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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Child Development; Health Services Research

Treatments: Behavioral: Telephone-based early childhood developmental care coordination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04118452

7R01HD092406-02 (U.S. NIH Grant/Contract)

19-001556

Details and patient eligibility

About

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.

Full 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.

Enrollment: 565 patients

Sex: All

Ages: 11 to 42 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

565 participants in 2 patient groups

Intervention + Usual Care + Developmental Screening Results

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-based early childhood developmental care coordination

Usual Care + Developmental Screening Results

No Intervention group

Description:

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