Evidence map›Paper›PMID 39538317›Full record

ArticleTrials2024

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, Ingar Zielinski-Gussen, Manuel Föcker, Freia Hahn, Tanja Legenbauer, Ulf Thiemann, Astrid Dempfle, Beate Herpertz-Dahlmann

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

8 authors.

Brigitte DahmenDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, RWTH Aachen University, Neuenhofer Weg 21, 52074, Aachen, Germany. bdahmen@ukaachen.de.ORCID http://orcid.org/0000-0003-3079-7666
Ingar Zielinski-GussenDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, RWTH Aachen University, Neuenhofer Weg 21, 52074, Aachen, Germany.
Manuel FöckerDepartment of Child and Adolescent Psychiatry, University Hospital Münster, Schmeddingstraße 50, 48149, Münster, Germany.
Freia HahnDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LVR Clinic Viersen, Horionstraße 14, 41749, Viersen, Germany.
Tanja LegenbauerLWL University Hospital Hamm for Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic, Ruhr-University Bochum, Heithofer Allee 64, 59071, Hamm, Germany.
Ulf ThiemannDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LVR Hospital Bonn, Kaiser- Karl-Ring 20, 53111, Bonn, Germany.
Astrid DempfleInstitute of Medical Informatics and Statistics, Kiel University and University Hospital Schleswig-Holstein, Brunswiker Str. 10, 24105, Kiel, Germany.
Beate Herpertz-DahlmannDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, RWTH Aachen University, Neuenhofer Weg 21, 52074, Aachen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew 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.

methodsIn 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 registrationThe 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 .

Indexed as

Anorexia NervosaEquivalence Trials as TopicMulticenter Studies as TopicAdolescentAdolescent BehaviorAge FactorsCaregiversChildChild BehaviorCost-Benefit AnalysisFamily TherapyFemaleGermanyHome Care ServicesHome Care Services, Hospital-BasedHumansAdolescentsAnorexia nervosaHealth services researchHome treatmentStepped-care

Identifiers

PMID39538317
PMCPMC11559055

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.