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

NCT ID: NCT06792227

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-04-01

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.

Conditions

Eating Disorders; Anorexia Nervosa; Eating Disorder Not Otherwise Specified

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FBT-H

Intervention Type: 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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karakter Kinder- en Jeugdpsychiatrie

OTHER

Sponsor Role: lead

Responsible Party

Rik Knipschild

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karakter

Almelo, Overijssel, Netherlands

Countries

Netherlands

References

Schapink AAH, van der Velde J, Winkelhorst K, Kaijadoe S, Elgersma HHJ, Grange DL, 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.

Reference Type: DERIVED

PMID: 40200161 (View on PubMed)

Other Identifiers

210-21

Identifier Type: -

Identifier Source: org_study_id