Trial · NCT07898059
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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. |
| Secondary | Change in Emotional and Behavioral Difficulties (SDQ) - Patient and Parent Reports | 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. | 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. |
| Secondary | Change in Functional Impairment (WSAS) - Patient and Parent Reports | 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). | 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. |
| Secondary | Change in Observed Eating Disorder Behaviors (ABOS) - Parent Reports | 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. | 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. |
| Secondary | Change in Suicidal Ideation (SIQ-15) | 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. | 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. |
| Secondary | Change in Substance Use and Substance-Related Problems (ASSIST-Y) | NHV-BUP: At baseline (first treatment week) and at 6-month follow-up after treatment completion for patients with self-harm only. | 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. |
| Secondary | Change in Autistic Traits (AQ-10) | 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. | 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. |
| Secondary | Change in ADHD Symptoms (ASRS) | NHV-SCÄ: At baseline (first treatment week), and at 12-month follow-up after treatment completion. | 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. |
| Secondary | Change in Perceived Emotional Invalidation (PIES) | 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. | 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. |
| Secondary | Change in Psychological Well-Being (WHO-5) | 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. | 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. |
| Secondary | Change in Weekly Self-Harm Behaviors (DSHI-9-7days) | 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. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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