Eating DisordersF-EETNCT06792227
Family-Based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions
A study testing FBT-H in people with Eating Disorders and Anorexia Nervosa, run by Karakter Kinder- en Jeugdpsychiatrie at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Eating Disorder Not Otherwise Specified
- What is being tested?
- FBT-H
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Family-based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions
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).
Read the 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.
- Being tested
- FBT-H
- Keywords
- Family Based Treatment, Youth, Eating Disorders, Anorexia Nervosa, Family Based Treatment at Home, FBT-H, FBT
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBT-HBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FBT-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each session (week 1 - week 52, through study completion)
Secondary outcomes (6)
Outcome Rating Scale
The ORS is a questionnaire in which participants indicate how they are doing in four components of their lives: personal, interpersonal, social, and general (Miller et al., 2003); translated by Hafkenscheid et al., 2003). These four components form the four items in this questionnaire, which can be answered on a scale from 0-10. There is a child and adult version of the ORS. A score of more to the left (0) indicates a negative score on the corresponding component, and a score of more to the right (10) indicates a more positive one. The internal consistency, measured by Cronbach's alpha, is .97 (26). Adolescents and their parents participating in this study will be asked to fill out this questionnaire at the beginning of each session, which requires approximately 1 minute.
Measured: Each session (week 1 - week 52, through study completion)
Session Outcome Rating Scale
The SRS is a questionnaire in which adolescents express how they have experienced a session. The four items covered are relationship/contact, goals and topics, approach and method, and overall satisfaction. The SRS has the same setup as the previously mentioned ORS. The internal consistency, measured by Cronbach's alpha, is .88. Adolescents and parents participating in this study will be asked to fill out this questionnaire at the end of each treatment session, which takes approximately 1 minute.
Measured: Each session (week 1 - week 52, through study completion)
Eating Disorder Examination Questionnaire
The EDE-Q is a self-report questionnaire used to assess the behaviours and characteristics of ED. The EDE-Q consists of a global scale (22 items) and four subscales: restraint, eating concern, weight concern, and shape concern. Each question can be answered on a scale from 1 to 6 or with a yes/no response. Satisfactory levels of internal consistency were observed.
Measured: 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
Kidscreen-27 is a questionnaire measuring the quality of life of children in five dimensions: physical well-being, mental well-being, parent relations and autonomy, social support (from peers), and school situation. It consists of 27 questions, each of which has five answer options. Cronbach's alpha for all scales varies between average and good.
Measured: 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 consists of questionnaires that measure how parents view the relationship with their child and how children view the relationship with their parents. The child-mother, child-father, and parent-child versions are available. It has 21 statements, and each statement has five answer options varying from never (1) to always (5). The revised version of the OKIV (OKIV-R) has high internal consistency.
Measured: 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 a questionnaire for parents about experiencing stress in parenting (Veerman et al., 2014).The OBVL consists of five scales (34 questions): parent-child relationship, parenting competence (7), depressive moods (7), role limitations (6), and health complaints (8). Each question has four answers that the parent can choose, varying from do not agree to totally agree. The scales of the OBVL have a reliability between .90 and .96 (McDonald's Omega).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Nov 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karakter Kinder- en Jeugdpsychiatrie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rik Knipschild, Karakter Kinder- en Jeugdpsychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792227
- Sponsor's protocol ID
- 210-21
- Acronym
- F-EET
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to persmissions
Publications
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.
PubMed 40200161
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Treatment at Home in Adolescents With Eating Disorders and Co-occurring Mental Health Conditions
- ClinicalTrials.gov ID
- NCT06792227
- Acronym / sponsor ID
- F-EET / 210-21
- Keywords
- Family Based Treatment, Youth, Eating Disorders, Anorexia Nervosa, Family Based Treatment at Home, FBT-H, FBT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karakter Kinder- en JeugdpsychiatrieUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mixed Methods Design | Experimental | Behavioral: FBT-HTo 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FBT-HFBT 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. | Behavioural | Mixed Methods Design |
Primary outcome
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.
6 secondary outcomes
Outcome Rating Scale
Time frame: Each session (week 1 - week 52, through study completion)
Session Outcome Rating Scale
Time frame: Each session (week 1 - week 52, through study completion)
Eating Disorder Examination Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 40200161Schapink 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.
- Individual participant dataSharing planned: No. Due to persmissions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBT-H in people with Eating Disorders and Anorexia Nervosa, run by Karakter Kinder- en Jeugdpsychiatrie at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Each session (week 1 - week 52, through study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.