An observational study in Self-harm Behavior, Eating Disorders and Non-suicidal Self-injury (NSSI), sponsored by Karolinska Institutet. Recruiting at 2 sites in Sweden. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Karolinska Institutet · Observational
National Highly Specialized Care (NHV) is provided in Sweden to children and adolescents with severe and treatment-resistant self-harm or eating disorders when previous treatment has not led to sufficient improvement. NHV offers intensive, individualized care delivered by multidisciplinary teams with specialized expertise.
This observational study aims to evaluate NHV provided at two specialized psychiatric services in Region Stockholm: Child and Adolescent Psychiatry Stockholm (BUP Stockholm), for severe self-harm, and the Stockholm Centre for Eating Disorders (SCÄ), for children with severe eating disorders.
The primary aim is to explore patients' and their parents' or legal guardians' experiences of NHV and their perceptions of its effects through qualitative interviews conducted at treatment completion and one year later.
Secondary aims are to evaluate treatment feasibility, adherence, and changes in psychiatric symptoms, functioning, and skills during and after treatment. Data are collected through questionnaires completed by patients and their parents or legal guardians, clinical assessments, and medical records.
Assessments are conducted 1) at baseline, which is defined as the first treatment week, 2) after six weeks of treatment, 3) at regular treatment completion (approximately 12-13 weeks), 4) if the treatment is extended by 4-6 weeks due to, for example, severe comorbidity, an additional assessment is conducted at the end of this treatment extension, 5) at six-month follow-up, and 6) at twelve-month follow-up after treatment completion.
The study aims to improve understanding of the benefits and limitations of NHV and contribute to the further development of specialized psychiatric care for children and adolescents with complex treatment needs.
National Highly Specialized Care (NHV) represents a specialized level of psychiatric care in Sweden for patients with severe and treatment-resistant conditions requiring highly specialized expertise and resources. NHV is intended for patients who have not achieved sufficient improvement despite appropriate treatment at the regional level. An important objective is to address barriers to successful treatment and facilitate continued care at a less intensive level.
This prospective observational study evaluates NHV for children and adolescents with severe self-harm or eating disorders at two specialized services in Region Stockholm: Child and Adolescent Psychiatry Stockholm (BUP Stockholm) and the Stockholm Centre for Eating Disorders (SCÄ).
NHV typically includes approximately 12-13 weeks of intensive inpatient and psychotherapeutic treatment, with individualized treatment plans developed by multidisciplinary teams. Treatment approaches are selected according to clinical needs and treatment history, and may include dialectical behavior therapy (DBT) for self-harm, or family-based treatment (FBT), or cognitive behavioral therapy (CBT) for eating disorders. Treatment is provided as part of routine clinical care and is not assigned by the research protocol.
The primary objective is to investigate patients' and their parents' or legal guardians' experiences of NHV and their perceptions of treatment effects. Semi-structured qualitative interviews are conducted at treatment completion and approximately 12 months in connection with follow-up assessments. Interviews are analyzed using thematic analysis to identify experiences, perceived benefits, challenges, and opportunities for improvement.
Secondary objectives include evaluating treatment feasibility and adherence, including the proportion of patients accepting treatment, the proportion of patients completing treatment according to the treatment plan, and attendance at planned treatment sessions, as well as parents' or legal guardians' ratings of treatment credibility and expectancy at baseline and treatment satisfaction at treatment completion. Changes in psychiatric symptoms, self-harm, eating disorder symptoms, weight where relevant, psychological functioning, and skills are also examined.
Quantitative data are collected through patient- and parent/legal guardian-reported questionnaires, clinical assessments, and medical records.
Assessments are conducted 1) at baseline, which is defined as the first treatment week, 2) after six weeks of treatment, 3) at regular treatment completion (approximately 12-13 weeks), 4) if the treatment is extended by 4-6 weeks due to, for example, severe comorbidity, an additional assessment is conducted at the end of this treatment extension, 5) at six-month follow-up, and 6) at twelve-month follow-up after treatment completion.
The study aims to improve understanding of the benefits and limitations of NHV and contribute to the further development of specialized psychiatric care for children and adolescents with complex treatment needs.
Medical record data are also used to examine healthcare utilization, including days of inpatient care, number of emergency visits and involuntary care, medication use, and weight-related outcomes where applicable. These variables are examined during the 12 months before NHV and compared with the 12 months following treatment completion.
