Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

NCT02495025 | Completed Results

• 1 other identifier: 15-000509
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development; Developmental Disabilities; Ambulatory Care; Screening

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (2)

• Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)

  6 months

• Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always

  Baseline and 6 months

Study Arms (2)

Telephone-based screening

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Telephone-based developmental screening and care coordination BEHAVIORAL

Telephone-based screening

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Clinica Oscar A Romero

Los Angeles, California, 90057, United States

Location

Related Publications (1)

• 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.

  PMID: 30894408 DERIVED

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Sample of 152 children enrolled is relatively small, comes from single clinic system and was fairly homogeneous in terms of race and ethnicity, primary language, and other socio-demographic variables.

Results Point of Contact

• Title: Principal Research Manager, Health Services Research Program
• Organization: University of California Los Angeles

lindseythompson@mednet.ucla.edu

310-825-8624

Study Officials

• Paul J Chung, MD, MS

  Universilty of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: February 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: February 28, 2017
• Last Updated: October 14, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-09

Locations

US (1)