Health BehaviorNCT03569449
Family Partner Navigation for Children
A study testing Clinic-based visits, Standard pediatric surveillance and Structured, schedule-based visits in people with Health Behavior, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Clinic-based visits, Standard pediatric surveillance and Structured, schedule-based visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing a Paraprofessional, Family Partner Navigation Model for Children
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
Read the 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 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
- Health Behavior
- Being tested
- Usual care, Clinic-based visits, Standard pediatric surveillance, Structured, schedule-based visits, Enhanced pediatric surveillance
- Keywords
- 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
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
Clinic-based visitsBehavioural
Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits
Standard pediatric surveillanceBehavioural
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Structured, schedule-based visitsBehavioural
Family Partners will utilize a predetermined schedule of contacts with families
Enhanced pediatric surveillanceBehavioural
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 coordinationBehavioural
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 visitsBehavioural
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 visitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Goat | Experimental | Clinic-based visit, usual care, standard pediatric surveillance, and structured visits Receives: Behavioral: Usual care; Behavioral: Clinic-based visits; Behavioral: Standard pediatric surveillance; Behavioral: Structured, schedule-based visits |
| Group 2- Cow | Experimental | Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits Receives: Behavioral: Usual care; Behavioral: Clinic-based visits; Behavioral: Structured, schedule-based visits; Behavioral: Enhanced pediatric surveillance |
| Group 3- Horse | Experimental | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits Receives: Behavioral: Clinic-based visits; Behavioral: Standard pediatric surveillance; Behavioral: Structured, schedule-based visits; Behavioral: Technology enhanced care coordination |
| Group 4- Pig | Experimental | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits Receives: Behavioral: Clinic-based visits; Behavioral: Structured, schedule-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: Technology enhanced care coordination |
| Group 5- Sheep | Experimental | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits Receives: Behavioral: Usual care; Behavioral: Clinic-based visits; Behavioral: Standard pediatric surveillance; Behavioral: :Individually-tailored visits |
| Group 6- Llama | Experimental | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits Receives: Behavioral: Usual care; Behavioral: Clinic-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: :Individually-tailored visits |
| Group 7- Cat | Experimental | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits Receives: Behavioral: Clinic-based visits; Behavioral: Standard pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: :Individually-tailored visits |
| Group 8- Dog | Experimental | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits Receives: Behavioral: Clinic-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: :Individually-tailored visits |
| Group 9- Donkey | Experimental | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits Receives: Behavioral: Usual care; Behavioral: Standard pediatric surveillance; Behavioral: Structured, schedule-based visits; Behavioral: Clinic-based visits and community visits |
| Group 10- Bear | Experimental | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits Receives: Behavioral: Usual care; Behavioral: Structured, schedule-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: Clinic-based visits and community visits |
| Group 11- Tiger | Experimental | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits Receives: Behavioral: Standard pediatric surveillance; Behavioral: Structured, schedule-based visits; Behavioral: Technology enhanced care coordination; Behavioral: Clinic-based visits and community visits |
| Group 12- Lion | Experimental | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits Receives: Behavioral: Structured, schedule-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: Clinic-based visits and community visits |
| Group 13- Monkey | Experimental | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits Receives: Behavioral: Usual care; Behavioral: Standard pediatric surveillance; Behavioral: :Individually-tailored visits; Behavioral: Clinic-based visits and community visits |
| Group 14- Zebra | Experimental | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits Receives: Behavioral: Usual care; Behavioral: Enhanced pediatric surveillance; Behavioral: :Individually-tailored visits; Behavioral: Clinic-based visits and community visits |
| Group 15- Elephant | Experimental | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits Receives: Behavioral: Standard pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: :Individually-tailored visits; Behavioral: Clinic-based visits and community visits |
| Group 16- Giraffe | Experimental | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits Receives: Behavioral: Enhanced pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: :Individually-tailored visits; Behavioral: Clinic-based visits and community visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Completion
Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Measured: 6 months
Time to Goal Completion
Time to goal completion obtained from the electronic health record including Family Partner's template documentation.
Measured: 18 months
Secondary outcomes (7)
Change in the Survey of Well-being of Young Children (SWYC)
The Survey of Well-being of Young Children (SWYC) screens for cognitive, motor, language, and social-emotional development among children up to 5½ years of age. Behavioral symptoms were tracked using the SWYC's subscale called the Preschool Pediatric Symptom Checklist (PPSC). The PPSC is an 18-item questionnaire. The total score is summed and can range from 0 to 36. A PPSC total score of 9 or greater indicates that a child is "at risk". Change in the SWYC's PPSC subscale was calculated by finding the difference between the 6 month score and baseline. Participants with increased risk at 6-month is a change from a PPSC total score of below 9 at baseline (low risk) to a score of 9 or greater at 6-month (at risk). Decreased risk at 6-month is a change from a PPSC total score at or above 9 at baseline (at risk) to one below 9 at 6-month follow-up (low risk). No change is either both scores remained "at risk" or both scores remained "low risk".
