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Family Partner Navigation for Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569449
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston Medical Center

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

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Usual care Behavioral: Clinic-based visits Behavioral: Standard pediatric surveillance Behavioral: Structured, schedule-based visits Behavioral: Enhanced pediatric surveillance Behavioral: Technology enhanced care coordination Behavioral: :Individually-tailored visits Behavioral: Clinic-based visits and community visits Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Optimizing a Paraprofessional, Family Partner Navigation Model for Children
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Times to services [ Time Frame: 90 days from randomization ]
    Time from randomization to 1st behavioral health service encounter obtained from the electronic health record including Family Partner's template documentation

  2. Access to services [Yes/No] [ Time Frame: 90 days from randomization ]
    1st encounter with behavioral health services within 90 days of randomization obtained from the electronic health record including Family Partner's template documentation

  3. Change in the Survey of Well-being of Young Children (SWYC) [ Time Frame: baseline, 12 months ]
    The SWYC screens for cognitive, motor, language, and social-emotional development among children up to 5½ years of age. Behavioral symptoms will be tracked using the SWYC's Preschool Pediatric Symptom Checklist (PPSC), is an 18-item questionnaire with possible scores for each item of:"0" for each "Not at All" response, "1" for each "Somewhat" response, and "2" for each "Very Much" response. The total score is summed, can range from 0 to 36, and A PPSC total score of 9 or greater indicates that a child is "at risk" and needs further evaluation

  4. Change in Pediatric Symptom Checklist-17 (PSC-17) [ Time Frame: baseline, 12 months ]
    Scores from the Pediatric Symptom Checklist-17 (PSC-17) will be used to assess child symptoms. The PSC-17 is a 17-item psychosocial screen designed to recognize cognitive, emotional, and behavioral problems. A value of 0 is assigned to "Never", 1 to "Sometimes," and 2 to "Often". The total score is calculated by adding together the score for each of the 17 items, with a potential range of total scores of 0 to 34.. A PSC-17 score of 15 or higher suggests the presence of significant behavioral or emotional problems.. PSC-17 is embedded in the Epic (electronic health record) as a self-scoring form.


Secondary Outcome Measures :
  1. Retention in services [ Time Frame: 90 days from 1st visit behavioral health services encounter ]
    ≥4 visits or resolution of service need obtained from the electronic health record, including Family Partner's template documentation, for families receiving psychotherapeutic and/or psychopharmacological services.

  2. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 6 months ]
    The CSQ-8 has 8 items, each item has a 4-point Likert scale (1 to 4) and response descriptors vary. The item responses are summed for the total score which can range from 8-32. Higher score indicate higher satisfaction.

  3. Interpersonal Relationship with Navigator (PSN-I) [ Time Frame: 6 months ]
    The PSN-I is a validated 9-item scale with strong psychometric properties in samples of culturally diverse, underserved patients. For each item the participant can respond, "strongly disagree" =1, "disagree" =2, "are undecided"=3, "agree" =4, or "strongly agree" =5. Total scores are summed and can range from 9 to 45; higher scores indicate higher satisfaction with their interpersonal relationship with the patient navigator.

  4. Change in Family Resource Scale (FRS) [ Time Frame: baseline, 12 months ]
    The FRS is a 30-item scale assessing numerous family needs and factors: growth/support, health/necessities, physical necessities, physical shelter, intra-family support, communication/employment, child care, and personal resources. It is a self-administered instrument with each item being rated on a five-point scale ranging from "not-at-all-adequate" to "almost-always-adequate". Higher scores are more favorable.

  5. Change in Patient Health Questionnaire-2 [PHQ-2} [ Time Frame: baseline, 12 months ]
    The PHQ-2 is a validated 2-question depression screening tool. PHQ-2 score ranges from 0-6 The authors of the measure identified a score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely.

  6. Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) [ Time Frame: baseline, 12 months ]
    The measure consists of 26 Likert-type items, assessing help-seeking attitudes, help-seeking intentions, and mental health stigma, and is scored on a Likert-type scale from 0 (strongly disagree) to 5 (strongly agree). Higher scores are more favorable.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who screen positive on the Survey of Wellbeing of Young Children (SWYC) (3-5 years) OR
  • Children who screen positive on the Pediatric Symptom Checklist-17 (PSC-17) (6-12 years) OR
  • Children 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
  • Children with active psychosis
  • Children with safety concerns requiring emergency mental health services.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569449


Contacts
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Contact: Emily Feinberg, ScD, CPNP 617-414-1425 emfeinbe@bu.edu
Contact: Lisa Fortuna, MD, MPH 617-414-4754 lisa.fortuna@bmc.org

Locations
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United States, Massachusetts
DotHouse Health Recruiting
Dorchester, Massachusetts, United States, 02122
Sponsors and Collaborators
Boston Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Emily Feinberg, ScD, CPNP Boston Medical Center and Boston University SPH

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03569449     History of Changes
Other Study ID Numbers: H-37634
1R01MH117123-01 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
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