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

NCT07178977 | Not Yet Recruiting

• 1 other identifier: PPO-ZD-MH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eating Disorders; Anorexia Nervosa

Keywords

eating disorders; Anorexia Nervosa; Parental Stress; Parental Coping

Outcome Measures

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.

  Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).

Secondary Outcomes (7)

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

  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)

  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)

  Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).

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

  Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).

• Change in Parental Self-Efficacy - General Self-Efficacy Scale (GSE)

  Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).

Study Arms (2)

Experimental: Psychoeducation for parents of adolescents with anorexia nervosa

EXPERIMENTAL

Parents in the intervention group will participate in a structured four-week psychoeducation program designed to support families of adolescents with anorexia nervosa. The program consists of four weekly group sessions, each lasting 90 minutes, delivered at the Child Psychiatry Department, University Medical Centre Ljubljana. Each session follows a standardized format: (1) review of homework and discussion of experiences, (2) introduction of the session content, (3) structured psychoeducational module, and (4) assignment of new tasks.

Behavioral: Psychoeducation group

Waitlist control group

ACTIVE COMPARATOR

Parents in the waitlist control group will continue with treatment as usual and will not participate in the psychoeducation program during the first month of the study. They will complete baseline and one-month assessments while waiting. After this one-month period, the waitlist group will receive the same structured four-week psychoeducation program as the intervention group.

Behavioral: Psychoeducation group

Interventions

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).

Experimental: Psychoeducation for parents of adolescents with anorexia nervosa; Waitlist control group

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana: collaborator

Study Sites (1)

Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (15)

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MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jana Kodrič, PhD

  Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana

  STUDY DIRECTOR

• Marija Anderluh, PhD

  Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana

  STUDY CHAIR

Central Study Contacts

Žiga Damjanac

CONTACT

+38640251410; ziga.damjanac@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the intervention (Psychoeducation and waitlist groups) makes it impossible to mask interventions assigned.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study will be finished

Locations

SL (1)