DSDNCT06989593
Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
A study testing Narrative Medicine Journaling Intervention in people with DSD and Hypospadias, run by Sarah Schlegel at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DSD, Hypospadias
- What is being tested?
- Narrative Medicine Journaling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Schlegel, MD, MS contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sarah Schlegel, MD, MS
About this study
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:
Read more
- 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
- Being tested
- Narrative Medicine Journaling Intervention
- Keywords
- Disorders of Sex Development, Hypospadias, Anxiety, Stress, Psychological, Parents, Psychological Adaptation, Writing, Narrative Therapy, Qualitative Research, Patient Participation, Social Support, Mental Health, Interpersonal Relations, Parent-Child Relations, Urogenital Abnormalities, Female Urogenital Diseases, Urogenital Diseases, Penile Diseases, Genital Diseases, Male, Genital Diseases
- Medical subject headings
- Hypospadias, Disorders of Sex Development, Anxiety Disorders, Stress, Psychological, Patient Participation, Psychological Well-Being, Urogenital Abnormalities, Female Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Medicine Journaling InterventionBehavioural
Also called Therapeutic Writing, Reflective Journaling, Guided Narrative Intervention, Narrative Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Medicine Journaling Intervention | Experimental | 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. Receives: Behavioral: Narrative Medicine Journaling Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation
Secondary outcomes (4)
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: 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: 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
Measured: 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
Measured: Approximately 6 weeks after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start10 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Schlegel
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Catalyst Pilot Grant
- Responsible party
- Sponsor-investigator, Sarah Schlegel, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989593
- Sponsor's protocol ID
- IRB-P00051291
- Other IDs
- 89676
- Status last verified
- May 2026
- First submitted
- 22 May 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
- ClinicalTrials.gov ID
- NCT06989593
- Acronym / sponsor ID
- IRB-P00051291
- Conditions
- DSD, Hypospadias
- Keywords
- Disorders of Sex Development, Hypospadias, Anxiety, Stress, Psychological, Parents, Psychological Adaptation, Writing, Narrative Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sarah SchlegelUniversity, hospital or other
- Collaborators
- Harvard Catalyst Pilot Grant
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrative Medicine Journaling Intervention | Experimental | Behavioral: Narrative Medicine Journaling InterventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Medicine Journaling InterventionAlso: Therapeutic Writing, Reflective Journaling, Guided Narrative Intervention, Narrative MedicineParticipants 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. | Behavioural | Narrative Medicine Journaling Intervention |
Primary outcome
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.
4 secondary outcomes
Qualitative Assessment of Anxiety Related to Child's Diagnosis
Time frame: 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
Interest in Group-Based Writing Interventions
Time frame: Approximately 6 weeks after intervention initiation
Feasibility and Acceptability of Journaling Intervention
Time frame: Approximately 6 weeks after intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Schlegel, MD, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Medicine Journaling Intervention in people with DSD and Hypospadias, run by Sarah Schlegel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Wheelock (617-919-7031, Journaling@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GAD-7 Anxiety Scores (time frame: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.