Clinical trial NCT06792227: Family-Based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions
Official title: Family-based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Keywords: Family Based Treatment
Youth
Eating Disorders
Anorexia Nervosa
Family Based Treatment at Home
FBT-H
FBT
Lead sponsor: Karakter Kinder- en Jeugdpsychiatrie
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: To evaluate the effectiveness of FBT-H, we implemented a mixed-method approach combining a single-case design and a qualitative study. In the single-case design, 10 cases are intensively monitored throughout the FBT-H process, documenting interventions and their effects. The qualitative study complements this by gathering insights from adolescents, parents, and professionals about their experiences with FBT-H using structured interviews conducted separately with each group post-treatment to explore key topics. Together, these methods provide a comprehensive understanding of the impact of FBT-H.
Primary purpose: TREATMENT

Brief summary: 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:

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.

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.

Primary outcomes:
measure: Weight
timeFrame: Each session (week 1 - week 52, through study completion)
Secondary outcomes:
measure: Outcome Rating Scale
timeFrame: Each session (week 1 - week 52, through study completion)
measure: Session Outcome Rating Scale
timeFrame: Each session (week 1 - week 52, through study completion)
measure: Eating Disorder Examination Questionnaire
timeFrame: 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.
measure: Quality of Life
timeFrame: 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.
measure: Parent-Child Interaction Questionnaire-Revised
timeFrame: 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.
measure: Parenting Burden Questionnaire (Opvoedingsbelasting Vragenlijst (OBVL)
timeFrame: 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.
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Karakter
state: Overijssel
Study officials:
References: