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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Clinica Oscar A Romero

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Telephone-based developmental screening and care coordination
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
6 months
Number of Participants That Receive Services
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
Time Frame: 6 months
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.
6 months
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
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)
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Robert Wood Johnson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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