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

May 14, 2026 updated by: Sarah Schlegel

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measured at one follow-up interview, approximately 6 weeks after intervention initiation
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.
Measured at one follow-up interview, approximately 6 weeks after intervention initiation
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
Approximately 6 weeks after intervention initiation
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
Approximately 6 weeks after intervention initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sarah Schlegel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Catalyst Pilot Grant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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