DSD, Hypospadias
Conditions
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, Male Urogenital Diseases, Congenital Abnormalities, Gonadal Disorders, Endocrine System Diseases
Brief 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). 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
Interventions
BEHAVIORALNarrative 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.
Sponsors
Sarah Schlegel
Harvard Catalyst Pilot Grant
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GAD-7 Anxiety Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Assessment of Anxiety Related to Child's Diagnosis | 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. |
| Changes in Parental Coping Strategies | 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. |
| Interest in Group-Based Writing Interventions | 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 |
| Feasibility and Acceptability of Journaling Intervention | 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 |
Countries
United States
Contacts
CONTACTAlex Wheelock
CONTACTSarah Schlegel, MD, MS
Outcome results
None listed