An interventional study of Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth) in Anorexia Nervosa and Atypical Anorexia Nervosa, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
This study evaluates an adaptation of Specialist Supportive Clinical Management (SSCM) for children and adolescents aged 13-17 years with anorexia nervosa or atypical anorexia nervosa receiving outpatient treatment at the Stockholm Centre for Eating Disorders. SSCM may be offered when other recommended treatments, such as Family-Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E), are not considered suitable.
The primary aim is to evaluate the feasibility and adherence of SSCM for children and adolescents, including treatment completion and attendance. The study will also explore preliminary treatment effects, including changes in eating disorder symptoms, weight, psychological symptoms, and functioning. Participants and their caregivers will complete assessments before, during, and after treatment, with a follow-up three months after treatment completion. Patients and caregivers will also be invited to participate in qualitative interviews at the end of treatment to explore their experiences of SSCM.
This is a single-group open feasibility study evaluating an adaptation of Specialist Supportive Clinical Management (SSCM) for children and adolescents with anorexia nervosa or atypical anorexia nervosa. The intervention is intended for patients for whom other recommended treatments, such as Family-Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E), are not considered suitable or have not been effective.
SSCM is delivered as an outpatient treatment at the Stockholm Centre for Eating Disorders and typically consists of approximately 25 sessions, or up to 40 sessions for patients with more severe conditions and comorbidity, delivered on average once per week. The treatment includes individual work with the child/adolescent, involvement of parents or caregivers when appropriate, and monitoring of physical health. The clinical management component focuses on establishing regular and adequate eating patterns and, when needed, weight restoration. The supportive component provides space for the child/adolescent to raise and discuss topics of personal importance, guided by their own agenda. Therapists are trained in SSCM and receive supervision.
The primary focus of the study is feasibility and adherence to treatment. Preliminary treatment effects are also evaluated by examining changes in eating disorder and other psychological symptoms, weight, functioning, and skills. Quantitative data are collected from adolescents and caregivers (self-report), and clinicians (CGAS and BMI) at baseline (treatment week 1), at treatment completion (after 25 weeks for standard treatment, or 40 weeks for severe conditions with comorbidity), and three months after treatment completion. Patients also complete two ED questionnaires at week 13 in standard treatment and week 20 in treatment for severe conditions with comorbidity. In addition, a brief ED questionnaire (EDSL) is completed every fifth week during treatment.
At treatment completion, children/adolescents and parents/caregivers are also invited to participate in qualitative interviews about their experiences of SSCM, helpful aspects, and potential challenges. The qualitative evaluation is intended to provide additional information about the acceptability and experience of the treatment and to inform further development of SSCM for adolescents. Interview data will be analyzed thematically to identify recurring patterns and themes.
462 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 30 is below the median of 43 across 311 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive Specialist Supportive Clinical Management (SSCM) adapted for children and adolescents, delivered as outpatient treatment for anorexia nervosa or atypical anorexia nervosa.
Behavioral: Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth)
SSCM-Youth is an adaptation of Specialist Supportive Clinical Management for children and adolescents with anorexia nervosa or atypical anorexia nervosa. The treatment is delivered in an outpatient setting and typically consists of approximately 25 sessions, or 40 sessions for patients with more severe conditions, held once or twice weekly. It combines clinical management of the eating disorder with supportive psychotherapy and includes monitoring of physical health. Parents or caregivers are involved when appropriate. Therapists are trained in SSCM and receive supervision.
Treatment completion
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.
Time frame: 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).
Treatment adherence
Number and proportion of planned SSCM-Youth treatment sessions attended by participants.
Time frame: 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).
Patients' and Parents' or Legal Guardians' Experiences of SSCM
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.
Time frame: 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.
Change in body mass index (BMI)
Body mass index (BMI; kg/m²) will be assessed to evaluate preliminary changes in weight status during treatment and follow-up.
Time frame: 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.
Change in eating disorder psychopathology
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.
Time frame: 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.
Change in Eating Disorder-Related Psychosocial Impairment (CIA)
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.
Time frame: 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.
Change in Anxiety and Depressive Symptoms (RCADS)
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: 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.
Change in Difficulties in Emotion Regulation (DERS-16)
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.
Time frame: 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.
Change in Social Safeness and Pleasure (SSPS)
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.
Time frame: 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.
Change in Deliberate Self-Harm (DSHI-9)
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).
Time frame: 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.
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: 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.
Change in Parent-Reported Anorectic Behaviors (ABOS)
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: 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.
Change in Parent-Reported Emotional and Behavioral Difficulties (SDQ)
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.
Time frame: 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.
Parent-Reported Treatment Credibility and Expectancy (CEQ)
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.
Time frame: Assessments: 1) at baseline, i.e. treatment week 1. Only parents.
Parent-Reported Treatment Satisfaction (TSS-2)
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.
Time frame: 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.
Brief, repeated assessment of eating disorder symptoms
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.
Time frame: 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.
CGAS - Children's Global Assessment Scale
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.
Time frame: 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.
Plan to share: No — Individual participant data are not planned to be shared due to the small sample size and the sensitive nature of the clinical data.
No publications or documents are linked to this record.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.