Self-harm BehaviorNHV_CHILDNCT07898059
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
An observational study of Self-harm Behavior and Eating Disorders, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Self-harm Behavior, Eating Disorders, Non-suicidal Self-injury (NSSI)
- What is being tested?
- National Highly Specialized Care (NHV)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 4 May 2026to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Children and adolescents aged 13-17 years who meet the eligibility criteria for and are receiving National Highly Specialized Care (NHV) for severe self-harm or eating disorders at one of the participating clinical units.
- Parents or legal guardians of children and adolescents receiving NHV at the participating clinical units.
- Informed consent to study participation, according to applicable procedures.
Who cannot join
- Acute medical or psychiatric conditions requiring immediate healthcare interventions that temporarily preclude study participation.
- Inability to independently complete study questionnaires, for example due to language-related difficulties.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Stockholm's child and adolescent psychiatry (BUP Stockholm)
Stockholm, 104 62
Sanna Marek, MSc, +46812353170, sanna.marek@regionstockholm.se
- Recruiting
Stockholm Centre for Eating Disorders (SCÄ)
Stockholm, 172 06
Theresa De Bejczy, MSc, +46812337006, theresa.debejczy@regionstockholm.se
About this study
Official title: National Highly Specialized Care (NHV) for Children and Adolescents With Severe Self-Harm and Eating Disorders: Evaluation of Treatment Experiences, Feasibility, and Clinical Outcomes
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.
Read more
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.
Read the detailed description
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.
- Being tested
- National Highly Specialized Care (NHV)
- Keywords
- Dialectical Behavior Therapy, Cognitive Behavior Therapy, National Highly Specialized Care, Severe Self-Harm, Treatment Outcomes, Severe and Enduring Eating Disorders, Treatment Resistant Disorders
- Medical subject headings
- Feeding and Eating Disorders, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National Highly Specialized Care (NHV)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients and Parents/Legal Guardians in National Highly Specialized Care | 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. Receives: Behavioral: National Highly Specialized Care (NHV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 May 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-harm BehaviorStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Wolf-Arehult, Karolinska Institutet
- Investigators
- Martina Wolf-Arehult, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898059
- Sponsor's protocol ID
- NHV_CHILD
- Acronym
- NHV_CHILD
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Highly Specialized Care (NHV) for Children and Adolescents With Severe Self-Harm and Eating Disorders: Evaluation of Treatment Experiences, Feasibility, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07898059
- Acronym / sponsor ID
- NHV_CHILD / NHV_CHILD
- Keywords
- Dialectical Behavior Therapy, Cognitive Behavior Therapy, National Highly Specialized Care, Severe Self-Harm, Treatment Outcomes, Severe and Enduring Eating Disorders, Treatment Resistant Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and Parents/Legal Guardians in National Highly Specialized Care | – | Behavioral: National Highly Specialized Care (NHV)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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Children and adolescents aged 13-17 years who meet the eligibility criteria for and are receiving National Highly Specialized Care (NHV) for severe self-harm or eating disorders at one of the participating clinical units.
- Parents or legal guardians of children and adolescents receiving NHV at the participating clinical units.
- Informed consent to study participation, according to applicable procedures.
Key exclusion criteria (2 listed)
- Acute medical or psychiatric conditions requiring immediate healthcare interventions that temporarily preclude study participation.
- Inability to independently complete study questionnaires, for example due to language-related difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Patients and Parents/Legal Guardians in National Highly Specialized Care |
Primary outcome
Patients' and Parents' or Legal Guardians' Experiences of National Highly Specialized Care
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.
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.
Treatment Completion Rate
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.
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.
Treatment Attendance
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 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.
19 secondary outcomes
Treatment Credibility and Expectancy (Credibility/Expectancy Questionnaire; CEQ)
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)
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
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)
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)
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)
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
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
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
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
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)
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)
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)
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)
Time frame: NHV-SCÄ: At baseline (first treatment week), and at 12-month follow-up after treatment completion.
Change in Perceived Emotional Invalidation (PIES)
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)
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)
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martina Wolf-Arehult, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-harm Behavior and Eating Disorders, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanna Marek, MSc (+46812353170, sanna.marek@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' and Parents' or Legal Guardians' Experiences of National Highly Specialized Care (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.