Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions

Обзор

The goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias). The main questions it aims to answer are: * Does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions? * What are parents' perspectives on group-based writing interventions for future support programs? Participants will: * Complete a short anxiety questionnaire (the General Anxiety Disorder-7 scale) at the beginning of the study * Receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition * Complete 5 journal entries over several weeks, writing about their experiences and feelings * Complete the same anxiety questionnaire again after finishing the journal entries * Participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs

Вмешательства

• Поведенческое Narrative Medicine Journaling Intervention
  Participants will complete the GAD-7 anxiety assessment at baseline. They will then receive a physical journal containing 5 structured, therapeutic writing prompts designed to help process emotions related to their child's diagnosis. Prompts focus on processing experiences with diagnosis, addressing uncertainty, coping with stigma, and developing resilience. Parents will be instructed to complete the 5 journal entries, spending 15-20 minutes on each writing session at least once per week. Follow

Первичные конечные точки

• Change in GAD-7 Anxiety Scores [Срок оценки: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation]

Вторичные конечные точки (4)

• Qualitative Assessment of Anxiety Related to Child's Diagnosis [Срок оценки: Measured at one follow-up interview, approximately 6 weeks after intervention initiation]
• Changes in Parental Coping Strategies [Срок оценки: Measured at one follow-up interview, approximately 6 weeks after intervention initiation]
• Interest in Group-Based Writing Interventions [Срок оценки: Approximately 6 weeks after intervention initiation]
• Feasibility and Acceptability of Journaling Intervention [Срок оценки: Approximately 6 weeks after intervention initiation]

Критерии участия

Критерии включения

• Parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (such as differences of sex development or hypospadias)
• Able to read and understand English
• Willing to complete a guided journaling intervention (through writing or dictation) over a period of approximately 5 weeks
• Willing to participate in a 45 minute follow-up interview
• Able to provide informed consent

Критерии исключения

• Parent/guardian with severe psychiatric disorder that would interfere with participation as determined by referring physician
• Parent/guardian unable to complete either written journaling activities or dictation
• Inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Boston Children's Hospital — Boston

Идентификаторы

NCT: NCT06989593 · IRB-P00051291 · 89676

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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