NCT Number: NCT07178977
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.
Trial opening soon.
Get Notified11 year–19 year
All sexes
Interventional
Not applicable
Ljubljana, Slovenia
Eva Brvar
SUB_INVESTIGATOR
Iza Košir
SUB_INVESTIGATOR
Jana Kodrič, PhD
SUB_INVESTIGATOR
Kaja Hacin Beyazoglu, PhD
SUB_INVESTIGATOR
Katja Kurnik Mesarič
SUB_INVESTIGATOR
Marija Anderluh, PhD
SUB_INVESTIGATOR
Melita Bokalič
SUB_INVESTIGATOR
Tjaš Debeljak
SUB_INVESTIGATOR
Žiga Damjanac
CONTACT
Žiga Damjanac
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 supporting normal eating patterns, Promoting and sustaining change.
The program is adapted from evidence-based approaches, including family-based treatment (FBT) and enhanced cognitive-behavioral therapy (CBT-E), and is tailored to a psychoeducational group format for parents. The aim is to reduce parental distress, improve coping, and enhance adolescent treatment outcomes (BMI, eating disorder symptoms, anxiety, depression).
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Body weight and height will be measured and BMI will be calculated (kg/m²). Change in BMI will be assessed as an indicator of treatment response.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Self-reported eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire, Version 6.0 (EDE-Q 6.0). The questionnaire includes four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern, and produces a global score. Each item is rated on a 7-point scale (0-6), where higher scores indicate more severe eating disorder symptoms. The global score is the average of all items, with 0 representing no symptoms and 6 representing the most severe level of symptoms.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Self-reported symptoms of anxiety and depression will be assessed using the Revised Child Anxiety and Depression Scale (RCADS). The questionnaire consists of 47 items, each rated on a 4-point scale (0-3), where 0 = never, 1 = sometimes, 2 = often, and 3 = always. Higher scores indicate greater severity of anxiety or depression symptoms.
The RCADS includes six subscales: Separation Anxiety, Social Phobia, Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, and Depression, as well as total anxiety and total internalizing scores.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Self-reported symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The questionnaire consists of 14 items, with 7 items assessing anxiety and 7 items assessing depression. Each item is rated on a 4-point scale (0-3), where 0 represents no symptoms and 3 represents the most severe level of symptoms. Higher scores indicate greater severity of anxiety or depression.
Each subscale (Anxiety and Depression) has a total score range of 0-21, with higher scores reflecting worse psychological distress.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). The questionnaire consists of 10 items, each rated on a 5-point scale (0-4), where 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, and 4 = very often. Higher scores indicate greater perceived stress.
The total score ranges from 0 to 40, with 0 representing no perceived stress and 40 representing the highest level of perceived stress.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
General self-efficacy will be assessed using the General Self-Efficacy Scale (GSE). The questionnaire consists of 10 items, each rated on a 4-point scale (1-4), where 1 = not at all true, 2 = hardly true, 3 = moderately true, and 4 = exactly true.
The total score ranges from 10 to 40, with higher scores indicating greater perceived self-efficacy, reflecting a better outcome.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Perceived social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). The questionnaire consists of 12 items, each rated on a 7-point scale (1-7), where 1 = very strongly disagree and 7 = very strongly agree.
The total score ranges from 12 to 84, with higher scores indicating greater perceived social support, which reflects a better outcome. The MSPSS also provides subscale scores for support from family, friends, and significant others.
Time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Parent-reported symptoms of adolescent anxiety and depression will be assessed using the Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P). The questionnaire consists of 47 items, each rated on a 4-point scale (0-3), where 0 = never, 1 = sometimes, 2 = often, and 3 = always. Higher scores indicate greater severity of adolescent anxiety or depression symptoms as perceived by parents.
The RCADS-P provides six subscale scores: Separation Anxiety, Social Phobia, Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, and Depression, as well as total anxiety and total internalizing scores.
Contact information is provided by the study sponsor or research team.
University Medical Centre Ljubljana
Other
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