Family Partner Navigation for Children

Study Overview
=================
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.

Official Title
-----------------
Optimizing a Paraprofessional, Family Partner Navigation Model for Children

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1- Goat<br>Clinic-based visit, usual care, standard pediatric surveillance, and structured visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>|
| Experimental: Group 2- Cow<br>Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>|
| Experimental: Group 3- Horse<br>Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits | Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>|
| Experimental: Group 4- Pig<br>Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits | Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>|
| Experimental: Group 5- Sheep<br>Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>|
| Experimental: Group 6- Llama<br>Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>|
| Experimental: Group 7- Cat<br>Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits | Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>|
| Experimental: Group 8- Dog<br>Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits | Behavioral: Clinic-based visits<br>* Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>|
| Experimental: Group 9- Donkey<br>Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 10- Bear<br>Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 11- Tiger<br>Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits | Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 12- Lion<br>Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits | Behavioral: Structured, schedule-based visits<br>* Family Partners will utilize a predetermined schedule of contacts with families<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 13- Monkey<br>Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 14- Zebra<br>Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits | Behavioral: Usual care<br>* Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.<br>Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 15- Elephant<br>Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits | Behavioral: Standard pediatric surveillance<br>* Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|
| Experimental: Group 16- Giraffe<br>Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits | Behavioral: Enhanced pediatric surveillance<br>* 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<br>Behavioral: Technology enhanced care coordination<br>* 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).<br>Behavioral: :Individually-tailored visits<br>* Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts<br>Behavioral: Clinic-based visits and community visits<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times to services | Time from randomization to 1st behavioral health service encounter obtained from the electronic health record including Family Partner's template documentation | 90 days from randomization | 
| Access to services [Yes/No] | 1st encounter with behavioral health services within 90 days of randomization obtained from the electronic health record including Family Partner's template documentation | 90 days from randomization | 
| Change in the Survey of Well-being of Young Children (SWYC) | 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 | baseline, 12 months | 
| Change in Pediatric Symptom Checklist-17 (PSC-17) | 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. | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in services | ≥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. | 90 days from 1st visit behavioral health services encounter | 
| Satisfaction with Hospital Care Questionnaire (SHCQ) | The SHCQ addresses aspects of care including information, patient autonomy, and emotional support. | 6 months | 
| Interpersonal Relationship with Navigator (PSN-I) | 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. | 6 months | 
| Change in Family Resource Scale (FRS) | 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. | baseline, 12 months | 
| Change in Patient Health Questionnaire-2 [PHQ-2} | 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. | baseline, 12 months | 
| Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 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. | baseline, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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