Critical IllnessPICUJournalNCT06117345
Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal
A study testing PICU Journal in people with Critical Illness, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- PICU Journal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Parent/Caregiver Inclusion Criteria:
- The participant is a primary caregiver of a pediatric patient (ages 1 month to 21 years) admitted to the pediatric intensive care unit (PICU) at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV)
- The participant's child meets the criteria for Levels 1 or 2 of the Early Mobility Protocol at MCJCHV
- The participant's child has been hospitalized in the PICU for between 24 and 72 hours at the time of informed consent.
- The participant has not had prior experience with their child(ren) being admitted to the PICU.
- The participant is proficient in reading and writing the English language.
Parent/Caregiver Exclusion Criteria:
- The participant is unwilling to provide consent.
- The participant is unable to read and write in the English language.
Child Inclusion Criteria:
- The child participant is between the ages of 8 to 17 years.
- The participant is proficient in reading and writing the English language.
Child Exclusion Criteria:
- The participant is unwilling to provide assent.
- The participant is unable to read and write in the English language.
Staff Inclusion Criteria:
- The participant(s) interact with patients in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt.
- The participant is proficient in reading and writing the English language.
Staff Exclusion Criteria
- The participant is unable to read and write in the English language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A Pilot Study of a PICU Journal Intervention
Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU.
Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019).
Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.
Read the detailed description
Eligible participants will be identified by their primary Certified Child Life Specialist (CCLS) using the daily PICU census and electronic medical record. All eligible participants will first be approached by the child life specialist on their care team to provide brief information about the study and refer to the key study personnel (KSP) if the parent/caregiver is interested in learning more. If they are potentially interested in participating, a member of the KSP (comprised of a doctoral level CCLS, psychology graduate students, PICU physician, and research nurses) will approach the parent/caregiver at bedside and give information and obtain consent. When approaching for consent, the KSP will first obtain approval to approach from the patient's bedside nurse to ensure it is a feasible and appropriate time to do so. All parents/caregivers who indicate interest will be approached to participate to ensure a diverse and broad sample, until a total of 75 parents/caregivers have completed participation in the study. No randomization will be used.
Once consent has been given by the parent/caregiver (using an electronic consent form housed in REDCap), they will complete a short demographic survey in REDCap. The family will then be given the PICU Journal along with supplies and instructions on how to access additional pages and the photo printer. The PICU Journal was developed by conducting extensive research on perceived stressors in the PICU, post-intensive care syndrome in pediatrics and their families, and the use of dairies in the intensive care unit setting, along with consultation from Certified Child Life Specialists, and with input from family advisors. Families will be able to take the original journal home with them.
Data will be collected at three-time points: time one (T1) between 24 and 72 hours of the child's admission, time two (T2), peri-discharge, and time three (T3) three months post-discharge.
Timepoint 1 (T1) Between 24 - 72 hours after admission:
Parent Participation Consent Form Illness Severity (Chart Review) Child Demographics (Chart Review) Parent Demographics Survey Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit (APSS: PICU) Caregiving Health Engagement Scale (CHE-s)
Timepoint 2 (T2) Peri-discharge Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit (A-PSS: PICU) Caregiving Health Engagement Scale (CHE-s) Hospital Anxiety and Depression Scale (HADS) Journal Use \& Satisfaction Survey
Timepoint 3 (T3) 3 months post-discharge:
Hospital Anxiety and Depression Scale (HADS) Impact of Events Scale-Revised (IES-R) At Home Journal Use \& Satisfaction Survey Child Participation Assent Form (Child Report) Child Revised Impact of Events Scale (CRIES-8) (Child Report)
*Semi-Structured Interview (Parents)
At the conclusion of the study :
Provider Satisfaction Survey
- Conditions
- Critical Illness
- Being tested
- PICU Journal
- Keywords
- Critical care, Intensive care, Pediatrics, Family-Centered Care, Family Engagement, PICU Liberation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICU JournalBehavioural
Also called PICU diary
A hard-copy, customizable educational/therapeutic/expressive journal for parents/caregivers to seek information and document their child's PICU experiences and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Parents/Caregivers | Experimental | Parents/caregivers of children hospitalized in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt who will participate in the PICU journal intervention Receives: Behavioral: PICU Journal |
| Patients | No intervention | Pediatric patients ages 8 to 18 years whose parents/caregivers participated in the PICU journal intervention |
| PICU providers and staff | No intervention | PICU providers and staff who observed or participated in the PICU journal intervention during its use with parents/caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent/Caregiver reported stress level
Score on the Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit; 7 Likert type items scored from 1 to 5, with 1 being "not stressful" and 5 being "extremely stressful." Composite scores can range from 0 (not experienced) to 35 (extremely stressful).
