Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

Not Applicable

Completed

• Conditions: Child Development; Screening; Developmental Disabilities; Ambulatory Care
• Interventions: Behavioral: Telephone-based developmental screening and care coordination

• Registration Number: NCT02495025
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Primary Completion: 2016-12-31
• Study Completion: 2017-02-28
• Results First Submitted: 2018-10-09
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Results First Posted: 2019-10-14
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone-based screening	Telephone-based developmental screening and care coordination	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Screened With a Validated Tool	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.
Number of Participants That Receive Services	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 Outcome Measures

Name	Time	Method
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	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)
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)	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.

Trial Locations

Locations (1)

Clinica Oscar A Romero; 🇺🇸 Los Angeles, California, United States