Study Results
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View full resultsBasic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2019-06-24
2024-06-21
Brief Summary
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Detailed Description
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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 electronic health record (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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Group 1- Goat
Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
Group 2- Cow
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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
Group 3- Horse
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
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
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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).
Group 4- Pig
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
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
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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
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).
Group 5- Sheep
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Group 6- Llama
Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
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
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Group 7- Cat
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
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
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
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).
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Group 8- Dog
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
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
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
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).
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
Group 9- Donkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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.
Group 10- Bear
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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
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.
Group 11- Tiger
Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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).
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.
Group 12- Lion
Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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
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).
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.
Group 13- Monkey
Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Group 14- Zebra
Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Group 15- Elephant
Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
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).
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Group 16- Giraffe
Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
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
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).
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Interventions
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Usual care
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
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
Standard pediatric surveillance
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visits
Family Partners will utilize a predetermined schedule of contacts with families
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
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).
:Individually-tailored visits
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Eligibility Criteria
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Inclusion Criteria
* 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 with active psychosis
* Children with safety concerns requiring emergency mental health services.
3 Years
12 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
National Institute of Mental Health (NIMH)
NIH
Responsible Party
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Principal Investigators
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Emily Feinberg, ScD, CPNP
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center and Boston University SPH
Locations
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DotHouse Health
Dorchester, Massachusetts, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H-37634
Identifier Type: -
Identifier Source: org_study_id
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