Measured: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)
Parent/Caregiver care engagement level
Score on the Caregiving Health Engagement Scale; 7 items with four answer choices scored from 1 to 4. Composite scores can range from 7 (minimal engagement) to 28 (high engagement).
Measured: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)
Parent/Caregiver reported depression and anxiety symptoms
Score on the Hospital Anxiety and Depression Scale; two subscales (anxiety and depression) with 7 items each. Items have 4 answer choices scored from 1 to 4, with higher numbers indicating higher alignment with anxiety or depression. Cut scores are used to determine clinical significance; a total score of less than 7 on a subscale indicates a non-case, 8-10 on a subscale indicates mild, 11-14 indicates moderate, and 15 to 21 is considered severe.
Measured: within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)
Parent/caregiver reported impact of events
Score on Impact of Events Scale-Revised; 20 Likert-type items scored from 0 (not experienced) to 4 (extremely distressed). Total composite scores can range from 0 (not experienced) to 80 (extremely distressed).
Measured: at 3 months post-discharge (T3)
Parent/Caregiver use of and satisfaction with PICU journal
Responses to a descriptive survey created by research team to assess frequency/type of PICU journal use and completion, as well as parent/caregiver perceptions of feasibility and utility
Measured: within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)
Child reported impact of events
Score on the Child Revised Impact of Events Scale; 8 items with four answer choices scored from 0 (not at all) to 3 (often). Total composite scores can range from 0 (not at all distressed) t to 24 (extremely distressed).
Measured: at 3 months post-discharge (T3)
Parent/caregiver Experiences Interview
Responses to semi-structured interview about PICU journal perceptions and experiences (in-person, by phone, or by teleconference)
Measured: at 3 months post-discharge (T3)
PICU Staff perceptions of PICU journal intervention
Responses to a descriptive survey created by research team to collect perceptions about and level of engagement with PICU journal intervention
Measured: Through study completion, an expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start15 May 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Jessika Boles, Vanderbilt University Medical Center
- Investigators
- Kristina Betters, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117345
- Sponsor's protocol ID
- 231386
- Acronym
- PICUJournal
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A Pilot Study of a PICU Journal Intervention
- ClinicalTrials.gov ID
- NCT06117345
- Acronym / sponsor ID
- PICUJournal / 231386
- Conditions
- Critical Illness
- Keywords
- Critical care, Intensive care, Pediatrics, Family-Centered Care, Family Engagement, PICU Liberation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 7 Nov 2023 (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.
Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU.
Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019).
Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.
Detailed description
Eligible participants will be identified by their primary Certified Child Life Specialist (CCLS) using the daily PICU census and electronic medical record. All eligible participants will first be approached by the child life specialist on their care team to provide brief information about the study and refer to the key study personnel (KSP) if the parent/caregiver is interested in learning more. If they are potentially interested in participating, a member of the KSP (comprised of a doctoral level CCLS, psychology graduate students, PICU physician, and research nurses) will approach the parent/caregiver at bedside and give information and obtain consent. When approaching for consent, the KSP will first obtain approval to approach from the patient's bedside nurse to ensure it is a feasible and appropriate time to do so. All parents/caregivers who indicate interest will be approached to participate to ensure a diverse and broad sample, until a total of 75 parents/caregivers have completed participation in the study. No randomization will be used.
Once consent has been given by the parent/caregiver (using an electronic consent form housed in REDCap), they will complete a short demographic survey in REDCap. The family will then be given the PICU Journal along with supplies and instructions on how to access additional pages and the photo printer. The PICU Journal was developed by conducting extensive research on perceived stressors in the PICU, post-intensive care syndrome in pediatrics and their families, and the use of dairies in the intensive care unit setting, along with consultation from Certified Child Life Specialists, and with input from family advisors. Families will be able to take the original journal home with them.