The study combines qualitative and quantitative methods to provide a comprehensive evaluation of the experiences, feasibility, and clinical outcomes of NHV. Findings are intended to support the development and improvement of highly specialized psychiatric care for children and adolescents with complex and severe psychiatric conditions.
754 studies on the registry are indexed under Feeding and Eating Disorders; 161 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 185 observational studies indexed under Feeding and Eating Disorders.
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The study population consists of children and adolescents aged 13-17 years who meet the eligibility criteria for National Highly Specialized Care (NHV) for severe self-harm or eating disorders, and their parents or legal guardians. Participants will be recruited from two specialized psychiatric clinical units within Region Stockholm, Sweden: NHV-BUP (severe self-harm) and NHV-SCÄ (eating disorders). Eligible patients and their parents or legal guardians will be invited to participate in the study in connection with NHV treatment.
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Exclusion Criteria:
This cohort includes approximately 60 children and adolescents aged 13-17 years receiving National Highly Specialized Care (NHV) for severe and treatment-resistant self-harm or eating disorders, as well as at least 60 parents or legal guardians. Patients receive individualized specialized treatment based on their clinical needs and treatment history. Patients and parents or legal guardians participate in assessments of treatment experiences, feasibility, and clinical outcomes during treatment and at follow-up.
Behavioral: National Highly Specialized Care (NHV)
National Highly Specialized Care (NHV) provides individualized treatment for children and adolescents with severe and treatment-resistant self-harm or eating disorders. Treatment typically involves 12-13 weeks of intensive inpatient and psychotherapeutic care delivered by multidisciplinary teams. Treatment approaches are selected based on clinical needs and treatment history and may include dialectical behavior therapy (DBT) or its adaptations, family-based treatment (FBT), cognitive behavioral therapy (CBT), or other evidence-based approaches. Multidisciplinary teams also provide interventions involving social workers, physiotherapists, occupational therapists, and other professionals according to individual needs. Treatment includes preparation and follow-up phases and is determined independently of study participation.
Patients' and Parents' or Legal Guardians' Experiences of National Highly Specialized Care
Qualitative semi-structured interviews exploring patients' and their parents' or legal guardians' experiences of NHV, including perceived treatment benefits, negative effects, challenges, and areas for improvement. Interview data will be analyzed using reflexive thematic analysis.
Time frame: 1) At treatment completion, i.e., after 12-13 weeks if standard treatment is provided, or after 16-20 weeks if more extensive treatment is required, and 2) 12 months after treatment completion.
Treatment Completion Rate
Proportion of patients who complete the planned National Highly Specialized Care (NHV) treatment program, based on information from the treating clinician. Higher percentages indicate higher treatment completion rates.
Time frame: From treatment initiation to treatment completion, i.e. 12-13 weeks if standard treatment is provided, or 16-20 weeks if more extensive treatment is required.
Treatment Attendance
Treatment attendance will be evaluated in relation to the individual's planned treatment activities (individual therapy sessions), based on information provided by the treating clinician. Higher attendance indicates greater participation.
Time frame: Throughout the NHV treatment period, i.e. 12-13 weeks if standard treatment is provided, or 16-20 weeks if more extensive treatment is required
Treatment Credibility and Expectancy (Credibility/Expectancy Questionnaire; CEQ)
Treatment credibility and expectancy are assessed using the six-item Credibility/Expectancy Questionnaire (CEQ). The instrument comprises two subscales: Credibility (3 items) and Expectancy (3 items). Four items are rated on a 0-8 scale, and two items on a 0-100% scale. Percentage ratings are converted to a 0-8 scale before calculating the Expectancy score. Each subscale ranges from 0 to 24, with higher scores indicating greater treatment credibility or higher expectations of treatment outcomes. The two subscales are analyzed separately.
Time frame: During the initial phase of NHV treatment (weeks 1-4). Only parents/legal guardians.
Treatment Satisfaction (Treatment Satisfaction Scale, Version 2; TSS-2)
Treatment satisfaction is assessed using the Treatment Satisfaction Scale (TSS). Items 1-5 are rated on a four-point scale (0-3) and summed to a total score ranging from 0 to 15, with higher scores indicating greater treatment satisfaction. The final item is analyzed separately as an overall assessment of the treatment unit.
Time frame: At regular NHV treatment completion, i.e. after 12-13 weeks. Only parents/legal guardians.
