An interventional study of Narrative Medicine Journaling Intervention in DSD and Hypospadias, sponsored by Sarah Schlegel. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Sarah Schlegel · Not applicable, Interventional, and Supportive care
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:
Participants will:
123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 97 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →This is the only study on the registry with Sarah Schlegel as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Therapeutic Writing, Reflective Journaling, Guided Narrative Intervention, Narrative Medicine
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.
Time frame: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Approximately 6 weeks after intervention initiation
Plan to share: 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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