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

Not Applicable

Completed

• Conditions: Health Services Research; Child Development
• Interventions: Behavioral: Telephone-based early childhood developmental care coordination

• Registration Number: NCT04118452
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).

Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.

Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Study Start: 2020-01-17
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Results First Submitted: 2024-11-21
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Results First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention + Usual Care + Developmental Screening Results	Telephone-based early childhood developmental care coordination	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.

Primary Outcome Measures

Name	Time	Method
Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment	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.
Child Developmental Outcomes	Baseline and 24 months after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Number of Children Who Have Received Referrals and Number of Children Who Have Received Services	6 months after enrollment	The secondary outcome will be assessed by the number of 1) children with referrals made, and 2) children with services received; the investigators will primarily consider referrals to high-level intervention services for developmental and behavioral problems, but will also track referrals to development-related preventive and support services.; Intervention services include Part C early intervention (EI), Part B early childhood special education (ECSE), physical therapy (PT), occupational therapy (OT), and speech therapy.; Early care and education (ECE) includes child care, preschool, Head Start, and Early Head Start.

Trial Locations

Locations (4)

South Central Family Health Center; 🇺🇸 Los Angeles, California, United States

Via Care; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

ChapCare; 🇺🇸 Pasadena, California, United States