Change in Self-Harm Behaviors (DSHI-9 and Two Additional Items), 1 month
Self-harm behaviors will be assessed using a modified 9-item version of the Deliberate Self-Harm Inventory (DSHI-9), in which the first two items of the original instrument have been combined into one. The instrument assesses the frequency of different self-harm behaviors during the past month. Each item is scored from 0 (no occurrences) to 6 (more than five occurrences). If a behavior has occurred more than five times, patients are also asked to report the total number of occurrences. The total score ranges from 0 to 54, with higher scores indicating more frequent self-harm. Two additional items assess deliberate foreign body ingestion (DFBI) and deliberate self-harm through medication overdose or ingestion of toxic substances. These items will be analyzed separately and are not included in the DSHI-9 total score. Changes in self-harm behaviors will be evaluated across assessment points (self-report for patients with self-harm).
Time frame: 1) at baseline (first treatment week), 2) after 6 weeks, 3) at regular treatment completion (12-13 weeks), 4) at the end of treatment extension (if extended by 4-6 weeks), 5) at 6-month follow-up after completion, and 6) at 12-month follow-up.
Change in Emotion Regulation Difficulties (DERS-16)
Difficulties in emotion regulation will be assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16) by patients and parents or legal guardians. Each item is scored from 1 to 5, yielding a total score ranging from 16 to 80. Higher scores indicate greater difficulties in emotion regulation. Changes in total scores will be evaluated across assessment points.
Time frame: 1) at baseline (first treatment week), 2) after 6 weeks, 3) at regular treatment completion (12-13 weeks), 4) at the end of treatment extension (if extended by 4-6 weeks), 5) at 6-month follow-up after completion, and 6) at 12-month follow-up.
Change in Eating Disorder Psychopathology (EDE-Q)
Eating disorder psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q) (self-report by ED patients). The questionnaire assesses eating disorder symptoms and attitudes related to eating, weight, and shape over the preceding 28 days. The Global Score is calculated as the mean of the relevant item scores and ranges from 0 to 6, with higher scores indicating greater eating disorder psychopathology. Changes in the Global Score will be evaluated across assessment points.
Time frame: 1) at baseline (first treatment week), 2) after 6 weeks, 3) at regular treatment completion (12-13 weeks), 4) at the end of treatment extension (if extended by 4-6 weeks), 5) at 6-month follow-up after completion, and 6) at 12-month follow-up.
Change in Eating Disorder-Related Psychosocial Impairment (CIA)
Eating disorder-related psychosocial impairment will be assessed using the 16-item Clinical Impairment Assessment (CIA) (self-rate by ED-patients). The questionnaire assesses the impact of eating disorder symptoms on personal, cognitive, and social functioning during the preceding 28 days. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 48. Higher scores indicate greater psychosocial impairment. Changes in total scores will be evaluated across assessment points.
Time frame: 1) at baseline (first treatment week), 2) after 6 weeks, 3) at regular treatment completion (12-13 weeks), 4) at the end of treatment extension (if extended by 4-6 weeks), 5) at 6-month follow-up after completion, and 6) at 12-month follow-up.
Change in Anxiety and Depression Symptoms (RCADS) - Patient and Parent Reports
Anxiety and depressive symptoms will be assessed using the Revised Child Anxiety and Depression Scale (RCADS), completed separately by patients and their parents or legal guardians. The questionnaire assesses symptoms of separation anxiety, social phobia, generalized anxiety, panic disorder, obsessive-compulsive disorder, and major depression. Patient- and parent-reported scores will be analyzed separately. Changes in scores will be evaluated across assessment points. The 47-item RCADS assesses symptoms of anxiety and depression. Each item is rated on a four-point scale (0-3), yielding a total score ranging from 0 to 141. Higher scores indicate more severe anxiety and depressive symptoms.
Time frame: At baseline (first treatment week) and regular treatment completion (12-13 weeks) for patients and parents or legal guardians at both sites, and at 6- and 12-month follow-up. At the end of treatment extension (if extended by 4-6 weeks) at NHV-BUP.
Change in Emotional and Behavioral Difficulties (SDQ) - Patient and Parent Reports
Emotional and behavioral difficulties will be assessed using the Strengths and Difficulties Questionnaire (SDQ), completed by patients at NHV-BUP and by parents or legal guardians at both NHV-BUP and NHV-SCÄ. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties. Patient- and parent-reported scores will be analyzed separately. Changes in scores will be evaluated across assessment points.
Time frame: At baseline (first treatment week), at regular treatment completion (12-13 weeks), and at 6- and 12-month follow-up for patients with self-harm as well as parents at both sites.
