Enrolling by invitation NCT06792227

Family-Based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions

No phase Interventional Eating Disorders Anorexia Nervosa Eating Disorder Not Otherwise Specified

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: FBT-H.
Who it may be relevant to: Registry conditions: Eating Disorders, Anorexia Nervosa, Eating Disorder Not Otherwise Specified. Basic parameters: 12 years — 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Netherlands
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Official title

Family-based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions

Overview

The significant impact of eating disorders on adolescents necessitates the evaluation of current treatments. Family-based Treatment (FBT) is the standard treatment but has modest remission rates, highlighting the need for improvements. Assessing its effectiveness in adolescents with co-occurring mental health conditions is also crucial. In the Netherlands, there is a growing focus on home-based treatment. This study aims to enhance remission rates in FBT by adapting it for use in a home setting (FBT-H).

Detailed description

Background:

Objective:

This mixed-method study combines single case studies with qualitative research. The primary objective is to assess the effects and experiences of FBT-H in adolescents with eating disorders and co-occurring mental health conditions across variables such as weight, eating disorder symptoms, anxiety, mood, well-being, quality of life, and family dynamics. Additionally, it explores the experiences of adolescents, parents, and practitioners with FBT-H.

Methods:

Adolescents (12-18 years old) with anorexia nervosa (AN) or other specified feeding or eating disorders (OSFED), alongside co-occurring mental health conditions, will participate in FBT-H, attending about two home sessions per week for 6-12 months. Ten patients will be monitored with intensive measurements over one year. Baseline assessments include somatic screening, clinical interviews, and evaluations of mood, anxiety, and family dynamics. The primary outcome is weight change from baseline to one year post treatment, and secondary outcomes (e.g., eating disorder symptoms, quality of life, parent-child relationships, and caregiving burden) are assessed at baseline and then every three months. General well-being and therapeutic relationships are tracked weekly. One-year post treatment, somatic health, and mood/anxiety symptoms will be reassessed alongside qualitative interviews with adolescents, parents, and practitioners.

Interventions

Behavioral FBT-H
FBT is a structured treatment lasting 6-12 months, typically in an outpatient setting, with weekly sessions that gradually decrease in frequency over time (Lock \& Le Grange, 2015). It empowers parents to manage their child's recovery from the ED. The first phase focuses on weight restoration, with parents responsible for all eating decisions and restricting physical activity to reduce ED's influence. In the second phase, eating responsibility gradually shifts back to the adolescent. The final p

Primary outcome measures

Weight [Time frame: Each session (week 1 - week 52, through study completion)]

Secondary outcome measures (6)

Outcome Rating Scale [Time frame: Each session (week 1 - week 52, through study completion)]
Session Outcome Rating Scale [Time frame: Each session (week 1 - week 52, through study completion)]
Eating Disorder Examination Questionnaire [Time frame: Adolescents in this study will complete the EDE-Q five times (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) . It takes 10 minutes to complete the questionnaire.]
Quality of Life [Time frame: Adolescents and their parents are asked to complete this questionnaire five times (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) and it requires 10 minutes to complete.]
Parent-Child Interaction Questionnaire-Revised [Time frame: The OKIV-R is administered a total of five times to both adolescents and their parents (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) . The duration to complete the questionnaire is approximately10 minutes.]
Parenting Burden Questionnaire (Opvoedingsbelasting Vragenlijst (OBVL) [Time frame: The OBVL is administered a total of five times to parents participating in this study (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) , and it requires 15 minutes of their time.]

Eligibility criteria

Inclusion criteria

adolescents aged 12 to 18 years;
meeting the criteria for AN or other specified feeding or eating disorder (OSFED);
presence of co-occurring mental health conditions;
sufficient command of the Dutch language by adolescents and parents;
the family supports the treatment as a supportive system and is open to participating in the research.

Exclusion criteria

acute suicidal behaviour requiring hospitalization within the 4 weeks prior to assessment for this study;
cognitive limitations (IQ < 70);
participation of a sibling in the current study (to prevent transfer of therapy effects between siblings);
the adolescent does not receive tube feeding at the start of FBT-H and/or is not hospitalized due to an eating disorder at the start of treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

Netherlands · 1 center

Karakter — Almelo

Publications

Schapink AH, van der Velde J, Winkelhorst K, Kaijadoe S, Elgersma HJ, Le Grange D, Knipschild R, Klip H. Family-based treatment at home in adolescents with eating disorders and co-occurring mental health conditions: rationale and study design of a mixed methods trial. BMC Psychiatry. 2025 Apr 8;25(1):346. doi: 10.1186/s12888-025-06672-z. PMID 40200161

Identifiers

NCT: NCT06792227 · 210-21

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