Clinical trial NCT02495025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Developmental Disabilities
Ambulatory Care
Screening
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2015-07-13
Enrollment: 152
Sex: ALL
Minimum age (years): 12
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Screened With a Validated Tool
timeFrame: 6 months
measure: Number of Participants That Receive Services
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
timeFrame: 6 months
measure: Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinica Oscar A Romero
state: California
Study officials:
affiliation: Universilty of California, Los Angeles
name: Paul J Chung, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.