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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-19
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychoeducation group

    Behavioral

    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).

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental: Psychoeducation for parents of adolescents with anorexia nervosaExperimental treatment 1 intervention
Group B: Waitlist control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Adolescent Body Mass Index (BMI)

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).

Secondary outcomes

1

Change in Eating Disorder Symptoms - Eating Disorder Examination Questionnaire (EDE-Q 6.0)

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).
2

Change in Anxiety and Depression Symptoms - Revised Child Anxiety and Depression Scale (RCADS - Youth Version)

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).
3

Change in Parental Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)

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).
4

Change in Parental Stress - Perceived Stress Scale (PSS-10)

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).

Other outcomes

Sponsors and contacts

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University Medical Centre Ljubljana

Lead sponsor

University of Ljubljana

Collaborator

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