Family Partner Navigation for Children

NCT03569449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-11-26

Study results available
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Summary

Family Navigation (FN), an evidence-based care management strategy which is a promising intervention to help low income and minority families access timely mental health services. Despite significant evidence supporting the effectiveness of FN, concerns exist about the ability to disseminate FN to a broad population due to inefficiency and cost. The proposed study employs an innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The investigators will conduct a randomized experiment to assess the individual components of FN and identify which components and component levels have greatest effect on access to, and engagement in, diagnostic and treatment services for children with mental health disorders. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden

Conditions

  • Health Behavior

Interventions

BEHAVIORAL

Usual care

Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.

BEHAVIORAL

Clinic-based visits

Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits

BEHAVIORAL

Standard pediatric surveillance

Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.

BEHAVIORAL

Structured, schedule-based visits

Family Partners will utilize a predetermined schedule of contacts with families

BEHAVIORAL

Enhanced pediatric surveillance

In Massachusetts, behavioral screening is mandated at every pediatric visit, which for children in the target population (ages 3-12 years) is annually. With "enhanced monitoring," Family Partners will screen children using validated instruments quarterly and communicate results to the child's care team

BEHAVIORAL

Technology enhanced care coordination

Behavioral: technology enhanced care coordination FPs will also have access to Act.MD, a cloud-based care coordination and communication tool that offers the potential to improve communication with families, schools, and the primary care site through administration of online questions, videoconferencing, and common portals that can be used by parents and multiple providers (e.g., FP, pediatrician, teacher).

BEHAVIORAL

:Individually-tailored visits

Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts

BEHAVIORAL

Clinic-based visits and community visits

In clinic-based visits the Family Partner is restricted to working at the primary care clinic and communication is restricted to telephone, text, and clinic visits. However in conditions with clinic based and community visits, the Family Partners will be available to meet families in their home and community (as well as the clinic), and accompany families to community-based meetings at school or childcare.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Emily Feinberg, ScD, CPNP · Boston Medical Center and Boston University SPH

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2024-06-21
Completion
2024-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569449 on ClinicalTrials.gov