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| ID | Type | Description | Link |
|---|---|---|---|
| 89676 | Other Grant/Funding Number | Harvard Catalyst Pediatric Clinical Research Pilot Grant |
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| Name | Class |
|---|---|
| Harvard Catalyst Pilot Grant | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at one follow-up interview, approximately 6 weeks after intervention initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Wheelock | Contact | 617-919-7031 | Journaling@childrens.harvard.edu | |
| Sarah Schlegel, MD, MS | Contact | 617-355-3523 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| D012734 | Disorders of Sex Development |
| D001008 | Anxiety Disorders |
| D013315 | Stress, Psychological |
| D010358 | Patient Participation |
| D000092862 | Psychological Well-Being |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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 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 | 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 | Approximately 6 weeks after intervention initiation |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D010549 | Personal Satisfaction |