Trial · NCT07893145
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment completion | From the start of SSCM-Youth to treatment completion, approximately week 25 for the standard treatment, or week 40 for severe conditions (earlier termination is possible if the patient reports no remaining eating disorder symptoms). | Proportion of participants who complete the SSCM-Youth treatment as planned. Treatment completion will be used as a primary indicator of the feasibility of delivering SSCM-Youth to children and adolescents with anorexia nervosa or atypical anorexia nervosa. |
| Primary | Treatment adherence | From the start of SSCM-Youth to treatment completion, approximately week 25 for the standard treatment, or week 40 for severe conditions (earlier termination is possible if the patient reports no remaining eating disorder symptoms). | Number and proportion of planned SSCM-Youth treatment sessions attended by participants. |
| Primary | Patients' and Parents' or Legal Guardians' Experiences of SSCM | At treatment completion, after approximately 25 weeks for standard treatment or 40 weeks for patients with severe conditions and comorbidity. Treatment may end earlier if the patient reports no remaining eating disorder symptoms. | Qualitative semi-structured interviews exploring patients' and their parents' or legal guardians' experiences of SSCM, including helpful aspects, potential challenges, and possibilities for improvement. Interview data will be analyzed using reflexive thematic analysis. |
| Secondary | Change in body mass index (BMI) | Assessments: 1) at treatment week 1 (baseline), 2) at week 13 for standard treatment, or week 20 for severe conditions, 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | Body mass index (BMI; kg/m²) will be assessed to evaluate preliminary changes in weight status during treatment and follow-up. |
| Secondary | Change in eating disorder psychopathology | Assessments: 1) at treatment week 1 (baseline), 2) at week 13 for standard treatment, or week 20 for severe conditions, 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | Eating disorder psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q). The global score ranges from 0 to 6, with higher scores indicating greater eating disorder psychopathology. |
| Secondary | Change in Eating Disorder-Related Psychosocial Impairment (CIA) | Assessments: 1) at treatment week 1 (baseline), 2) at week 13 for standard treatment, or week 20 for severe conditions, 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | Eating disorder-related psychosocial impairment is assessed using the Clinical Impairment Assessment (CIA), a 16-item self-report questionnaire. Total scores range from 0 to 48, with higher scores indicating greater impairment. |
| Secondary | Change in Anxiety and Depressive Symptoms (RCADS) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | 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 Difficulties in Emotion Regulation (DERS-16) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. Only patients. | Emotion regulation difficulties are assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16). Total scores range from 16 to 80, with higher scores indicating greater difficulties in emotion regulation. |
| Secondary | Change in Social Safeness and Pleasure (SSPS) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. Only patients. | Feelings of social safeness, connectedness, and pleasure in social relationships are assessed using the 11-item Social Safeness and Pleasure Scale (SSPS). Total scores range from 0 to 44, with higher scores indicating greater perceived social safeness and pleasure. |
| Secondary | Change in Deliberate Self-Harm (DSHI-9) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. 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 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). |
| Secondary | Change in Perceived Emotional Invalidation (PIES) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months 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 Parent-Reported Anorectic Behaviors (ABOS) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | 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 Parent-Reported Emotional and Behavioral Difficulties (SDQ) | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. Only parents. | Emotional and behavioral difficulties are assessed using the parent-report version of the Strengths and Difficulties Questionnaire (SDQ). The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater difficulties. |
| Other | Parent-Reported Treatment Credibility and Expectancy (CEQ) | Assessments: 1) at baseline, i.e. treatment week 1. Only parents. | Parents' or caregivers' perceptions of treatment credibility and expectations regarding treatment outcomes are assessed using the 6-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. |
| Other | Parent-Reported Treatment Satisfaction (TSS-2) | Assessments: 3) at treatment completion, approximately week 25 for the standard program, or week 40 for the program for severe, and 4) 3 months after treatment completion. Only parents. | Parents' or caregivers' satisfaction with SSCM-Youth is assessed using the 6-item Treatment Satisfaction Scale-2 (TSS-2). 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. |
| Other | Brief, repeated assessment of eating disorder symptoms | From treatment initiation to treatment completion, every fifth week during ongoing treatment (i.e., weeks 5, 10, 15, 20, 25, 30, and 35, as applicable), excluding baseline and treatment completion assessments. | Eating disorder symptoms will be assessed using the brief 8-item Eating Disorder Symptom List (EDSL), completed by patients every fifth week during treatment. 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. |
| Other | CGAS - Children's Global Assessment Scale | Assessments: 1) at treatment week 1 (baseline), 3) at treatment completion, approximately week 25 for standard, or week 40 for severe, and 4) 3 months after treatment completion. | The Children's Global Assessment Scale (CGAS) is a clinician-rated measure of overall psychosocial functioning in children and adolescents. Scores range from 1 to 100, with higher scores indicating better functioning. |
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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