Measures

Name	Time	Method
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)	Baseline, one-, three- and twelve-months post-treatment	The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent).
Deliberate Self-harm Inventory - Youth version (DSHI-Y)	Baseline, one-, three- and twelve-months post-treatment	The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. Clinician-rated.
The Work and Social Adjustment Scale -Youth version (WSAS-Y)	Baseline, one-, three- and twelve-months post-treatment	The WSAS-Y measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Youths rate their own impairment. Self-rated.
Children's Global Assessment Scale (CGAS)	Baseline, one-, three- and twelve-months post-treatment	The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Child Health Utility 9D (CHU-9D)	Baseline, one-, three- and twelve-months post-treatment	The CHU-9D measures health related quality of life. The scale has 9 items with a summary score between 9 and 45, where a higher score indicates greater health-related quality of life. Self-rated (adolescent).
Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version	Baseline, one-, three- and twelve-months post-treatment	The C-SSRS - 6 item version measures the frequency and severity of suicidal ideation and behaviors. Clinician-rated.
Borderline symtom checklist supplement (BSL)	Baseline, one-, three- and twelve-months post-treatment	The BSL supplement measures the frequency of eleven self-destructive behaviors. The total score ranges from 0 to 44 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).
The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)	Baseline, one-, three- and twelve-months post-treatment	The RCADS-25 measures symptoms of depression and anxiety in children and adolescents. This version has 25 items with a total score between 0 and 75, with higher scores indicating greater levels of symptoms. Self-rated (adolescent).
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)	Baseline, one-, three- and twelve-months post-treatment	The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent).
The Work and Social Adjustment Scale - Parent version (WSAS-P)	Baseline, one-, three- and twelve-months post-treatment	The WSAS-P measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Parents rate their youth's impairment. Self-rated.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden