Social StressNCT04179825
Parents' and Clinicians' Perspectives of the Quick Parenting Assessment (QPA)
An observational study of Social Stress and Parenting, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
A quality improvement (QI) study that integrates an adverse childhood experiences (ACEs) instrument, including the Quick Parenting Assessment (QPA), into pediatric primary care visit. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Stress, Parenting
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 4 Mar 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents of young children presenting with their child for a well visit.
Who may be able to join
- Parents of 1-10 year old children presenting to a pediatric clinic for a well child visit.
- Exclusion Criteria: Parents who do not speak English, Spanish, or Arabic.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Integration of the Quick Parenting Assessment (QPA) Into Pediatrics: Parents and Clinicians' Perspectives
A quality improvement (QI) study that integrates an adverse childhood experiences (ACEs) instrument, including the Quick Parenting Assessment (QPA), into pediatric primary care visit.
Read the detailed description
Adverse childhood experiences (ACEs) are social determinants of health. ACEs include exposure to unhealthy parenting and family dysfunction. It is known that people who are exposed to adverse childhood experiences (ACEs) are at increased risk of over 40 health problems; some of these include heart disease, lung disease, obesity, smoking, alcoholism, illicit drug use, depression, suicide, and violence. The American Academy of Pediatrics recommends that primary care providers screen for and address ACEs/social determinants of health as part of the routine primary care visit.
Efforts are needed to develop and test algorithms that assess for ACEs in pediatric primary care and intervene as indicated.
The investigators have tested an ACEs screening instrument that includes the Quick Parenting Assessment with hundreds of parents of 2-10 year old children in the pediatric primary care clinic at Vanderbilt without incident (please see IRB# 161987).
The next step is a quality improvement (QI) study that integrates an ACEs screening algorithm into pediatric primary care visit.
In this study, the investigators integrate the Quick Parenting Assessment into the pediatric primary care visit at the 15 month, 30 month, 5 year, and 8 year visit. Key measures include parents' and health care providers' perspectives on the new service.
- Conditions
- Social Stress, Parenting
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent feedback
Parents provide feedback regarding whether the new ACEs screening tool works for them using a questionnaire. The questionnaire included questions about whether the ACEs assessment worked for the parent and whether it was culturally sensitive.
Measured: One day. The outcome will be assessed on same day as enrollment.
Health care provider feedback.
Health care providers provide feedback regarding whether the new ACEs screening tool works for them using a questionnaire. The questionnaire will include questions such as time spent reviewing the screening tool and whether the screening tool resulted in recommendations that would have otherwise not been made.
Measured: One day. This outcome will be assessed on same day as the parent's enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start18 Dec 2018
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social StressStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Scholer, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179825
- Sponsor's protocol ID
- 180956
- Status last verified
- Feb 2024
- First submitted
- 7 Nov 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of the Quick Parenting Assessment (QPA) Into Pediatrics: Parents and Clinicians' Perspectives
- ClinicalTrials.gov ID
- NCT04179825
- Acronym / sponsor ID
- 180956
- Conditions
- Social Stress, Parenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 27 Nov 2019 (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.
A quality improvement (QI) study that integrates an adverse childhood experiences (ACEs) instrument, including the Quick Parenting Assessment (QPA), into pediatric primary care visit.
Detailed description
Adverse childhood experiences (ACEs) are social determinants of health. ACEs include exposure to unhealthy parenting and family dysfunction. It is known that people who are exposed to adverse childhood experiences (ACEs) are at increased risk of over 40 health problems; some of these include heart disease, lung disease, obesity, smoking, alcoholism, illicit drug use, depression, suicide, and violence. The American Academy of Pediatrics recommends that primary care providers screen for and address ACEs/social determinants of health as part of the routine primary care visit.
Efforts are needed to develop and test algorithms that assess for ACEs in pediatric primary care and intervene as indicated.
The investigators have tested an ACEs screening instrument that includes the Quick Parenting Assessment with hundreds of parents of 2-10 year old children in the pediatric primary care clinic at Vanderbilt without incident (please see IRB# 161987).
The next step is a quality improvement (QI) study that integrates an ACEs screening algorithm into pediatric primary care visit.
In this study, the investigators integrate the Quick Parenting Assessment into the pediatric primary care visit at the 15 month, 30 month, 5 year, and 8 year visit. Key measures include parents' and health care providers' perspectives on the new service.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of young children presenting with their child for a well visit.
Key inclusion criteria (2 listed)
- Parents of 1-10 year old children presenting to a pediatric clinic for a well child visit.
- Exclusion Criteria: Parents who do not speak English, Spanish, or Arabic.
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.
Primary outcome
Parent feedback
Time frame: One day. The outcome will be assessed on same day as enrollment.
Parents provide feedback regarding whether the new ACEs screening tool works for them using a questionnaire. The questionnaire included questions about whether the ACEs assessment worked for the parent and whether it was culturally sensitive.
Health care provider feedback.
Time frame: One day. This outcome will be assessed on same day as the parent's enrollment.
Health care providers provide feedback regarding whether the new ACEs screening tool works for them using a questionnaire. The questionnaire will include questions such as time spent reviewing the screening tool and whether the screening tool resulted in recommendations that would have otherwise not been made.
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 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Stress and Parenting, 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?
The sponsor lists 2 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 22 Feb 2024. 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?
Parent feedback (time frame: One day. The outcome will be assessed on same day as enrollment.). The study lists 2 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 22 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.