Family-based Treatment At Home in Adolescents with Eating Disorders and Co-occurring Mental Health Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Weight
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mixed Methods Design
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.
Intervention: FBT-H (Behavioral)
Outcomes
Primary Outcomes
Weight
Time Frame: Each session (week 1 - week 52, through study completion)
Weight - each session The weight of the adolescent in kilograms (kg) is measured weekly to monitor progress. The weight is measured by an FBT-H practitioner in an FBT-H session. The weight is measured in the same way every week (e.g., in underwear). This is a standard measurement associated with the FBT intervention and takes approximately 5 minutes.
Secondary Outcomes
- Outcome Rating Scale(Each session (week 1 - week 52, through study completion))
- Session Outcome Rating Scale(Each session (week 1 - week 52, through study completion))
- Eating Disorder Examination Questionnaire(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(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(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)(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.)
Investigators
Rik Knipschild
PhD
Karakter Kinder- en Jeugdpsychiatrie