Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarah Schlegel
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Narrative Medicine Journaling Intervention
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Narrative Medicine Journaling InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 initiationSecondary outcomes
1
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 initiation2
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 initiation3
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 initiation4
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 initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sarah Schlegel
Lead sponsor
Boston Children's Hospital
Sponsor institution
Harvard Catalyst Pilot Grant
Collaborator
Source ClinicalTrials.gov