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Completed

NCT Number: NCT02495025

Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

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.

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Key information

Age range

12 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Oscar A Romero

Los Angeles, California, 90057, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-based developmental screening and care coordination

Behavioral

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

Developing and Testing a New Model for Telephone-based Early Childhood Developmental Screening and Care Coordination in Vulnerable Populations

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2015
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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