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Not yet recruiting NCT07178977

Psychoeducation for Parents of Adolescents With Anorexia Nervosa as a Supportive Treatment Approach

No phase Interventional Eating Disorders Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychoeducation group.
Who it may be relevant to
Registry conditions: Eating Disorders, Anorexia Nervosa. Basic parameters: 11 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This randomized controlled trial will evaluate the effectiveness of a structured four-week psychoeducation program for parents of adolescents diagnosed with anorexia nervosa (AN). The program aims to improve parental coping and improve adolescent treatment outcomes. Seventy adolescents with AN (ages 11-19) and their parents will be recruited at the University Medical Centre Ljubljana, Slovenia. Families will be randomly assigned to either an intervention group, receiving immediate psychoeducation, or a waitlist control group, receiving the program after one month. The psychoeducation program consists of four weekly 90-minute sessions covering eating disorder characteristics, maintaining factors, strategies for normal eating, and approaches for supporting change. Primary outcomes include change in adolescent body mass index (BMI) from baseline to post-intervention and three-month follow-up. Secondary outcomes include adolescent symptoms of eating disorders, anxiety, and depression, as well as parental anxiety, depression, stress, social support, and self-efficacy. The study will test whether early, structured parental involvement through psychoeducation improves both adolescent clinical outcomes and parental coping.

Detailed description

Anorexia nervosa (AN) is a severe psychiatric disorder with high morbidity and mortality, typically emerging during adolescence. Effective treatment requires family involvement, yet parents frequently experience high levels of stress, anxiety, guilt, and isolation while supporting their child through treatment. Psychoeducation for parents may reduce parental distress and simultaneously enhance adolescent treatment outcomes, but rigorous randomized trials are limited.

This randomized controlled trial will evaluate a structured four-week psychoeducation program for parents of adolescents diagnosed with anorexia nervosa (AN). The intervention is designed to complement treatment as usual and is based on principles from enhanced cognitive-behavioral therapy for eating disorders (CBT-E) and existing psychoeducational protocols. The program aims to improve parental coping skills, reduce parental psychological distress, and improve adolescent treatment outcomes.

Families will be recruited from the Child Psychiatry Department at the University Medical Centre Ljubljana, Slovenia. After providing informed consent, families will be randomized into either:

Intervention group - parents receive immediate participation in the psychoeducation program while their adolescents continue treatment as usual, or

Waitlist control group - parents continue treatment as usual and receive the program after one month.

Each psychoeducation group will include parents of up to seven adolescents and will meet weekly for four sessions, each lasting 90 minutes. Session structure includes: review of previous homework, introduction of new material, core psychoeducational content, and assignment of new tasks. Topics progress from understanding eating disorder characteristics and myths, to identifying maintaining factors, establishing normal eating patterns, and promoting sustainable behavioral and emotional change.

Both adolescents and parents will complete assessments at defined time points. Adolescents will be evaluated for changes in body mass index (BMI) and self-reported psychological symptoms, while parents will be assessed for anxiety, depression, stress, perceived social support, and self-efficacy. The intervention group will be assessed at baseline, immediately post-intervention, and three months after the program, while the waitlist control group will complete assessments at baseline and one month later, prior to receiving the intervention.

The primary outcome is change in adolescent BMI from baseline to post-intervention. Secondary outcomes include changes in adolescent eating disorder symptoms, anxiety, and depression, as well as parental psychological well-being and coping. The study will use a waitlist-controlled design to isolate the effects of the psychoeducation program and will monitor whether improvements are sustained at three-month follow-up.

The trial is expected to provide evidence on the role of structured parental psychoeducation as an adjunct to standard treatment for adolescent AN and to offer a scalable model for integrating family-focused interventions into child and adolescent mental health services.

