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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support. The adapted IERITA intervention is tailored to the participant and can thus entail different adaptions for different participants. Adaptions can entail changes in therapist contact, what material to focus on, and how to work with the treatment. The adapted IERITA intervention is offered between week four and 12.
IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.
Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.
Karolinska Institutet
Stockholm, Sweden
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
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.
Time frame: One-, three- and twelve-months post-treatment
Internet Intervention Patient Adherence Scale (iiPAS)
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.
Time frame: Treatment week 3 and post-treatment (week 12)
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
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).
Time frame: Treatment week 3
The Client Satisfaction Questionnaire (CSQ)
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).
Time frame: Post-treatment (week 12)
Therapist time
Clinicians report time spent on treatment.
Time frame: Post-treatment (week 12)
Number of completed sessions and modules
Clinicians report number of completed sessions and modules for adolescents and parents.
Time frame: Post-treatment (week 12)
Rate of treatment adaptions
Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).
Time frame: Post-treatment (week 12)
Degree of partcipation in data collection
The proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment
Time frame: One-month post-treatment
Adapted ICBT Therapist Rating Scale (ICBT-TRS)
Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.
Time frame: Through study completion, an average of 1 year
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
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.
Time frame: Baseline, one-, three- and twelve-months post-treatment
Children's Global Assessment Scale (CGAS)
The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Time frame: Baseline, one-, three- and twelve-months post-treatment
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
Child Health Utility 9D (CHU-9D)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
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The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Work and Social Adjustment Scale -Youth version (WSAS-Y)
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.
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Work and Social Adjustment Scale - Parent version (WSAS-P)
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.
Time frame: Baseline, one-, three- and twelve-months post-treatment