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Purpose

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

Condition

Eligibility

Eligible Ages
Between 3 Years and 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1- Goat 		Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
  • 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
Experimental
Group 2- Cow 		Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
  • 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: 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
Experimental
Group 3- Horse 		Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
  • 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: 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).
Experimental
Group 4- Pig 		Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
  • 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: 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).
Experimental
Group 5- Sheep 		Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
  • 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: :Individually-tailored visits
    Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Experimental
Group 6- Llama 		Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
  • 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: 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: :Individually-tailored visits
    Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Experimental
Group 7- Cat 		Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
  • 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: 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
Experimental
Group 8- Dog 		Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
  • 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: 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
Experimental
Group 9- Donkey 		Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
  • 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: 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: 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.
Experimental
Group 10- Bear 		Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
  • 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: 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: 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.
Experimental
Group 11- Tiger 		Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured 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: 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: 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.
Experimental
Group 12- Lion 		Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
  • 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: 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.
Experimental
Group 13- Monkey 		Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
  • 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: Standard pediatric surveillance
    Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
  • 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.
Experimental
Group 14- Zebra 		Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
  • 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: 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: :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.
Experimental
Group 15- Elephant 		Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
  • Behavioral: Standard pediatric surveillance
    Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
  • 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.
Experimental
Group 16- Giraffe 		Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
  • 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.

More Details

Status
Completed
Sponsor
Boston Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.