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

Not Applicable

Not yet recruiting

• Conditions: DSD; Hypospadias

• Registration Number: NCT06989593
• Lead Sponsor: Sarah Schlegel

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-07
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (differences of sex development and/or hypospadias)
• Able to read and understand English
• Child receives care at Boston Children's Hospital
• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in GAD-7 Anxiety Scores	Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation	Change from baseline in General Anxiety Disorder-7 (GAD-7) scores. The GAD-7 is a validated 7-item self-report questionnaire used to assess anxiety symptom severity. Scores range from 0-21, with higher scores indicating greater anxiety symptoms.

Secondary Outcome Measures

Name	Time	Method
Qualitative Assessment of Anxiety Related to Child's Diagnosis	Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Semi-structured interviews to assess participants' self-reported changes in anxiety specifically related to their child's urogenital condition following the narrative medicine intervention, including perceived changes in stress, worry frequency, and emotional distress related to the diagnosis.
Changes in Parental Coping Strategies	Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Qualitative assessment through semi-structured interviews of participants' self-reported changes in coping mechanisms, including reduction in feelings of self-blame, increased sense of control, and development of new strategies for managing uncertainty following the journaling intervention.
Interest in Group-Based Writing Interventions	Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Assessment of parents' interest in and preferences for potential group-based writing interventions, including identification of perceived benefits, potential barriers to participation, and suggestions for implementation approaches.
Feasibility and Acceptability of Journaling Intervention	Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Assessment of participation rates, completion of journal entries, and participant feedback on the structure, content, and delivery of the journaling intervention to inform future program development.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States