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

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

Study Overview

• Status: Recruiting
• Conditions: Hypospadias; DSD
• Intervention / Treatment: Behavioral: Narrative Medicine Journaling Intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Wheelock; Phone Number: 617-919-7031; Email: Journaling@childrens.harvard.edu
• Study Contact Backup: Name: Sarah Schlegel, MD, MS; Phone Number: 617-355-3523

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Principal Investigator: Sarah Schlegel, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Narrative Medicine Journaling Intervention; All 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.

Behavioral: 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. 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.; Other Names: Therapeutic Writing; Reflective Journaling; Guided Narrative Intervention; Narrative Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Assessment of Anxiety Related to Child's Diagnosis	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.	Measured at one follow-up interview, approximately 6 weeks after intervention initiation
Changes in Parental Coping Strategies	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.	Measured at one follow-up interview, approximately 6 weeks after intervention initiation
Interest in Group-Based Writing Interventions	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. Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Approximately 6 weeks after intervention initiation
Feasibility and Acceptability of Journaling Intervention	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. Measured at one follow-up interview, approximately 6 weeks after intervention initiation	Approximately 6 weeks after intervention initiation

Collaborators and Investigators

• Sponsor: Sarah Schlegel
• Collaborators: Harvard Catalyst Pilot Grant

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Anxiety; Congenital Abnormalities; Stress, Psychological; Parents; Patient Participation; Social Support; Writing; Endocrine System Diseases; Hypospadias; Urogenital Abnormalities; Qualitative Research; Female Urogenital Diseases; Male Urogenital Diseases; Interpersonal Relations; Genital Diseases, Male; Gonadal Disorders; Psychological Adaptation; Narrative Therapy; Genital Diseases; Parent-Child Relations; Disorders of Sex Development; Urogenital Diseases; Penile Diseases
• Additional Relevant MeSH Terms: Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Behavioral Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Treatment Adherence and Compliance; Health Behavior; Personal Satisfaction; Patient Acceptance of Health Care; Urogenital Diseases; Genital Diseases; Congenital Abnormalities; Anxiety Disorders; Stress, Psychological; Endocrine System Diseases; Male Urogenital Diseases; Hypospadias; Female Urogenital Diseases; Disorders of Sex Development; Genital Diseases, Male; Urogenital Abnormalities; Penile Diseases; Gonadal Disorders; Psychological Well-Being; Patient Participation
• Other Study ID Numbers: IRB-P00051291; 89676 (Other Grant/Funding Number: Harvard Catalyst Pediatric Clinical Research Pilot Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No