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NCT Number: NCT06097247

Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child and Adolescent Mental Health Care Center

Copenhagen, DK-2400, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • non Danish-speaking

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Foreningen Spiseforstyrrelser og Selvskade

Registry information

Official study 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

Acronym: Spor3

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 24, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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