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

NCT ID: NCT06989593

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2026-05-31

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

Conditions

DSD; Hypospadias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Narrative Medicine Journaling Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Therapeutic Writing; Reflective Journaling; Guided Narrative Intervention; Narrative Medicine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Catalyst Pilot Grant

UNKNOWN

Sponsor Role: collaborator

Sarah Schlegel

OTHER

Sponsor Role: lead

Responsible Party

Sarah Schlegel

Attending Physician in Endocrinology, Instructor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Schlegel, MD, MS

Role: CONTACT

Journaling@childrens.harvard.edu

617-355-3523

Other Identifiers

89676

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-P00051291

Identifier Type: -

Identifier Source: org_study_id