Development, ChildTIDESNCT04326179
Targeting Infant Development With Early Screening
An observational study of Development, Child, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Development, Child
- How many people
- 7,720 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 6 Aug 2021
- 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 Up to 3 years
- All sexes
- Child
Study population: Duke Children's Primary Care Roxboro Road
Who may be able to join
- Seen for a well child check at Duke Children's Primary Care Roxboro Road.
- Age 0 to 4 at day of visit
- Seen for well check at Duke Children's Primary Care Roxboro Road
- Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services
- Age 0 to 4 at day of visit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.
Read the detailed description
Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.
- Conditions
- Development, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Age 0 to 4 at day of visit | This study is based on chart reviews of data collected as part of clinical care. Data collected as part of this study will not directly inform the care of participating patients and families. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening results
We will use data extracts from the electronic health system to examine rates of meeting positive/negative thresholds on screening tools used as part of clinical care.
Measured: 18 months
Secondary outcomes (4)
Screening compliance
We will use data extracts from the electronic health system to examine screening compliance rate
Measured: 18 months
Rate of attending scheduled appointments (show rate)
We will use data extracts from the electronic health system to examine rate of families attending their scheduled appointments and no-show rate
Measured: 18 months
Healthcare utilization
Data extracts from Epic and/or from DEDUCE will be used to evaluate healthcare utilization. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.
Measured: 18 months
Referral rates
Data extracts from Epic and/or from DEDUCE will be used to evaluate rates of referrals to other services. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start4 Nov 2019
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, ChildStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra Best, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326179
- Sponsor's protocol ID
- Pro00103604
- Acronym
- TIDES
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2020
- Last updated
- 24 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Infant Development With Early Screening
- ClinicalTrials.gov ID
- NCT04326179
- Acronym / sponsor ID
- TIDES / Pro00103604
- Conditions
- Development, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,720 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 30 Mar 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 assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.
Detailed description
Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age 0 to 4 at day of visit | – | –This study is based on chart reviews of data collected as part of clinical care. Data collected as part of this study will not directly inform the care of participating patients and families. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Duke Children's Primary Care Roxboro Road
Key inclusion criteria (5 listed)
- Seen for a well child check at Duke Children's Primary Care Roxboro Road.
- Age 0 to 4 at day of visit
- Seen for well check at Duke Children's Primary Care Roxboro Road
- Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services
- Age 0 to 4 at day of visit
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
Screening results
Time frame: 18 months
We will use data extracts from the electronic health system to examine rates of meeting positive/negative thresholds on screening tools used as part of clinical care.
4 secondary outcomes
Screening compliance
Time frame: 18 months
Rate of attending scheduled appointments (show rate)
Time frame: 18 months
Healthcare utilization
Time frame: 18 months
Referral rates
Time frame: 18 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 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Development, Child
Recruiting
SIT and Deep Pressure Therapy Effects on Motor Coordination in Children With ASD
Autism Spectrum Disorder
Not yet recruiting
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Autism Spectrum Disorder, TMS
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
Active, not recruitingObservational study
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Healthy Children, Children With Neurodevelopmental Disorders
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.
Debra Best, MD 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?
An observational study of Development, Child, 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 5 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 Apr 2023. 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?
Screening results (time frame: 18 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 Apr 2023.