Change in Functional Impairment (WSAS) - Patient and Parent Reports
Functional impairment will be assessed using the Work and Social Adjustment Scale (WSAS), completed separately by patients and their parents or legal guardians at NHV-BUP. The questionnaire consists of five items assessing impairment in everyday functioning. Each item is scored from 0 to 8, yielding a total score ranging from 0 to 40. Higher scores indicate greater functional impairment. Patient- and parent-reported scores will be analyzed separately. Changes in total scores will be evaluated across assessment points.
Time frame: NHV-BUP: At baseline (first treatment week) and at 6- and 12-month follow-up after treatment completion for patients with self-harm and their parents. For these parents, also at treatment completion (12-13 weeks).
Change in Observed Eating Disorder Behaviors (ABOS) - Parent Reports
Eating disorder-related behaviors will be assessed using the 30-item Anorectic Behavior Observation Scale (ABOS), completed by parents or legal guardians of patients receiving NHV treatment at NHV-SCÄ. The questionnaire assesses observable eating disorder-related behaviors during the preceding month. Each item is scored as 0 (No), 1 (Uncertain), or 2 (Yes), yielding a total score ranging from 0 to 60. Higher scores indicate more pronounced eating disorder-related behaviors. Changes in total scores will be evaluated across assessment points.
Time frame: NHV-SCÄ: At baseline, at regular treatment completion (approximately 12-13 weeks), and at 6- and 12-month follow-up after treatment completion. Completed by parents or legal guardians only.
Change in Suicidal Ideation (SIQ-15)
Suicidal ideation will be assessed using the 15-item Suicidal Ideation Questionnaire (SIQ-15), completed by patients receiving NHV treatment at NHV-BUP. The instrument assesses the frequency of suicidal thoughts during the preceding month. Each item is scored from 0 (never) to 6 (almost every day), yielding a total score ranging from 0 to 90. Higher scores indicate more frequent suicidal ideation. Changes in total scores will be evaluated across assessment points.
Time frame: NHV-BUP: At baseline (first treatment week), at 6 weeks, at regular treatment completion (approximately 12-13 weeks), and at 6- and 12-month follow-up after treatment completion for patients with self-harm.
Change in Substance Use and Substance-Related Problems (ASSIST-Y)
Substance use and substance-related problems will be assessed using the Alcohol, Smoking and Substance Involvement Screening Test for Youth (ASSIST-Y), based on WHO ASSIST version 3.1 and adapted for adolescents. The instrument assesses lifetime substance use, substance use during the preceding three months, and associated problems across different substance categories. Substance-specific involvement scores are calculated by summing items 2-6, except for tobacco, for which item 5 is excluded. Scores range from 0 to 33 for tobacco and 0 to 33 for other substances, with higher scores indicating greater substance involvement and related problems. Substance categories will be analyzed separately. Changes in scores will be evaluated across assessment points.
Time frame: NHV-BUP: At baseline (first treatment week) and at 6-month follow-up after treatment completion for patients with self-harm only.
Change in Autistic Traits (AQ-10)
Autistic traits will be assessed using the 10-item Autism Spectrum Quotient (AQ-10), completed by patients receiving NHV treatment at NHV-SCÄ. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 10. Higher scores indicate more autistic traits. Changes in total scores will be evaluated across assessment points.
Time frame: NHV-SCÄ: At baseline (first treatment week), at regular treatment completion (approximately 12-13 weeks), and at 12-month follow-up after treatment completion. Completed by patients with eating disorders only.
Change in ADHD Symptoms (ASRS)
ADHD symptoms will be assessed using the 18-item adolescent version of the Adult ADHD Self-Report Scale (ASRS), completed by patients receiving NHV treatment at NHV-SCÄ. The questionnaire assesses symptoms of inattention and hyperactivity/impulsivity during the preceding six months. Each item has five response options, ranging from never to very often. When scored from 0 to 4 per item, the total score ranges from 0 to 72, with higher scores indicating more frequent ADHD symptoms. Scores will be analyzed descriptively across assessment points. Completed by patients only.
Time frame: NHV-SCÄ: At baseline (first treatment week), and at 12-month follow-up after treatment completion.
