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Completed

NCT Number: NCT04118452

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

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.

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Key information

Conditions

Child Development Health Services Research

Age range

11 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. Child Developmental Outcomes

    Time frame: 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 outcomes

  1. Number of Children Who Have Received Referrals and Number of Children Who Have Received Services

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Official study title

A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

Acronym: AMP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2019
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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