NCT03569449

Family Partner Navigation for Children

Optimizing a Paraprofessional, Family Partner Navigation Model for Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

The goal of this study is to determine the optimal delivery of a Family Navigation (FN) model that increases engagement in services to address children's behavioral health. While there is strong evidence that navigation decreases barriers to care for low income and minority families, little is known about which specific components contribute to its efficacy. The investigators propose to use MOST, a pioneering, engineering-inspired framework, to assess the performance of individual intervention components and their interactions. Delivery of FN will be systematically varied across four components, each of which is represented by a separate factor in the 2x2x2x2 factorial study design. Specifically, each family will be randomly assigned to one of two conditions within each of four factors or delivery strategies, defining sixteen separate experimental conditions. Strategies include: (A) technology-assisted delivery of care coordination using an innovative, web-based platform called Act.MD (compared to usual care); (B) clinic based FN + community-based (compared to clinic-based only); (C) enhanced symptom tracking using more frequent behavioral symptom tracking (compared to standard pediatric surveillance); and (d) individually-tailored visits (compared to a predetermined schedule of contacts). All children will be followed through the electronic health record (EHR) for 12 months, for outcomes in services access and symptom tracking. The main effects will be estimated of the four experimental factors and their interactions on the study's primary outcome - family engagement in services to address their child's behavioral health. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden. Children will be enrolled if they have a positive behavioral health screen OR parent concern. A "watchful waiting" group for families of children with more mild symptoms and/or who do not choose to access child behavioral services at the time of the index visit with the Family Partner (FP) will be included. These families will be followed and child symptoms tracked at 3, 6, 9 and 12 months. If the watchful waiting children have an increase in symptom severity, and/or the family later desires services, they will have the opportunity to receive FN services and be randomized to a study condition.

Conditions

• Health Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-24
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2018-06-26
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States