Меню
Набор по приглашению NCT06792227

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

Без фазы С лечением Eating Disorders Anorexia Nervosa Eating Disorder Not Otherwise Specified

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FBT-H.
Кому может быть актуально
Состояния в реестре: Eating Disorders, Anorexia Nervosa, Eating Disorder Not Otherwise Specified. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

Background:

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).

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Weight [Срок оценки: Each session (week 1 - week 52, through study completion)]
Вторичные конечные точки (6)
  • Outcome Rating Scale [Срок оценки: Each session (week 1 - week 52, through study completion)]
  • Session Outcome Rating Scale [Срок оценки: Each session (week 1 - week 52, through study completion)]
  • Eating Disorder Examination Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • Karakter — Almelo

Публикации

  • 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

Идентификаторы

NCT: NCT06792227 · 210-21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