Anorexia in AdolescenceSpor3NCT06097247
Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa
An observational study of Anorexia in Adolescence and Anorexia in Children, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Anorexia in Adolescence, Anorexia in Children, Family Relations
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 1 Aug 2027
- Phase
- Observational
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All eligible patients presenting for treatment in the region are invited to participate.
Who may be able to join
- Diagnosis of F50.0 or F50.1 first time of treatment with family-based treatment living with a minimum of one parent informed consent from young person and parents
Who cannot join
- non Danish-speaking
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Child and Adolescent Mental Health Care Center
Copenhagen, DK-2400
About this study
Official title: Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa. User Perspectives and Observed Changes - a Mixed Method Explorative Study Designed to Inform a Clinical Trial Testing Treatment Improvements
The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.
Read the detailed description
Background:
Family-based treatment (FBT) for anorexia nervosa (AN) in children and youth has contributed significantly to the treatment of a disorder that has otherwise had a poor prognosis. Focus in FBT is on empowering parents to take full control over their child's nourishment. However, many parents are concerned how FBT might affect the relationship with their child as parents assume a double role of insisting on eating and weight gain, while at the same time providing emotional support, when this distresses the child. Moreover, FBT may have a "blind eye" to psychological difficulties with e.g. emotion regulation and interpersonal challenges, and thus inadvertently exacerbating them while focusing narrowly on eating and weight gain.
Aim:
The aim of the study is to quantitatively investigate side-effects of FBT by:
- Assessing average changes as well as variations across families from start of FBT, after 3 months, and at end of FBT in four domains: perceived parental stress level and family function, emotion regulation ability and perceived attachment to parents.
- Qualitatively describe the lived experience of young persons as well as parents going through FBT.
- Based on the results of a) and b) to generate hypotheses on which additions and / or alterations to treatment that may mitigate potential adverse side effects of FBT- treatment. These modifications to FBT will be tested in a future clinical trial.
Exploratively, we will investigate whether level of family functioning at three months of FBT predicts changes in the four above mentioned domains at end of treatment (EOT), thus identify early in treatment the families at risk of adverse side-effects of FBT.
Methods:
Family functioning, parental stress level and attachment perception are measured with questionnaires only. Emotion regulation is measured with questionnaires and the Tangram Puzzle Task. The qualitative section of the study consists of interviews at end of treatment and will be conducted in a co-operation with the Danish patient organization Eating Disorders and Self Harm.
The project is a sub study to the larger study investigating response to treatment of eating disorders in youth: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service (CAMHS) for Children and Adolescents With Eating Disorders (VIBUS).
What is being measured
The primary outcome is the main question the study is designed to answer.
The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).
Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.
Measured: Start and End of Treatment (an average of 1 year).
The Kerns Security Scale-Revised 21
Minimum value: 1 Maximum value: 4 Higher scores indicate more secure attachment.
Measured: Start and End of Treatment (an average of 1 year).
Difficulties in Emotion Regulation Scale (DERS)
Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.
Measured: Start and End of Treatment (an average of 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Feb 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia in AdolescenceStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foreningen Spiseforstyrrelser og Selvskade
- Responsible party
- Sponsor
- Investigators
- Anne Katrine Pagsberg, professor, Principal investigator, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097247
- Sponsor's protocol ID
- H-21041874
- Acronym
- Spor3
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa. User Perspectives and Observed Changes - a Mixed Method Explorative Study Designed to Inform a Clinical Trial Testing Treatment Improvements
- ClinicalTrials.gov ID
- NCT06097247
- Acronym / sponsor ID
- Spor3 / H-21041874
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Foreningen Spiseforstyrrelser og Selvskade
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Oct 2023 (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 study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.
Detailed description
Background:
Family-based treatment (FBT) for anorexia nervosa (AN) in children and youth has contributed significantly to the treatment of a disorder that has otherwise had a poor prognosis. Focus in FBT is on empowering parents to take full control over their child's nourishment. However, many parents are concerned how FBT might affect the relationship with their child as parents assume a double role of insisting on eating and weight gain, while at the same time providing emotional support, when this distresses the child. Moreover, FBT may have a "blind eye" to psychological difficulties with e.g. emotion regulation and interpersonal challenges, and thus inadvertently exacerbating them while focusing narrowly on eating and weight gain.
Aim:
The aim of the study is to quantitatively investigate side-effects of FBT by:
- Assessing average changes as well as variations across families from start of FBT, after 3 months, and at end of FBT in four domains: perceived parental stress level and family function, emotion regulation ability and perceived attachment to parents.
- Qualitatively describe the lived experience of young persons as well as parents going through FBT.
- Based on the results of a) and b) to generate hypotheses on which additions and / or alterations to treatment that may mitigate potential adverse side effects of FBT- treatment. These modifications to FBT will be tested in a future clinical trial.
Exploratively, we will investigate whether level of family functioning at three months of FBT predicts changes in the four above mentioned domains at end of treatment (EOT), thus identify early in treatment the families at risk of adverse side-effects of FBT.
Methods:
Family functioning, parental stress level and attachment perception are measured with questionnaires only. Emotion regulation is measured with questionnaires and the Tangram Puzzle Task. The qualitative section of the study consists of interviews at end of treatment and will be conducted in a co-operation with the Danish patient organization Eating Disorders and Self Harm.
The project is a sub study to the larger study investigating response to treatment of eating disorders in youth: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service (CAMHS) for Children and Adolescents With Eating Disorders (VIBUS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All eligible patients presenting for treatment in the region are invited to participate.
Key inclusion criteria (1 listed)
- Diagnosis of F50.0 or F50.1 first time of treatment with family-based treatment living with a minimum of one parent informed consent from young person and parents
Key exclusion criteria (1 listed)
- non Danish-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).
Time frame: Start and End of Treatment (an average of 1 year).
Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.
The Kerns Security Scale-Revised 21
Time frame: Start and End of Treatment (an average of 1 year).
Minimum value: 1 Maximum value: 4 Higher scores indicate more secure attachment.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Start and End of Treatment (an average of 1 year).
Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anne Katrine Pagsberg, professor principal investigator
Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia in Adolescence and Anorexia in Children, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 Denmark. 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?
The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15). (time frame: Start and End of Treatment (an average of 1 year).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.