Preventive Health ServicesNCT03797898
Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care
A study testing Parent Coach in people with Preventive Health Services and Health Promotion, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preventive Health Services, Health Promotion
- What is being tested?
- Parent Coach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 937 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2019to 14 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit.
- Parent is English or Spanish proficient
- For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.
Who cannot join
- More than one child attending Well-Child Care
- Legal guardian of child is under 18 years of age
- Parents who are employed by one of the federally-qualified health centers (FQHCs)
- Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90095
Seattle Children's Research Institute
Seattle, Washington, 98121
About this study
Official title: Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.
The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
Read the detailed description
Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.
A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities.
To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.
To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics.
In preparation for the trial, investigators will use a Community Engagement \& Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.
- Conditions
- Preventive Health Services, Health Promotion
- Being tested
- Parent Coach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent CoachOther
The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Receives: Other: Parent Coach |
| Control | No intervention | usual care well child care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits
Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better
Measured: 12 months post enrollment
Healthcare Utilization: Emergency Department Utilization
any emergency department care visit for the index child in past 12 months (parent report)
Measured: 12 months post enrollment
Secondary outcomes (7)
Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit
time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.
Measured: Data not collected due to COVID Pandemic restrictions on in clinic observations.
Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits
Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items
Measured: 12 months post enrollment
Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.
Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.
Measured: 12 months post enrollment
Healthcare Utilization: Hospitalizations
any hospitalizations for index child in past 12 months by parent report
Measured: 12 months post enrollment
Healthcare Utilization: Well Child Care Visits Up to Date
up to date on well child care by clinic electronic medical record review at 12 months post enrollment
Measured: 12 months post enrollment
Experiences of Care: Helpfulness of Care Assessment by Parent Report
parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better
Measured: 12 months post enrollment
Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start5 Mar 2019
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preventive Health ServicesStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tumaini Coker, Seattle Children's Hospital
- Investigators
- Tumaini R Coker, MD/MBA, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797898
- Sponsor's protocol ID
- STUDY00000413
- Other IDs
- 5R01HD088586
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2018
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14.
PubMed 28232142Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.
PubMed 26908675Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
PubMed 23457149Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
PubMed 24936004Coker TR, Lowry SJ, Dwibedi E, Salaguinto T, Szilagyi PG, Fiscella K, Rangel SJ, Ortiz J, Weaver MR. Cost Analysis of the PARENT Trial of Community Health Workers in Early Childhood Preventive Care: A Secondary Analysis of a Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522732. doi: 10.1001/jamanetworkopen.2025.22732.
PubMed 40742591Coker TR, Liljenquist K, Lowry SJ, Fiscella K, Weaver MR, Ortiz J, LaFontaine R, Silva J, Salaguinto T, Johnson G, Friesema L, Porras-Javier L, Guerra LJS, Szilagyi PG. Community Health Workers in Early Childhood Well-Child Care for Medicaid-Insured Children: A Randomized Clinical Trial. JAMA. 2023 May 23;329(20):1757-1767. doi: 10.1001/jama.2023.7197.
PubMed 37120800Hurst R, Liljenquist K, Lowry SJ, Szilagyi PG, Fiscella KA, Weaver MR, Porras-Javier L, Ortiz J, Sotelo Guerra LJ, Coker TR. A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 25;10(11):e27054. doi: 10.2196/27054.
PubMed 34842563
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children
- ClinicalTrials.gov ID
- NCT03797898
- Acronym / sponsor ID
- STUDY00000413
- Conditions
- Preventive Health Services, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 937 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.
The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
Detailed description
Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.
A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities.
To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.
To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics.
In preparation for the trial, investigators will use a Community Engagement \& Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Parent CoachParents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). |
| Control | No intervention | –usual care well child care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit.
- Parent is English or Spanish proficient
- For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.
Key exclusion criteria (4 listed)
- More than one child attending Well-Child Care
- Legal guardian of child is under 18 years of age
- Parents who are employed by one of the federally-qualified health centers (FQHCs)
- Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months
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 |
|---|---|---|
| Parent CoachThe Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. | Other | Intervention |
Primary outcome
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits
Time frame: 12 months post enrollment
Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better
Healthcare Utilization: Emergency Department Utilization
Time frame: 12 months post enrollment
any emergency department care visit for the index child in past 12 months (parent report)
7 secondary outcomes
Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit
Time frame: Data not collected due to COVID Pandemic restrictions on in clinic observations.
Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits
Time frame: 12 months post enrollment
Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.
Time frame: 12 months post enrollment
Healthcare Utilization: Hospitalizations
Time frame: 12 months post enrollment
Healthcare Utilization: Well Child Care Visits Up to Date
Time frame: 12 months post enrollment
Experiences of Care: Helpfulness of Care Assessment by Parent Report
Time frame: 12 months post enrollment
Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
Time frame: 12 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28232142Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14.
- Background: PubMed 26908675Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.
- Background: PubMed 23457149Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
- Background: PubMed 24936004Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
- Derived from this study: PubMed 40742591Coker TR, Lowry SJ, Dwibedi E, Salaguinto T, Szilagyi PG, Fiscella K, Rangel SJ, Ortiz J, Weaver MR. Cost Analysis of the PARENT Trial of Community Health Workers in Early Childhood Preventive Care: A Secondary Analysis of a Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522732. doi: 10.1001/jamanetworkopen.2025.22732.
- Derived from this study: PubMed 37120800Coker TR, Liljenquist K, Lowry SJ, Fiscella K, Weaver MR, Ortiz J, LaFontaine R, Silva J, Salaguinto T, Johnson G, Friesema L, Porras-Javier L, Guerra LJS, Szilagyi PG. Community Health Workers in Early Childhood Well-Child Care for Medicaid-Insured Children: A Randomized Clinical Trial. JAMA. 2023 May 23;329(20):1757-1767. doi: 10.1001/jama.2023.7197.
- Derived from this study: PubMed 34842563Hurst R, Liljenquist K, Lowry SJ, Szilagyi PG, Fiscella KA, Weaver MR, Porras-Javier L, Ortiz J, Sotelo Guerra LJ, Coker TR. A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 25;10(11):e27054. doi: 10.2196/27054.
- 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. This study is not recruiting at the moment.
Tumaini R Coker, MD/MBA principal investigator
Seattle Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Coach in people with Preventive Health Services and Health Promotion, run by Seattle Children's Hospital at 2 sites 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 3 inclusion and 4 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits (time frame: 12 months post 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?
On the ClinicalTrials.gov record for NCT03797898, which also lists 7 linked publications.
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 26 Jun 2023.