Measured: baseline, 6 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 as a sum each of the 17-item level scores, 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 or "at risk". Change in the Pediatric Symptom Checklist-17 (PSC-17) total score was calculated between the baseline and 6-month follow-up. Increased risk at 6-month is a change from a PSC-17 total score from below 15 at baseline to a score of 15 or greater at 6-month. Decreased risk at 6-month is a change from a PPSC total score at or above 15 at baseline to one below 15 at 6-month follow-up. No change is either both scores remained "at risk" or both scores remained "low risk".
Measured: baseline, 6 months
Satisfaction With Hospital Care Questionnaire (SHCQ)
The Satisfaction with Hospital Care Questionnaire (SHCQ) addresses aspects of hospital care. Three subscales were used: Information (6 questions), Patient Autonomy (2 questions), and Emotional Support (3 questions). Each question is self rated on a scale of 1 to 10 where 1=poor and 10 = excellent. Total scores were summed across the three subscales. Total scores can range from 11 to 110. Higher scores suggest greater satisfaction with hospital care.
Measured: 6 months
Interpersonal Relationship With Navigator (PSN-I)
The Interpersonal Relationship with Navigator (PSN-I) tool 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 across the 9-items and can range from 9 to 45; higher scores indicate higher satisfaction with their interpersonal relationship with the patient navigator.
Measured: 6 months
Change in Family Resource Scale (FRS)
The Family Resource Scale (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. Each item is rated on a five-point scale ranging from "not-at-all-adequate" to "almost-always-adequate". Total scores were calculated by a sum across the 30-items. The minimum score is 30 and the maximum score is 150. Higher scores indicate more adequate levels of family resources.
Change in score was calculated by taking the difference between total scores at baseline and 6 months. This was done by subtracting 6 month scores from baseline scores for each participant. Of note, a negative change value is due to a higher scores at baseline than at 6 months.
The differences were averaged across the participants in each condition.
Measured: baseline, 6 months
Change in Patient Health Questionnaire-2 (PHQ-2)
The Patient Health Questionnaire-2 (PHQ-2) is a validated 2-question depression screening tool. PHQ-2 total score ranges from 0-6. The authors of the measure identified a score of 3 as the optimal cut-point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely.
Change in score was calculated by taking the difference between total scores at baseline and 6 months. This was done by subtracting 6 month scores from baseline scores for each participant. Of note, a negative change value is due to a higher scores at baseline than at 6 months.
The differences were averaged across the participants in each condition.
Measured: baseline, 6 months
Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)
The Parental Attitudes Toward Psychological Services Inventory (PATPSI) 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). Scores can range from 0 to 130. Higher scores are more favorable.
Change in score was calculated by taking the difference between total scores at baseline and 6 months. This was done by subtracting 6 month scores from baseline scores for each participant. Of note, a negative change value is due to a higher scores at baseline than at 6 months.
The differences were averaged across the participants in each condition.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start24 Jun 2019
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Emily Feinberg, ScD, CPNP, Principal investigator, Boston Medical Center and Boston University SPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569449
- Sponsor's protocol ID
- H-37634
- Other IDs
- 1R01MH117123-01
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2018
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31842963
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Paraprofessional, Family Partner Navigation Model for Children
- ClinicalTrials.gov ID
- NCT03569449
- Acronym / sponsor ID
- H-37634
- Conditions
- Health Behavior
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Group 1- Goat | Experimental | Behavioral: Usual care, Behavioral: Clinic-based visits, Behavioral: Standard pediatric surveillance, Behavioral: Structured, schedule-based visitsClinic-based visit, usual care, standard pediatric surveillance, and structured visits |
| Group 2- Cow | Experimental | Behavioral: Usual care, Behavioral: Clinic-based visits, Behavioral: Structured, schedule-based visits, Behavioral: Enhanced pediatric surveillanceClinic-based visit, usual care, enhanced pediatric surveillance, and structured visits |
| Group 3- Horse | Experimental | Behavioral: Clinic-based visits, Behavioral: Standard pediatric surveillance, Behavioral: Structured, schedule-based visits, Behavioral: Technology enhanced care coordinationClinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| Group 4- Pig | Experimental | Behavioral: Clinic-based visits, Behavioral: Structured, schedule-based visits, Behavioral: Enhanced pediatric surveillance, Behavioral: Technology enhanced care coordinationClinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| Group 5- Sheep | Experimental | Behavioral: Usual care, Behavioral: Clinic-based visits, Behavioral: Standard pediatric surveillance, Behavioral: :Individually-tailored visitsClinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| Group 6- Llama | Experimental | Behavioral: Usual care, Behavioral: Clinic-based visits, Behavioral: Enhanced pediatric surveillance, Behavioral: :Individually-tailored visitsClinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| Group 7- Cat | Experimental | Behavioral: Clinic-based