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Anorexia NervosaSSCM-YouthNCT07893145

Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa

A study testing Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth) in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by Karolinska Institutet at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Anorexia Nervosa, Atypical Anorexia Nervosa
What is being tested?
Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSweden
Study dates
15 May 2026to 31 Dec 2027
Phase
Interventional
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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 12-17 years.
  • Diagnosis of anorexia nervosa or atypical anorexia nervosa.
  • Insufficient improvement following Family-Based Treatment (FBT) or Cognitive Behavioral Therapy (CBT), or inability to initiate FBT or CBT.
  • Eligible for outpatient treatment.
  • Informed consent provided according to applicable procedures.

Who cannot join

  • Medical or psychiatric condition requiring a level of care that precludes outpatient treatment.
  • Insufficient ability to understand Swedish or cognitive limitations that preclude participation in the treatment or completion of study questionnaires and assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Helena Erneroth-Hanell, Other contact

+46812349322

helena.erneroth-hanell@regionstockholm.se

Sweden1 site, 1 recruiting
  • Stockholm Centre for Eating Disorders

    Stockholm

    Helena Erneroth-Hanell, other, +46812349322, helena.erneroth-hanell@regionstockholm.se

    Martina Wolf-Arehult, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: National Highly Specialized Care for Children With Severe Treatment-Refractory Self-Harm and Eating Disorders: Mapping, Development, and Evaluation - Substudy 3, Evaluation of Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa

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.

Read the detailed description

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.

Being tested
Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth)
Keywords
Specialist Supportive Clinical Management, SSCM, Eating Disorders, Feasibility, Psychotherapy, Children and Adolescents
Medical subject headings
Anorexia Nervosa, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth)Behavioural

    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.

Study groups in NCT07893145
Study groupRoleWhat they receive
SSCM-YouthExperimentalParticipants receive Specialist Supportive Clinical Management (SSCM) adapted for children and adolescents, delivered as outpatient treatment for anorexia nervosa or atypical anorexia nervosa.
Receives: Behavioral: Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. Treatment adherence

    Number and proportion of planned SSCM-Youth treatment sessions attended by participants.

    Measured: 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).

  3. 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.

    Measured: 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.

Secondary outcomes (10)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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).

    Measured: 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.

  8. 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: 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.

  9. 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

    Measured: 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.

  10. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2026
  2. Study start15 May 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07893145
Sponsor's protocol ID
SSCM-YOUTH
Acronym
SSCM-Youth
Status last verified
Oct 2026
First submitted
9 Oct 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be shared due to the small sample size and the sensitive nature of the clinical data.

Questions about this trial

What is this clinical trial studying?

A study testing Specialist Supportive Clinical Management for Children and Adolescents (SSCM-Youth) in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by Karolinska Institutet at 1 site 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 5 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 23 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 1 site 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 Helena Erneroth-Hanell, Other (+46812349322, helena.erneroth-hanell@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment completion (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).). 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 23 Oct 2026.

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