Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
2 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
October 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedOctober 23, 2025
May 1, 2025
7 months
May 22, 2025
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in GAD-7 Anxiety Scores
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.
Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation
Secondary Outcomes (4)
Qualitative Assessment of Anxiety Related to Child's Diagnosis
Measured at one follow-up interview, approximately 6 weeks after intervention initiation
Changes in Parental Coping Strategies
Measured at one follow-up interview, approximately 6 weeks after intervention initiation
Interest in Group-Based Writing Interventions
Approximately 6 weeks after intervention initiation
Feasibility and Acceptability of Journaling Intervention
Approximately 6 weeks after intervention initiation
Study Arms (1)
Narrative Medicine Journaling Intervention
EXPERIMENTALAll participants in this single-arm pilot study will complete baseline GAD-7 anxiety assessments, participate in a guided journaling program, complete follow-up GAD-7 assessments, and take part in a qualitative interview. Parents of children with urogenital conditions (differences of sex development and hypospadias) will receive the narrative medicine intervention over a period of several weeks, with pre- and post-intervention anxiety measurements and interview assessments.
Interventions
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. Following completion of the journaling intervention, participants will complete a follow-up GAD-7 assessment and take part in a 30-45 minute qualitative interview to further assess perceived changes in anxiety, stress, and coping strategies, and to gather feedback on potential group-based writing programs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sarah Schlegellead
- Harvard Catalyst Pilot Grantcollaborator
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician in Endocrinology, Instructor of Pediatrics
Study Record Dates
First Submitted
May 22, 2025
First Posted
May 25, 2025
Study Start
October 10, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
October 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because this pilot study primarily collects sensitive qualitative data through personal narratives and interviews concerning parents' experiences with their children's urogenital conditions. The small sample size and detailed personal accounts could potentially lead to participant identification even if de-identified, raising significant confidentiality and privacy concerns. Additionally, during the informed consent process, participants will not have been specifically asked for permission to share their raw data beyond the research team. The study will instead focus on sharing aggregate findings and thematic analyses while protecting participants' confidentiality. If future researchers are interested in the data, specific requests may be considered by the IRB on a case-by-case basis with appropriate data use agreements.