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Expressive Writing for COVID-19 Resilience for Parents

Primary Purpose

Parents During COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive writing
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parents During COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

In order to have up to 40 evaluable subjects, we plan to consent up to 45 individuals. Potential subjects will be considered eligible if they are parents or primary caregivers of children aged 0-18 who have been home with them during the COVID-19 experience. Other eligibility criteria include:

  • Able to speak, read, write, and understand English
  • Cognitively able to provide consent
  • Ability to participate in a 4-week intervention delivered via Zoom and email

Sites / Locations

  • Duke Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Expressive writing

Arm Description

The 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email. The progression of writing exercises flows as follows: Week 1: Writing to expressive difficult emotions Week 2: Writing to cultivate compassion & forgiveness Week 3: Writing to nurture positive emotions Week 4: Writing to invite insight, perspective, & growth

Outcomes

Primary Outcome Measures

Resilience
Connor-Davidson Resilience Scale (CD-RISC)

Secondary Outcome Measures

Perceived stress
Perceived Stress Scale-10 (PSS-10)
Depression symptoms
Center for Epidemiologic Studies Depression Scale Revised (CESDR)
Parental stress
Internal, non-validated questionnaire re. experience of parental stress

Full Information

First Posted
October 12, 2020
Last Updated
November 16, 2021
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04589117
Brief Title
Expressive Writing for COVID-19 Resilience for Parents
Official Title
Expressive Writing for COVID-19 Resilience for Parents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
August 2, 2020 (Actual)
Study Completion Date
August 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the impact of a 4-week, virtually-delivered expressive writing intervention on resilience in a cohort of parents and caregivers currently navigating the COVID-19 pandemic during spring & summer of 2020.
Detailed Description
In 2016, the research team piloted a 6-week intervention on expressive writing for resilience in a population of trauma survivors. Participants self-identified as having had a recent trauma or significant life upheaval, such as a divorce, major illness, job loss, or the death of a loved one. At 6 weeks, the investigators found that participants experienced significantly improved levels of resilience and lower levels of stress, rumination, and depression. These results added to a growing body of research indicating the potential for expressive writing to be a powerful healing modality for both psychological and physical well-being. The current COVID-19 pandemic presents the potential for trauma or significant life upheaval for nearly all members of the community and the world at large. Parents of children who are at home face unique challenges during this time. Social distancing guidelines, shelter in place protocols, school and business closures, travel restrictions, high levels of job loss, loss of childcare, and the looming threat of illness have disrupted daily routines, family life, and significantly altered life plans for many. Parents and caregivers who have unexpectedly lost childcare, are having to adjust to home schooling arrangements, and/or are having to end to heightened emotional needs in their children may experience this time as particularly difficult. Resilience is the capacity for individuals to adapt and recover in the face of trauma, adversity, or significant sources of stress. The current collective reality magnifies the need for accessible, low-cost, effective interventions to help people cultivate resilience and other dimensions of psychological well-being. In this study, the investigators seek to further the work the research team began in 2016 with a 4-week, virtually-delivered expressive writing intervention designed to support parents in cultivating personal resilience and emotional wellness during the COVID-19 pandemic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parents During COVID-19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expressive writing
Arm Type
Experimental
Arm Description
The 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email. The progression of writing exercises flows as follows: Week 1: Writing to expressive difficult emotions Week 2: Writing to cultivate compassion & forgiveness Week 3: Writing to nurture positive emotions Week 4: Writing to invite insight, perspective, & growth
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
The 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email. The progression of writing exercises flows as follows: Week 1: Writing to expressive difficult emotions Week 2: Writing to cultivate compassion & forgiveness Week 3: Writing to nurture positive emotions Week 4: Writing to invite insight, perspective, & growth
Primary Outcome Measure Information:
Title
Resilience
Description
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perceived stress
Description
Perceived Stress Scale-10 (PSS-10)
Time Frame
3 months
Title
Depression symptoms
Description
Center for Epidemiologic Studies Depression Scale Revised (CESDR)
Time Frame
3 months
Title
Parental stress
Description
Internal, non-validated questionnaire re. experience of parental stress
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In order to have up to 40 evaluable subjects, we plan to consent up to 45 individuals. Potential subjects will be considered eligible if they are parents or primary caregivers of children aged 0-18 who have been home with them during the COVID-19 experience. Other eligibility criteria include: Able to speak, read, write, and understand English Cognitively able to provide consent Ability to participate in a 4-week intervention delivered via Zoom and email
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Glass, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Expressive Writing for COVID-19 Resilience for Parents

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