Psychoeducation for Parents of Adolescents With Anorexia Nervosa as a Supportive Treatment Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Adolescent Body Mass Index (BMI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The nature of the intervention (Psychoeducation and waitlist groups) makes it impossible to mask interventions assigned.
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental: Psychoeducation for parents of adolescents with anorexia nervosa
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.
干预措施: Psychoeducation group (Behavioral)
Waitlist control group
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.
干预措施: Psychoeducation group (Behavioral)
结局指标
主要结局
Change in Adolescent Body Mass Index (BMI)
时间窗: 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.
次要结局
- 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).)
- Parent-Reported Adolescent Anxiety and Depression - Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P)(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 Perceived Social Support - Multidimensional Scale of Perceived Social Support (MSPSS).(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).)