Parents During COVID-19NCT04589117
Expressive Writing for COVID-19 Resilience for Parents
A study testing Expressive writing in people with Parents During COVID-19, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents During COVID-19
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 2 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Parents During COVID-19
- Being tested
- Expressive writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing | Experimental | 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 Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
Connor-Davidson Resilience Scale (CD-RISC)
Measured: 3 months
Secondary outcomes (3)
Perceived stress
Perceived Stress Scale-10 (PSS-10)
Measured: 3 months
Depression symptoms
Center for Epidemiologic Studies Depression Scale Revised (CESDR)
Measured: 3 months
Parental stress
Internal, non-validated questionnaire re. experience of parental stress
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start27 May 2020
- Primary completion2 Aug 2020
- Study completion2 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents During COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Glass, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589117
- Sponsor's protocol ID
- Pro00105586
- Status last verified
- Nov 2021
- First submitted
- 12 Oct 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing for COVID-19 Resilience for Parents
- ClinicalTrials.gov ID
- NCT04589117
- Acronym / sponsor ID
- Pro00105586
- Conditions
- Parents During COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 2 Aug 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expressive writing | Experimental | Behavioral: Expressive writingThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingThe 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 | Behavioural | Expressive writing |
Primary outcome
Resilience
Time frame: 3 months
Connor-Davidson Resilience Scale (CD-RISC)
3 secondary outcomes
Perceived stress
Time frame: 3 months
Depression symptoms
Time frame: 3 months
Parental stress
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Glass, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Parents During COVID-19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.