- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495025
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening
September 24, 2019 updated by: Paul Chung, University of California, Los Angeles
Developing and Testing a New Model for Telephone-based Early Childhood Developmental Screening and Care Coordination in Vulnerable Populations
The purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic.
Investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Although the American Academy of Pediatrics (AAP) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the AAP guidelines.
One intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns.
2-1-1 Los Angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design.
Investigators partnered with the Clinica Oscar A Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income Latino families.
Investigators hope to enroll up to 300 families in the study.
Eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic.
As investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups.
Intervention group families will be transferred to 211 Los Angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90057
- Clinica Oscar A Romero
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- child receives well-child care at the clinic
- child is not already receiving intervention services for a developmental disability
- parent speaks Spanish or English well enough to be interviewed
Exclusion Criteria:
- child is younger than 12 months or older than 42 months at time of enrollment
- child is already receiving intervention services for a developmental disability
- parent is unable to speak Spanish or English well enough to be interviewed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telephone-based screening
Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone.
Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT).
If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services.
A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.
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No Intervention: Usual care
Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination.
Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Screened With a Validated Tool
Time Frame: 6 months
|
We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP.
Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version.
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6 months
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Number of Participants That Receive Services
Time Frame: 6 months
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Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
Time Frame: 6 months
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Based on medical record review, parent report, and 211 data, we measured whether any referrals were made for children with developmental or behavioral concerns, for evaluation or services.
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6 months
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Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
Time Frame: Baseline and 6 months
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Based on parent interviews we will assess family experiences with primary care including receipt of recommended well-child care, using recommended anticipatory guidance and family-centered care items from the Promoting Healthy Development Survey (PHDS)
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Baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul J Chung, MD, MS, Universilty of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
February 28, 2017
Study Registration Dates
First Submitted
July 8, 2015
First Submitted That Met QC Criteria
July 10, 2015
First Posted (Estimate)
July 13, 2015
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-000509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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