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NCT Number: NCT06989593

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

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Key information

Conditions

DSD Anxiety Disorders Behavior Behavioral Symptoms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Gonadal Disorders Health Behavior Hypospadias Male Urogenital Diseases Mental Disorders Patient Acceptance of Health Care Patient Participation Penile Diseases Personal Satisfaction Psychological Well-Being Stress, Psychological Treatment Adherence and Compliance Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Sarah Schlegel, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Medicine Journaling Intervention

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.

Other names: Therapeutic Writing, Reflective Journaling, Guided Narrative Intervention, Narrative Medicine

Primary outcomes

  1. Change in GAD-7 Anxiety Scores

    Time frame: 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 outcomes

  1. Qualitative Assessment of Anxiety Related to Child's Diagnosis

    Time frame: 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.

  2. Changes in Parental Coping Strategies

    Time frame: 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.

  3. Interest in Group-Based Writing Interventions

    Time frame: 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. Measured at one follow-up interview, approximately 6 weeks after intervention initiation

  4. Feasibility and Acceptability of Journaling Intervention

    Time frame: 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. Measured at one follow-up interview, approximately 6 weeks after intervention initiation

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Wheelock

CONTACT

[email protected]

617-919-7031

Sarah Schlegel, MD, MS

CONTACT

617-355-3523

Sponsors and collaborators

Lead sponsor

Sarah Schlegel

Other

Collaborators

  • Harvard Catalyst Pilot Grant

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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