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

NCT06792227 | Enrolling By Invitation DMC

• 1 other identifier: 210-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Weight

  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.

  Each session (week 1 - week 52, through study completion)

Secondary Outcomes (6)

• 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.

Study Arms (1)

Mixed Methods Design

EXPERIMENTAL

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.

Behavioral: FBT-H

Interventions

FBT-H BEHAVIORAL

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 phase supports healthy adolescent development as ED symptoms subside. The FBT-H adapts FBT to a home setting, with treatment led by family counselors and psychologists as part of a multidisciplinary team, including therapists, psychologists, a psychiatrist and a nurse specialist.

Mixed Methods Design

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karakter Kinder- en Jeugdpsychiatrie: lead

Study Sites (1)

Karakter

Almelo, Overijssel, 7522, Netherlands

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 24, 2025
• Study Start: November 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)