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

Family Relations Clinical Trial

— Spor3  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097247
• Other study ID #: H-21041874
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Signe Holm Pedersen, phd
• Phone: +4526132045
• Email: signe.holm.pedersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

1. 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.

2. Qualitatively describe the lived experience of young persons as well as parents going through FBT.

3. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia in Adolescence
• Anorexia in Children
• Anorexia Nervosa
• Family Relations

Locations

Country	Name	City	State
Denmark	Child and Adolescent Mental Health Care Center	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Foreningen Spiseforstyrrelser og Selvskade

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).	Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.	Start and End of Treatment (an average of 1 year).
Primary	The Kerns Security Scale-Revised 21	Minimum value: 1 Maximum value: 4 Higher scores indicate more secure attachment.	Start and End of Treatment (an average of 1 year).
Primary	Difficulties in Emotion Regulation Scale (DERS)	Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.	Start and End of Treatment (an average of 1 year).