NCT07893145

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
May 2026Dec 2027

Study Start

First participant enrolled

May 15, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1.6 years

First QC Date

October 9, 2026

Last Update Submit

October 21, 2026

Conditions

Keywords

Specialist Supportive Clinical ManagementSSCMEating DisordersFeasibilityPsychotherapyChildren and Adolescents

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +5 more secondary outcomes

Other Outcomes (4)

  • Parent-Reported Treatment Credibility and Expectancy (CEQ)

    Assessments: 1) at baseline, i.e. treatment week 1. Only parents.

  • 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.

  • 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.

  • +1 more other outcomes

Study Arms (1)

SSCM-Youth

EXPERIMENTAL

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)

Interventions

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.

SSCM-Youth

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm Centre for Eating Disorders

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martina Wolf-Arehult, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Erneroth-Hanell, Other

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 23, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared due to the small sample size and the sensitive nature of the clinical data.

Locations