visits, Behavioral: Standard pediatric surveillance, Behavioral: Technology enhanced care coordination, Behavioral: :Individually-tailored visitsClinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| Group 8- Dog | Experimental | Behavioral: Clinic-based visits, Behavioral: Enhanced pediatric surveillance, Behavioral: Technology enhanced care coordination, Behavioral: :Individually-tailored visitsClinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| Group 9- Donkey | Experimental | Behavioral: Usual care, Behavioral: Standard pediatric surveillance, Behavioral: Structured, schedule-based visits, Behavioral: Clinic-based visits and community visitsClinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| Group 10- Bear | Experimental | Behavioral: Usual care, Behavioral: Structured, schedule-based visits, Behavioral: Enhanced pediatric surveillance, Behavioral: Clinic-based visits and community visitsClinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| Group 11- Tiger | Experimental | Behavioral: Standard pediatric surveillance, Behavioral: Structured, schedule-based visits, Behavioral: Technology enhanced care coordination, Behavioral: Clinic-based visits and community visitsClinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| Group 12- Lion | Experimental | Behavioral: Structured, schedule-based visits, Behavioral: Enhanced pediatric surveillance, Behavioral: Technology enhanced care coordination, Behavioral: Clinic-based visits and community visitsClinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| Group 13- Monkey | Experimental | Behavioral: Usual care, Behavioral: Standard pediatric surveillance, Behavioral: :Individually-tailored visits, Behavioral: Clinic-based visits and community visitsClinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| Group 14- Zebra | Experimental | Behavioral: Usual care, Behavioral: Enhanced pediatric surveillance, Behavioral: :Individually-tailored visits, Behavioral: Clinic-based visits and community visitsClinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| Group 15- Elephant | Experimental | Behavioral: Standard pediatric surveillance, Behavioral: Technology enhanced care coordination, Behavioral: :Individually-tailored visits, Behavioral: Clinic-based visits and community visitsClinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| Group 16- Giraffe | Experimental | Behavioral: Enhanced pediatric surveillance, Behavioral: Technology enhanced care coordination, Behavioral: :Individually-tailored visits, Behavioral: Clinic-based visits and community visitsClinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careFamily partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software. | Behavioural | Group 1- Goat, Group 10- Bear, Group 13- Monkey, Group 14- Zebra, Group 2- Cow, Group 5- Sheep, Group 6- Llama, Group 9- Donkey |
| Clinic-based visitsFamily partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits | Behavioural | Group 1- Goat, Group 2- Cow, Group 3- Horse, Group 4- Pig, Group 5- Sheep, Group 6- Llama, Group 7- Cat, Group 8- Dog |
| Standard pediatric surveillanceMonitoring is determined by standard pediatric practice. Behavioral screening is usually done annually. | Behavioural | Group 1- Goat, Group 11- Tiger, Group 13- Monkey, Group 15- Elephant, Group 3- Horse, Group 5- Sheep, Group 7- Cat, Group 9- Donkey |
| Structured, schedule-based visitsFamily Partners will utilize a predetermined schedule of contacts with families | Behavioural | Group 1- Goat, Group 10- Bear, Group 11- Tiger, Group 12- Lion, Group 2- Cow, Group 3- Horse, Group 4- Pig, Group 9- Donkey |
| Enhanced pediatric surveillanceIn 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 | Behavioural | Group 10- Bear, Group 12- Lion, Group 14- Zebra, Group 16- Giraffe, Group 2- Cow, Group 4- Pig, Group 6- Llama, Group 8- Dog |
| Technology enhanced care coordinationBehavioral: 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). | Behavioural | Group 11- Tiger, Group 12- Lion, Group 15- Elephant, Group 16- Giraffe, Group 3- Horse, Group 4- Pig, Group 7- Cat, Group 8- Dog |
| :Individually-tailored visitsFamily Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts | Behavioural | Group 13- Monkey, Group 14- Zebra, Group 15- Elephant, Group 16- Giraffe, Group 5- Sheep, Group 6- Llama, Group 7- Cat, Group 8- Dog |
| Clinic-based visits and community visitsIn 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. | Behavioural | Group 10- Bear, Group 11- Tiger, Group 12- Lion, Group 13- Monkey, Group 14- Zebra, Group 15- Elephant, Group 16- Giraffe, Group 9- Donkey |
Primary outcome
Goal Completion
Time frame: 6 months
Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Time to Goal Completion
Time frame: 18 months
Time to goal completion obtained from the electronic health record including Family Partner's template documentation.
7 secondary outcomes
Change in the Survey of Well-being of Young Children (SWYC)
Time frame: baseline, 6 months
Change in Pediatric Symptom Checklist-17 (PSC-17)
Time frame: baseline, 6 months
Satisfaction With Hospital Care Questionnaire (SHCQ)
Time frame: 6 months
Interpersonal Relationship With Navigator (PSN-I)
Time frame: 6 months
Change in Family Resource Scale (FRS)
Time frame: baseline, 6 months
Change in Patient Health Questionnaire-2 (PHQ-2)
Time frame: baseline, 6 months
Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)
Time frame: baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31842963Broder-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Feinberg, ScD, CPNP principal investigator
Boston Medical Center and Boston University SPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based visits, Standard pediatric surveillance and Structured, schedule-based visits in people with Health Behavior, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Completion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.