Change in Perceived Emotional Invalidation (PIES)
Perceived emotional invalidation will be assessed using the 10-item Perceived Invalidation of Emotion Scale (PIES), completed by patients. The instrument assesses the frequency of perceived emotional invalidation in interpersonal relationships during the preceding month. Each item is scored from 1 (almost never) to 5 (almost always), yielding a total score ranging from 10 to 50. Higher scores indicate greater perceived emotional invalidation. An additional question identifies the relationships considered when completing the questionnaire and is not included in the total score. Changes in total scores will be evaluated across assessment points.
Time frame: NHV-BUP: At baseline (first treatment week), at 6 weeks, and at 12-month follow-up after treatment completion. NHV-SCÄ: At baseline and at regular treatment completion (see above), at 6- and 12-month follow-up after treatment completion. Only patients.
Change in Psychological Well-Being (WHO-5)
Psychological well-being will be assessed using the 5-item World Health Organization-Five Well-Being Index (WHO-5). Each item is scored from 0 (at no time) to 5 (all of the time), yielding a raw total score ranging from 0 to 25. Higher scores indicate greater psychological well-being. The questionnaire assesses well-being during the preceding two weeks. Changes in scores will be evaluated across assessment points. Each assessment covers the preceding two weeks.
Time frame: NHV-BUP: At baseline (first treatment week), at regular treatment completion (approximately 12-13 weeks), and at 6-month follow-up after treatment completion. Only patients.
Change in Weekly Self-Harm Behaviors (DSHI-9-7days)
Self-harm behaviors will be assessed using a modified 9-item version of the Deliberate Self-Harm Inventory (DSHI-9), in which the first two items of the original instrument have been combined into one. The instrument assesses the frequency of different self-harm behaviors during the preceding week. Each item is scored from 0 (no occurrences) to 6 (more than five occurrences). If a behavior has occurred more than five times, patients are also asked to report the total number of occurrences. The total score ranges from 0 to 54, with higher scores indicating more frequent self-harm. Two additional items assess deliberate foreign body ingestion (DFBI) and deliberate self-harm through medication overdose or ingestion of toxic substances. These items are analyzed separately and are not included in the DSHI-9 total score. Changes in self-harm behaviors will be evaluated across assessment points.
Time frame: Weekly during NHV treatment (self-harm group), i.e., during 12-13 weeks if standard treatment is provided, or during 16-20 weeks if more extensive treatment is required. Only patients.
Change in Weekly Eating Disorder Symptoms (EDSL)
Eating disorder symptoms will be assessed using the 8-item Eating Disorder Symptom List (EDSL), completed by patients receiving NHV treatment at NHV-SCÄ. The instrument assesses the number of days during the preceding week on which patients experienced dietary restriction, binge eating, compensatory behaviors, fear of weight gain, and weight- or shape-related concerns. Each item is scored from 0 to 7 days. If all items are summed, the total score ranges from 0 to 56, with higher scores indicating more frequent eating disorder symptoms. Changes in symptom frequency will be evaluated throughout treatment.
Time frame: Weekly during NHV treatment (eating disorder group), i.e., during 12-13 weeks if standard treatment is provided, or during 16-20 weeks if more extensive treatment is required. Only patients.
Change in Parental Self-Efficacy Regarding Suicidality (PSESS)
Parental self-efficacy regarding their child's suicidality will be assessed using the 12-item Parent Self-Efficacy for Suicide Scale (PSESS), completed by parents or legal guardians of patients receiving NHV treatment for severe self-harm at NHV-BUP. The instrument assesses parents' perceived confidence in recognizing warning signs, discussing suicidal thoughts, responding to suicidal crises, supporting safety planning, and helping their child access appropriate support. Each item is rated from 0 (not at all confident) to 10 (completely confident). If all items are summed, the total score ranges from 0 to 120, with higher scores indicating greater perceived parental self-efficacy. Changes in scores will be evaluated across assessment points.
Time frame: NHV-BUP: At baseline (first treatment week), at treatment completion (approximately 12-13 weeks), and at 6- and 12-month follow-up after treatment completion. Parents only.
Plan to share: Undecided — The possibility of combining de-identified individual participant data across National Highly Specialized Care (NHV) units in Sweden is currently under discussion. No formal decision has been made, and the necessary ethical approvals have not yet been obtained. Any future data sharing would be subject to appropriate ethical and legal approvals and applicable data protection requirements.
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Started May 2026 (actual). Primary completion is estimated for May 2030, 48 months after the start.
Of 67 non-industry observational studies under Feeding and Eating Disorders, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 87. This study's planned 48 months is above that.
Counting every sponsor, half of 70 studies reached it within 42 months; a quarter within 16 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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