Data will be collected at three-time points: time one (T1) between 24 and 72 hours of the child's admission, time two (T2), peri-discharge, and time three (T3) three months post-discharge.
Timepoint 1 (T1) Between 24 - 72 hours after admission:
Parent Participation Consent Form Illness Severity (Chart Review) Child Demographics (Chart Review) Parent Demographics Survey Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit (APSS: PICU) Caregiving Health Engagement Scale (CHE-s)
Timepoint 2 (T2) Peri-discharge Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit (A-PSS: PICU) Caregiving Health Engagement Scale (CHE-s) Hospital Anxiety and Depression Scale (HADS) Journal Use \& Satisfaction Survey
Timepoint 3 (T3) 3 months post-discharge:
Hospital Anxiety and Depression Scale (HADS) Impact of Events Scale-Revised (IES-R) At Home Journal Use \& Satisfaction Survey Child Participation Assent Form (Child Report) Child Revised Impact of Events Scale (CRIES-8) (Child Report)
*Semi-Structured Interview (Parents)
At the conclusion of the study :
Provider Satisfaction Survey
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parents/Caregivers | Experimental | Behavioral: PICU JournalParents/caregivers of children hospitalized in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt who will participate in the PICU journal intervention |
| Patients | No intervention | –Pediatric patients ages 8 to 18 years whose parents/caregivers participated in the PICU journal intervention |
| PICU providers and staff | No intervention | –PICU providers and staff who observed or participated in the PICU journal intervention during its use with parents/caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PICU JournalAlso: PICU diaryA hard-copy, customizable educational/therapeutic/expressive journal for parents/caregivers to seek information and document their child's PICU experiences and outcomes. | Behavioural | Parents/Caregivers |
Primary outcome
Parent/Caregiver reported stress level
Time frame: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)
Score on the Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit; 7 Likert type items scored from 1 to 5, with 1 being "not stressful" and 5 being "extremely stressful." Composite scores can range from 0 (not experienced) to 35 (extremely stressful).
Parent/Caregiver care engagement level
Time frame: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)
Score on the Caregiving Health Engagement Scale; 7 items with four answer choices scored from 1 to 4. Composite scores can range from 7 (minimal engagement) to 28 (high engagement).
Parent/Caregiver reported depression and anxiety symptoms
Time frame: within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)
Score on the Hospital Anxiety and Depression Scale; two subscales (anxiety and depression) with 7 items each. Items have 4 answer choices scored from 1 to 4, with higher numbers indicating higher alignment with anxiety or depression. Cut scores are used to determine clinical significance; a total score of less than 7 on a subscale indicates a non-case, 8-10 on a subscale indicates mild, 11-14 indicates moderate, and 15 to 21 is considered severe.
Parent/caregiver reported impact of events
Time frame: at 3 months post-discharge (T3)
Score on Impact of Events Scale-Revised; 20 Likert-type items scored from 0 (not experienced) to 4 (extremely distressed). Total composite scores can range from 0 (not experienced) to 80 (extremely distressed).
Parent/Caregiver use of and satisfaction with PICU journal
Time frame: within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)
Responses to a descriptive survey created by research team to assess frequency/type of PICU journal use and completion, as well as parent/caregiver perceptions of feasibility and utility
Child reported impact of events
Time frame: at 3 months post-discharge (T3)
Score on the Child Revised Impact of Events Scale; 8 items with four answer choices scored from 0 (not at all) to 3 (often). Total composite scores can range from 0 (not at all distressed) t to 24 (extremely distressed).
Parent/caregiver Experiences Interview
Time frame: at 3 months post-discharge (T3)
Responses to semi-structured interview about PICU journal perceptions and experiences (in-person, by phone, or by teleconference)
PICU Staff perceptions of PICU journal intervention
Time frame: Through study completion, an expected average of 2 years
Responses to a descriptive survey created by research team to collect perceptions about and level of engagement with PICU journal intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Kristina Betters, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICU Journal in people with Critical Illness, run by Vanderbilt University Medical Center 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?
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: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Parent/Caregiver reported stress level (time frame: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)). The study lists 8 primary outcomes in all. 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 9 Jun 2026.