Interventions

  • Behavioral Psychoeducation group
    A structured, group-based psychoeducation program designed for parents of adolescents with anorexia nervosa. The intervention consists of four weekly sessions, each lasting 90 minutes, delivered in small groups (up to 7 families) at the Child Psychiatry Department, University Medical Centre Ljubljana. Each session follows a standardized structure. The session topics are: Understanding eating disorders; Maintaining factors in anorexia nervosa and strategies to address them; Establishing and suppo

Primary outcome measures

  • Change in Adolescent Body Mass Index (BMI) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
Secondary outcome measures (7)
  • Change in Eating Disorder Symptoms - Eating Disorder Examination Questionnaire (EDE-Q 6.0) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Change in Anxiety and Depression Symptoms - Revised Child Anxiety and Depression Scale (RCADS - Youth Version) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Change in Parental Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Change in Parental Stress - Perceived Stress Scale (PSS-10) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Change in Parental Self-Efficacy - General Self-Efficacy Scale (GSE) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Change in Parental Perceived Social Support - Multidimensional Scale of Perceived Social Support (MSPSS). [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]
  • Parent-Reported Adolescent Anxiety and Depression - Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) [Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).]

Eligibility criteria

Inclusion criteria

  • Adolescents aged 11-19 years
  • Clinical diagnosis of anorexia nervosa (AN) according to DSM-5 criteria
  • Referred for treatment at the Child Psychiatry Department, Pediatric Clinic, University Medical Centre Ljubljana
  • At least one parent/legal guardian willing to participate in the psychoeducation program
  • Signed informed consent by parent(s) and assent from adolescent

Exclusion criteria

  • Adolescents with severe comorbid psychiatric conditions requiring alternative treatment (e.g., psychosis, severe intellectual disability, active substance dependence)
  • Adolescents or parents unable to understand Slovenian language sufficiently to participate in group sessions or complete questionnaires
  • Families already engaged in a structured psychoeducation or similar parent-support program at the time of recruitment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Slovenia · 1 center
  • Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljublj — Ljubljana

Publications

  • Winn S, Perkins S, Murray J, Murphy R, Schmidt U. A qualitative study of the experience of caring for a person with bulimia nervosa. Part 2: Carers' needs and experiences of services and other support. Int J Eat Disord. 2004 Nov;36(3):269-79. doi: 10.1002/eat.20068. PMID 15478136
  • Macdonald P, Murray J, Goddard E, Treasure J. Carer's experience and perceived effects of a skills based training programme for families of people with eating disorders: a qualitative study. Eur Eat Disord Rev. 2011 Nov-Dec;19(6):475-86. doi: 10.1002/erv.1065. Epub 2010 Dec 28. PMID 22021124
  • Lee H, Desai S, Choi YN. Improvements in Quality of Life and Readiness for Change After Participating in an Eating Disorder Psychoeducation Group: A Pilot Study. Int J Group Psychother. 2024 Jul;74(3):268-303. doi: 10.1080/00207284.2024.2341293. Epub 2024 May 10. PMID 38727719
  • Konstantellou A, Sternheim L, Hale L, Simic M, Eisler I. The experience of intolerance of uncertainty for parents of young people with a restrictive eating disorder. Eat Weight Disord. 2022 May;27(4):1339-1348. doi: 10.1007/s40519-021-01256-8. Epub 2021 Jul 22. PMID 34292530
  • Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3. PMID 16815322
  • Honey A, Boughtwood D, Clarke S, Halse C, Kohn M, Madden S. Support for parents of children with anorexia: what parents want. Eat Disord. 2008 Jan-Feb;16(1):40-51. doi: 10.1080/10640260701773447. PMID 18175232
  • Hillege S, Beale B, McMaster R. Impact of eating disorders on family life: individual parents' stories. J Clin Nurs. 2006 Aug;15(8):1016-22. doi: 10.1111/j.1365-2702.2006.01367.x. PMID 16879546
  • Hibbs R, Rhind C, Leppanen J, Treasure J. Interventions for caregivers of someone with an eating disorder: a meta-analysis. Int J Eat Disord. 2015 May;48(4):349-61. doi: 10.1002/eat.22298. Epub 2014 May 31. PMID 24891101

Identifiers

NCT: NCT07178977 · PPO-ZD-MH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