CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 312 enrolled
Drug / intervention
Usual care +7 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03569449
NCT03569449N/ACompleted

Optimizing a Paraprofessional, Family Partner Navigation Model for Children

Boston Medical Center·interventional·Posted Jun 26, 2018·Updated Nov 26, 2025

In Brief

A clinical study evaluating Usual care, Clinic-based visits, and 6 other interventions for Health Behavior. Completed, enrolled 312 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealth Behavior
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartJun 24, 2019
Primary CompletionJun 21, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.0 years ago

Interventions

Usual carebehavioral

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

Clinic-based visitsbehavioral

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

Standard pediatric surveillancebehavioral

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

Structured, schedule-based visitsbehavioral

Family Partners will utilize a predetermined schedule of contacts with families

Enhanced pediatric surveillancebehavioral

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

Technology enhanced care coordinationbehavioral

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).

:Individually-tailored visitsbehavioral

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

Clinic-based visits and community visitsbehavioral

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.