NCT03569449

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

June 15, 2018

Results QC Date

September 30, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Family navigationFamily partnersMultiphase optimization strategy (MOST)Pediatric Symptom Checklist-17Survey of Wellbeing of Young children (SWYC)Family Resource ScaleFederally qualified community health center

Outcome Measures

Primary Outcomes (2)

  • Goal Completion

    Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.

    6 months

  • Time to Goal Completion

    Time to goal completion obtained from the electronic health record including Family Partner's template documentation.

    18 months

Secondary Outcomes (7)

  • Change in the Survey of Well-being of Young Children (SWYC)

    baseline, 6 months

  • Change in Pediatric Symptom Checklist-17 (PSC-17)

    baseline, 6 months

  • Satisfaction With Hospital Care Questionnaire (SHCQ)

    6 months

  • Interpersonal Relationship With Navigator (PSN-I)

    6 months

  • Change in Family Resource Scale (FRS)

    baseline, 6 months

  • +2 more secondary outcomes

Study Arms (16)

Group 1- Goat

EXPERIMENTAL

Clinic-based visit, usual care, standard pediatric surveillance, and structured visits

Behavioral: Usual careBehavioral: Clinic-based visitsBehavioral: Standard pediatric surveillanceBehavioral: Structured, schedule-based visits

Group 2- Cow

EXPERIMENTAL

Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits

Behavioral: Usual careBehavioral: Clinic-based visitsBehavioral: Structured, schedule-based visitsBehavioral: Enhanced pediatric surveillance

Group 3- Horse

EXPERIMENTAL

Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits

Behavioral: Clinic-based visitsBehavioral: Standard pediatric surveillanceBehavioral: Structured, schedule-based visitsBehavioral: Technology enhanced care coordination

Group 4- Pig

EXPERIMENTAL

Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits

Behavioral: Clinic-based visitsBehavioral: Structured, schedule-based visitsBehavioral: Enhanced pediatric surveillanceBehavioral: Technology enhanced care coordination

Group 5- Sheep

EXPERIMENTAL

Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits

Behavioral: Usual careBehavioral: Clinic-based visitsBehavioral: Standard pediatric surveillanceBehavioral: :Individually-tailored visits

Group 6- Llama

EXPERIMENTAL

Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits

Behavioral: Usual careBehavioral: Clinic-based visitsBehavioral: Enhanced pediatric surveillanceBehavioral: :Individually-tailored visits

Group 7- Cat

EXPERIMENTAL

Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits

Behavioral: Clinic-based visitsBehavioral: Standard pediatric surveillanceBehavioral: Technology enhanced care coordinationBehavioral: :Individually-tailored visits

Group 8- Dog

EXPERIMENTAL

Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits

Behavioral: Clinic-based visitsBehavioral: Enhanced pediatric surveillanceBehavioral: Technology enhanced care coordinationBehavioral: :Individually-tailored visits

Group 9- Donkey

EXPERIMENTAL

Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits

Behavioral: Usual careBehavioral: Standard pediatric surveillanceBehavioral: Structured, schedule-based visitsBehavioral: Clinic-based visits and community visits

Group 10- Bear

EXPERIMENTAL

Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits

Behavioral: Usual careBehavioral: Structured, schedule-based visitsBehavioral: Enhanced pediatric surveillanceBehavioral: Clinic-based visits and community visits

Group 11- Tiger

EXPERIMENTAL

Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits

Behavioral: Standard pediatric surveillanceBehavioral: Structured, schedule-based visitsBehavioral: Technology enhanced care coordinationBehavioral: Clinic-based visits and community visits

Group 12- Lion

EXPERIMENTAL

Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits

Behavioral: Structured, schedule-based visitsBehavioral: Enhanced pediatric surveillanceBehavioral: Technology enhanced care coordinationBehavioral: Clinic-based visits and community visits

Group 13- Monkey

EXPERIMENTAL

Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits

Behavioral: Usual careBehavioral: Standard pediatric surveillanceBehavioral: :Individually-tailored visitsBehavioral: Clinic-based visits and community visits

Group 14- Zebra

EXPERIMENTAL

Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits

Behavioral: Usual careBehavioral: Enhanced pediatric surveillanceBehavioral: :Individually-tailored visitsBehavioral: Clinic-based visits and community visits

Group 15- Elephant

EXPERIMENTAL

Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits

Behavioral: Standard pediatric surveillanceBehavioral: Technology enhanced care coordinationBehavioral: :Individually-tailored visitsBehavioral: Clinic-based visits and community visits

Group 16- Giraffe

EXPERIMENTAL

Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits

Behavioral: Enhanced pediatric surveillanceBehavioral: Technology enhanced care coordinationBehavioral: :Individually-tailored visitsBehavioral: Clinic-based visits and community visits

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.

Group 1- GoatGroup 10- BearGroup 13- MonkeyGroup 14- ZebraGroup 2- CowGroup 5- SheepGroup 6- LlamaGroup 9- Donkey

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

Group 1- GoatGroup 2- CowGroup 3- HorseGroup 4- PigGroup 5- SheepGroup 6- LlamaGroup 7- CatGroup 8- Dog

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

Group 1- GoatGroup 11- TigerGroup 13- MonkeyGroup 15- ElephantGroup 3- HorseGroup 5- SheepGroup 7- CatGroup 9- Donkey

Family Partners will utilize a predetermined schedule of contacts with families

Group 1- GoatGroup 10- BearGroup 11- TigerGroup 12- LionGroup 2- CowGroup 3- HorseGroup 4- PigGroup 9- Donkey

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

Group 10- BearGroup 12- LionGroup 14- ZebraGroup 16- GiraffeGroup 2- CowGroup 4- PigGroup 6- LlamaGroup 8- Dog

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).

Group 11- TigerGroup 12- LionGroup 15- ElephantGroup 16- GiraffeGroup 3- HorseGroup 4- PigGroup 7- CatGroup 8- Dog

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

Group 13- MonkeyGroup 14- ZebraGroup 15- ElephantGroup 16- GiraffeGroup 5- SheepGroup 6- LlamaGroup 7- CatGroup 8- Dog

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.

Group 10- BearGroup 11- TigerGroup 12- LionGroup 13- MonkeyGroup 14- ZebraGroup 15- ElephantGroup 16- GiraffeGroup 9- Donkey

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DotHouse Health

Dorchester, Massachusetts, 02122, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Emily Feinberg, ScD, CPNP
Organization
Boston Medical Center, Boston University School of Public Health

Study Officials

  • Emily Feinberg, ScD, CPNP

    Boston Medical Center and Boston University SPH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

June 24, 2019

Primary Completion

June 21, 2024

Study Completion

June 21, 2024

Last Updated

November 26, 2025

Results First Posted

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations