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. 2024 Nov 13;25(1):760.
doi: 10.1186/s13063-024-08566-z.

Anorexia nervosa-specific home treatment in children and adolescents and their families (the HoT study): a study protocol of a randomized, controlled, multicenter, open-label, parallel group superiority trial

Brigitte Dahmen  1 , Ingar Zielinski-Gussen  2 , Manuel Föcker  3   4 , Freia Hahn  5 , Tanja Legenbauer  4 , Ulf Thiemann  6 , Astrid Dempfle  7 , Beate Herpertz-Dahlmann  2
Affiliations

Anorexia nervosa-specific home treatment in children and adolescents and their families (the HoT study): a study protocol of a randomized, controlled, multicenter, open-label, parallel group superiority trial

Brigitte Dahmen et al. Trials. .

Abstract

Background: New treatment approaches are urgently needed to improve the prognosis of children and adolescents with anorexia nervosa (AN). Recently, the feasibility of multidisciplinary home treatment that strongly involves the patients' parents/caregivers has been investigated. However, no RCT has yet been performed to test the efficacy and safety of this approach compared to standard treatment approaches, such as inpatient treatment.

Methods: In this multicenter randomized-controlled trial, home treatment for children and adolescents with AN aged 12 to 18 years is established at 5 major treatment centers for AN in Germany. Approximately 240 patients who are admitted to the hospital for AN will be included in the trial. After a short inpatient somatic stabilization phase (5-8 weeks), patients are randomized to receive either treatment as usual (TAU), in the form of continued inpatient or day patient treatment, or the newly developed home treatment (HoT) (n = 82/arm, n = 164 in total). There are three assessments throughout treatment (admission, randomization, and discharge), as well as follow-up assessments at 9 and 12 months after admission. The BMI at 12 months after admission (primary outcome) is compared between groups (adjusted for premorbid BMI and admission BMI); secondary outcomes include eating disorder and general psychopathology, the number and duration of psychiatric rehospitalizations, quality of life, motivation for treatment and treatment satisfaction. Other secondary outcomes include the primary caregivers' burden and skills in handling the child's illness and direct treatment costs. Statistical analysis will be based on intention-to-treat principles, using mixed models for repeated measures. (Serious) adverse events are assessed throughout treatment. In addition, the feasibility and implementation of HoT as well as the satisfaction and workload of the members of the multidisciplinary treatment teams in both arms will be assessed.

Discussion: In the case of a positive evaluation, HoT can be considered an effective treatment method to replace or complete established treatment methods, such as IP, for treating AN in children and adolescents. The home treatment setting might shorten inpatient stays in this patient group, increase treatment satisfaction, and help to reduce the risk of rehospitalization, which is associated with a better outcome in this vulnerable patient group.

Trial registration: The trial was registered with the German Clinical Trial Register (DRKS) under the ID DRKS00025925 on November 26, 2021 (prospectively registered): https://drks.de/search/de/trial/DRKS00025925 .

Keywords: Adolescents; Anorexia nervosa; Health services research; Home treatment; Stepped-care.

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Conflict of interest statement

Declarations Ethics approval and consent to participate Ethics approval was granted via a coordinated procedure lead by the Ethic board of the University Hospital RWTH Aachen (reference number for all centers: EK 323/21) for all ethics committees of the involved clinical centers: the Ethic boards of the University Hospital RWTH Aachen (reference: 323/21), the University Hospital Muenster (local registration number: 2021–572-b-S), the University Hospital Ruhr-University Bochum (local registration number: 21–7367-BR), and of the North Rhine State Chamber of Physicians (ÄkNo) (for LVR Hospital Viersen and LVR Hospital Bonn, local reference number: 2021346). Written informed consent is obtained from all young patients and their parents/legal guardians. The study is undertaken in accordance with the Declaration of Helsinki, the ICH E6 Guidelines for Good Clinical Practice (GCP), local rules, regulations, and applicable requirements with independent data management. Consent for publication Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests Tanja Legenbauer: Royalties by various publishers such as Hogrefe, Springer, and Kohlhammer for treatment manuals on eating disorders and body image disorder, research grants from the German Ministry for Research and Education.Beate Herpertz-Dahlmann: Research grants from the German Research Society, the German Ministry for Research and Education, EU/ERA NET and the Gemeinsamer Bundesausschuss (federal joint committee), author’s honorary from Kohlhammer publisher, speaker’s honorary from Infectopharm and Editor-in-Chief honorary from Wiley.The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Diagram of patient flow in the RCT. Home treatment (HoT) versus treatment as usual (TAU). Abbr.: IP—inpatient treatment; incl.—including
Fig. 2
Fig. 2
Schedule of enrollment, interventions, assessments, and measures of the RCT and patient data. Abbreviations: HoT – home treatment, TAU – treatment as usual, BMI – body mass index, EDE—Eating Disorder Examination Interview, EDI-2—Eating Disorder Inventory 2, MROAS—Morgan Russel Average Outcome Score, ANSOCQ—Anorexia Nervosa Stages of Change Questionnaire, MINI-KID—Mini-International Neuropsychiatric Interview for Children and Adolescents, BDI-II—Beck Depression Inventory 2, CGAS/GAF—Children’s Global Assessment Scale/Global Assessment of Functioning, ZUF—Satisfaction with treatment, FTB-KJ—Therapeutic Alliance Scale for Children, AE—adverse events, SAE—serious adverse events, AESED—Accommodation and Enabling Scale for Eating Disorders, CASK—Caregiver Skills, EDSIS—Eating Disorders Symptom Impact Scale [–52]
Fig. 3
Fig. 3
Appointment schedule of HoT. Abbr.: M—Monday; TUE—Tuesday; W—Wednesday; TH—Thursday; F—Friday; AN—Anorexia nervosa
See this image and copyright information in PMC

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