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Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

Primary Purpose

Child Development, Developmental Disabilities, Ambulatory Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based developmental screening and care coordination
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Child Development

Eligibility Criteria

12 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Oscar A Romero

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone-based screening

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Screened With a Validated Tool
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.
Number of Participants That Receive Services
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.

Secondary Outcome Measures

Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
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.
Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
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)

Full Information

First Posted
July 8, 2015
Last Updated
September 24, 2019
Sponsor
University of California, Los Angeles
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02495025
Brief Title
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening
Official Title
Developing and Testing a New Model for Telephone-based Early Childhood Developmental Screening and Care Coordination in Vulnerable Populations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development, Developmental Disabilities, Ambulatory Care, Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized individually at the time of enrollment, to receive either telephone-based developmental screening and care coordination, through 2-1-1 Los Angeles, in addition to usual care, or usual care alone. Primary outcomes were measured at 6 months after enrollment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone-based screening
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based developmental screening and care coordination
Primary Outcome Measure Information:
Title
Number of Participants Screened With a Validated Tool
Description
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.
Time Frame
6 months
Title
Number of Participants That Receive Services
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
Description
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.
Time Frame
6 months
Title
Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
Description
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)
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Chung, MD, MS
Organizational Affiliation
Universilty of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Oscar A Romero
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30894408
Citation
Nelson BB, Thompson LR, Herrera P, Biely C, Arriola Zarate D, Aceves I, Estrada I, Chan V, Orantes C, Chung PJ. Telephone-Based Developmental Screening and Care Coordination Through 2-1-1: A Randomized Trial. Pediatrics. 2019 Apr;143(4):e20181064. doi: 10.1542/peds.2018-1064.
Results Reference
derived

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Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

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