Trial · NCT07898059
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
NCT07898059, Recruiting, Karolinska Institutet
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders. Trials, record NCT07898059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898059
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
- NCT number
- NCT07898059
- Status
- Recruiting
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Karolinska Institutet
- Conditions
- Self-harm Behavior, Eating Disorders, Non-suicidal Self-injury (NSSI)
- Interventions
- National Highly Specialized Care (NHV)
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients' and Parents' or Legal Guardians' Experiences of National Highly Specialized Care | 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. |
| Primary | Treatment Completion Rate | 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. |
| Primary | Treatment Attendance | 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. |
| Secondary | Treatment Credibility and Expectancy (Credibility/Expectancy Questionnaire; CEQ) | During the initial phase of NHV treatment (weeks 1-4). Only parents/legal guardians. | 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. |
| Secondary | Treatment Satisfaction (Treatment Satisfaction Scale, Version 2; TSS-2) | At regular NHV treatment completion, i.e. after 12-13 weeks. Only parents/legal guardians. | 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. |
| Secondary | Change in Self-Harm Behaviors (DSHI-9 and Two Additional Items), 1 month | 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. | 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). |
| Secondary | Change in Emotion Regulation Difficulties (DERS-16) | 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. | 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. |
| Secondary | Change in Eating Disorder Psychopathology (EDE-Q) | 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. | 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. |
| Secondary | Change in Eating Disorder-Related Psychosocial Impairment (CIA) | 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. | 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. |
| Secondary | Change in Anxiety and Depression Symptoms (RCADS) - Patient and Parent Reports | 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. | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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