Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa (Spor3)

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.

Study Overview

• Status: Recruiting
• Conditions: Family Relations; Anorexia in Adolescence; Anorexia in Children

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:

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Signe Holm Pedersen, phd; Phone Number: +4526132045; Email: signe.holm.pedersen@regionh.dk
• Study Contact Backup: Name: Mette Bentz, phd; Phone Number: +4528692555; Email: mette.bentz@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2400
    • Recruiting
    • Child and Adolescent Mental Health Care Center
    • Contact: Mette Bentz, PhD; Phone Number: +45 38 64 10 35; Email: mette.bentz@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients presenting for treatment in the region are invited to participate.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Foreningen Spiseforstyrrelser og Selvskade
• Investigators: Principal Investigator: Anne Katrine Pagsberg, professor, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: H-21041874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No