Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

NCT ID: NCT02495025

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-02-28

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.

Conditions

Child Development; Developmental Disabilities; Ambulatory Care; Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone-based developmental screening and care coordination

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telephone-based developmental screening and care coordination

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 42 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Paul Chung

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Chung, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Universilty of California, Los Angeles

Locations

Clinica Oscar A Romero

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30894408 (View on PubMed)

Other Identifiers

15-000509

Identifier Type: -

Identifier Source: org_study_id