Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

NCT04118452 | Completed Results

• 2 other identifiers: 19-0015567R01HD092406-02
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 4

Brief Summary

The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.

Conditions

Child Development; Health Services Research

Keywords

early childhood development; developmental screening; care coordination

Outcome Measures

Primary Outcomes (2)

• Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment

  The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, and 2) the percentage of children who receive services.

  6 months after enrollment

• Child Developmental Outcomes

  The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's "developmental age" as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve.

  Baseline and 24 months after enrollment

Secondary Outcomes (1)

• Number of Children Who Have Received Referrals and Number of Children Who Have Received Services

  6 months after enrollment

Study Arms (2)

Intervention + Usual Care + Developmental Screening Results

EXPERIMENTAL

Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention.

Behavioral: Telephone-based early childhood developmental care coordination

Usual Care + Developmental Screening Results

NO INTERVENTION

This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.

Interventions

Telephone-based early childhood developmental care coordination BEHAVIORAL

The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR (Electronic Medical Record) by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.

Intervention + Usual Care + Developmental Screening Results

Eligibility Criteria

• Age: 11 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care)
• A patient with an upcoming one- to three-year old well child appointment scheduled
• Child aged 11-42 months

You may not qualify if:

• Parent who does not speak English or Spanish
• Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services.
• Child has a sibling already enrolled in the study.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Kaiser Permanente School of Medicine: collaborator
• Virginia Commonwealth University: collaborator
• Information and Referral Federation of Los Angeles County (211 LA County): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

South Central Family Health Center

Los Angeles, California, 90011, United States

Location

Via Care

Los Angeles, California, 90022, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

ChapCare

Pasadena, California, 91103, 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 BACKGROUND

Results Point of Contact

• Title: Dr. Paul Chung, Professor and Principal Investigator
• Organization: University of California, Los Angeles & Kaiser Permanente School of Medicine

paul.j.chung@kp.org

626-710-0389

Study Officials

• Paul J Chung, MD MS

  Kaiser Permanente School of Medicine

  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: Adjunct Professor of Pediatrics and Health Policy & Management

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 8, 2019
• Study Start: January 17, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared within 2 years of study completion.
• Access Criteria: Proposals should be directed to paul.j.chung@kp.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be provided when requests are approved.

Locations

US (4)