Clinical trial NCT06989593: Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
Official title: Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: DSD
Hypospadias
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
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Catalyst Pilot Grant
First posted: 2025-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (differences of sex development and/or hypospadias)
* Able to read and understand English
* Child receives care at Boston Children's Hospital
* 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

Primary outcomes:
measure: Change in GAD-7 Anxiety Scores
timeFrame: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation
Secondary outcomes:
measure: Qualitative Assessment of Anxiety Related to Child's Diagnosis
timeFrame: Measured at one follow-up interview, approximately 6 weeks after intervention initiation
measure: Changes in Parental Coping Strategies
timeFrame: Measured at one follow-up interview, approximately 6 weeks after intervention initiation
measure: Interest in Group-Based Writing Interventions
timeFrame: Approximately 6 weeks after intervention initiation
measure: Feasibility and Acceptability of Journaling Intervention
timeFrame: Approximately 6 weeks after intervention initiation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: