Recruiting

Journaling Intervention

Sponsor:

Sarah Schlegel

Code:

NCT06989593

Conditions

DSD

Hypospadias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Narrative Medicine Journaling Intervention

Study Details

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

Conditions

DSD

Hypospadias

Study ID

NCT06989593

Start date

Oct 10, 2025

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Narrative Medicine Journaling Intervention

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.

Interventions

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.

Primary outcome measure

  • Change in GAD-7 Anxiety Scores [ Time Frame: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation ]

Central Contacts and Locations

Central contacts

Alex Wheelock

617-919-7031Journaling@childrens.harvard.edu

Sarah Schlegel, MD, MS

617-355-3523

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Sarah Schlegel, MD, MS

More Information

Sponsor

Sarah Schlegel

Last update posted

May 18, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sarah Schlegel on 2026-05-18.