Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495025
• Other study ID #: 15-000509
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: September 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 28, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 42 Months

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Care
• Child Development
• Developmental Disabilities
• Screening

Intervention

Behavioral:
• Telephone-based developmental screening and care coordination

Locations

Country	Name	City	State
United States	Clinica Oscar A Romero	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)	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.	6 months
Secondary	Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always	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)	Baseline and 6 months