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

Sponsor
Mental Health Services in the Capital Region, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT06097247
Collaborator
Foreningen Spiseforstyrrelser og Selvskade (Other)
60
1
42
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Family function [through treatment completion an average of 1 year]

      The Score Family Assessment Questionnaire-15

    2. Perceived attachment [through treatment completion an average of 1 year]

      The Kerns Security Scale-Revised 21

    3. Emotion regulation [through treatment completion an average of 1 year]

      Difficulties in Emotion Regulation Scale 36

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Child and Adolescent Mental Health Care Center Copenhagen Denmark DK-2400

    Sponsors and Collaborators

    • Mental Health Services in the Capital Region, Denmark
    • Foreningen Spiseforstyrrelser og Selvskade

    Investigators

    • Principal Investigator: Anne Katrine Pagsberg, professor, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mental Health Services in the Capital Region, Denmark
    ClinicalTrials.gov Identifier:
    NCT06097247
    Other Study ID Numbers:
    • H-21041874
    First Posted:
    Oct 24, 2023
    Last Update Posted:
    Oct 24, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 24, 2023