Eating DisordersNCT07178977
Psychoeducation for Parents of Adolescents With Anorexia Nervosa as a Supportive Treatment Approach
A study testing Psychoeducation group in people with Eating Disorders and Anorexia Nervosa, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa
- What is being tested?
- Psychoeducation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana
Ljubljana
Žiga Damjanac, +38640251410, ziga.damjanac@kclj.si
Žiga Damjanac
About this study
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.
Read the 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.
- Conditions
- Eating Disorders, Anorexia Nervosa
- Being tested
- Psychoeducation group
- Keywords
- eating disorders, Anorexia Nervosa, Parental Stress, Parental Coping
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation groupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
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.
Measured: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Change in Parental Self-Efficacy - General Self-Efficacy Scale (GSE)
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.
Measured: 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).
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.
Measured: 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)
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.
Measured: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Jana Kodrič, PhD, Study director, Unit of Child Psychiatry, University Children's hospital, University Medical Centre LjubljanaMarija Anderluh, PhD, Study chair, Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178977
- Sponsor's protocol ID
- PPO-ZD-MH
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to publish it on the repository of University of Ljubljana. Personal data will not be provided, participants will be encrypted and unrecognizable.
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.
PubMed 15478136Macdonald 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.
PubMed 22021124Lee 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.
PubMed 38727719Konstantellou 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.
PubMed 34292530Hudson 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.
PubMed 16815322Honey 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.
PubMed 18175232Hillege 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.
PubMed 16879546Hibbs 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.
PubMed 24891101Fursland A, Erceg-Hurn DM, Byrne SM, McEvoy PM. A single session assessment and psychoeducational intervention for eating disorders: Impact on treatment waitlists and eating disorder symptoms. Int J Eat Disord. 2018 Dec;51(12):1373-1377. doi: 10.1002/eat.22983.
PubMed 30584661Fletcher L, Trip H, Lawson R, Wilson N, Jordan J. Life is different now - impacts of eating disorders on Carers in New Zealand: a qualitative study. J Eat Disord. 2021 Jul 23;9(1):91. doi: 10.1186/s40337-021-00447-z.
PubMed 34301344Dalle Grave R, Eckhardt S, Calugi S, Le Grange D. A conceptual comparison of family-based treatment and enhanced cognitive behavior therapy in the treatment of adolescents with eating disorders. J Eat Disord. 2019 Dec 31;7:42. doi: 10.1186/s40337-019-0275-x. eCollection 2019.
PubMed 31893120Coelho JS, Suen J, Marshall S, Burns A, Lam PY, Geller J. Parental experiences with their child's eating disorder treatment journey. J Eat Disord. 2021 Jul 27;9(1):92. doi: 10.1186/s40337-021-00449-x.
PubMed 34315529Carpita B, Muti D, Cremone IM, Fagiolini A, Dell'Osso L. Eating disorders and autism spectrum: links and risks. CNS Spectr. 2022 Jun;27(3):272-280. doi: 10.1017/S1092852920002011. Epub 2020 Nov 9.
PubMed 33161925Bezance J, Holliday J. Mothers' experiences of home treatment for adolescents with anorexia nervosa: an interpretative phenomenological analysis. Eat Disord. 2014;22(5):386-404. doi: 10.1080/10640266.2014.925760. Epub 2014 Jul 14.
PubMed 25024015Agras WS. The consequences and costs of the eating disorders. Psychiatr Clin North Am. 2001 Jun;24(2):371-9. doi: 10.1016/s0193-953x(05)70232-x.
PubMed 11416936
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation for Parents of Adolescents With Anorexia Nervosa as a Supportive Treatment Approach
- ClinicalTrials.gov ID
- NCT07178977
- Acronym / sponsor ID
- PPO-ZD-MH
- Conditions
- Eating Disorders, Anorexia Nervosa
- Keywords
- eating disorders, Anorexia Nervosa, Parental Stress, Parental Coping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Psychoeducation for parents of adolescents with anorexia nervosa | Experimental | Behavioral: Psychoeducation groupParents 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. |
| Waitlist control group | Active comparator | Behavioral: Psychoeducation groupParents 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation groupA 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). | Behavioural | Experimental: Psychoeducation for parents of adolescents with anorexia nervosa, Waitlist control group |
Primary outcome
Change in Adolescent Body Mass Index (BMI)
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.
7 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 15478136Winn 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.
- Background: PubMed 22021124Macdonald 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.
- Background: PubMed 38727719Lee 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.
- Background: PubMed 34292530Konstantellou 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.
- Background: PubMed 16815322Hudson 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.
- Background: PubMed 18175232Honey 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.
- Background: PubMed 16879546Hillege 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.
- Background: PubMed 24891101Hibbs 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.
- Background: PubMed 30584661Fursland A, Erceg-Hurn DM, Byrne SM, McEvoy PM. A single session assessment and psychoeducational intervention for eating disorders: Impact on treatment waitlists and eating disorder symptoms. Int J Eat Disord. 2018 Dec;51(12):1373-1377. doi: 10.1002/eat.22983.
- Background: PubMed 34301344Fletcher L, Trip H, Lawson R, Wilson N, Jordan J. Life is different now - impacts of eating disorders on Carers in New Zealand: a qualitative study. J Eat Disord. 2021 Jul 23;9(1):91. doi: 10.1186/s40337-021-00447-z.
- Background: PubMed 31893120Dalle Grave R, Eckhardt S, Calugi S, Le Grange D. A conceptual comparison of family-based treatment and enhanced cognitive behavior therapy in the treatment of adolescents with eating disorders. J Eat Disord. 2019 Dec 31;7:42. doi: 10.1186/s40337-019-0275-x. eCollection 2019.
- Background: PubMed 34315529Coelho JS, Suen J, Marshall S, Burns A, Lam PY, Geller J. Parental experiences with their child's eating disorder treatment journey. J Eat Disord. 2021 Jul 27;9(1):92. doi: 10.1186/s40337-021-00449-x.
- Individual participant dataSharing planned: Yes. It is planned to publish it on the repository of University of Ljubljana. Personal data will not be provided, participants will be encrypted and unrecognizable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jana Kodrič, PhD study director
Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana
Marija Anderluh, PhD study chair
Unit of Child Psychiatry, University Children's hospital, University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation group in people with Eating Disorders and Anorexia Nervosa, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Žiga Damjanac (+38640251410, ziga.damjanac@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adolescent Body Mass Index (BMI) (time frame: Baseline (T1), Post-intervention (4 weeks, T2), Follow-up (3 months post-intervention, T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178977, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.