Clinical trial NCT03569449: Family Partner Navigation for Children
Official title: Optimizing a Paraprofessional, Family Partner Navigation Model for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Family navigation
Family partners
Multiphase optimization strategy (MOST)
Pediatric Symptom Checklist-17
Survey of Wellbeing of Young children (SWYC)
Family Resource Scale
Federally qualified community health center
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-06-26
Enrollment: 667
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

All children who are 3-12 years old:

* who screen positive on the Survey of Wellbeing of Young Children (SWYC) (3-5 years) OR
* who screen positive on the Pediatric Symptom Checklist-17 (PSC-17) (6-12 years) OR
* whose parents indicate a behavioral health concern during any pediatric visit

Exclusion Criteria:

* Children who are already actively engaged in behavioral health specialty care services, defined as having had a behavioral health visit in the last 30 days, who do not require new additional services
* Children with active psychosis
* Children with safety concerns requiring emergency mental health services.

Primary outcomes:
measure: Times to services
timeFrame: 90 days from randomization
measure: Access to services [Yes/No]
timeFrame: 90 days from randomization
measure: Change in the Survey of Well-being of Young Children (SWYC)
timeFrame: baseline, 12 months
measure: Change in Pediatric Symptom Checklist-17 (PSC-17)
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Satisfaction with Hospital Care Questionnaire (SHCQ)
timeFrame: 6 months
measure: Interpersonal Relationship with Navigator (PSN-I)
timeFrame: 6 months
measure: Change in Family Resource Scale (FRS)
timeFrame: baseline, 12 months
measure: Change in Patient Health Questionnaire-2 [PHQ-2}
timeFrame: baseline, 12 months
measure: Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Dorchester
country: United States
facility: DotHouse Health
state: Massachusetts
Study officials:
affiliation: Boston Medical Center and Boston University SPH
name: Emily Feinberg, ScD, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broder-Fingert S, Kuhn J, Sheldrick RC, Chu A, Fortuna L, Jordan M, Rubin D, Feinberg E. Using the Multiphase Optimization Strategy (MOST) framework to test intervention delivery strategies: a study protocol. Trials. 2019 Dec 16;20(1):728. doi: 10.1186/s13063-019-3853-y.