Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH117123-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Goat | Experimental | Clinic-based visit, usual care, standard pediatric surveillance, and structured visits |
|
| Group 2- Cow | Experimental | Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits |
|
| Group 3- Horse | Experimental | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
|
| Group 4- Pig | Experimental | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software. |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Completion | Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation. | 6 months |
| Time to Goal Completion | Time to goal completion obtained from the electronic health record including Family Partner's template documentation. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
Not provided
Inclusion Criteria:
All children who are 3-12 years old:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Feinberg, ScD, CPNP | Boston Medical Center and Boston University SPH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DotHouse Health | Dorchester | Massachusetts | 02122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31842963 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Both a parent or legal guardian and a child were included in the dyad. Dyads were randomized as a single unit to a condition.
The total enrolled refers to the number of dyads.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1- Goat | Clinic-based visit, usual care, standard pediatric surveillance, and structured visits |
| FG001 | Group 2- Cow | Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Group 5- Sheep | Experimental | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
|
| Group 6- Llama | Experimental | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
|
| Group 7- Cat | Experimental | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
|
| Group 8- Dog | Experimental | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
|
| Group 9- Donkey | Experimental | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
|
| Group 10- Bear | Experimental | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
|
| Group 11- Tiger | Experimental | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
|
| Group 12- Lion | Experimental | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
|
| Group 13- Monkey | Experimental | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
|
| Group 14- Zebra | Experimental | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
|
| Group 15- Elephant | Experimental | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
|
| Group 16- Giraffe | Experimental | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
| Clinic-based visits | Behavioral | 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 | Behavioral | Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually. |
|
| Structured, schedule-based visits | Behavioral | Family Partners will utilize a predetermined schedule of contacts with families |
|
| Enhanced pediatric surveillance | Behavioral | 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 | 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 | Behavioral | 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 | Behavioral | 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. |
|
| 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". | 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. | 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. | 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. | 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. | 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. | baseline, 6 months |
| FG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| FG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| FG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| FG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| FG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| FG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| FG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| FG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| FG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| FG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| FG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| FG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| FG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| FG015 | Group 16- Giraffe | Clinic & community visits, technology-enhanced care, enhanced pediatric surveillance, & individually-tailored visits |
| COMPLETED |
|
| NOT COMPLETED |
|
|
We did not collect data on parent/guardian age, race, ethnicity or gender therefore baseline characteristic data is based on the child of the dyad.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- Goat | Clinic-based visit, usual care, standard pediatric surveillance, and structured visits |
| BG001 | Group 2- Cow | Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits |
| BG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| BG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| BG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| BG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| BG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| BG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| BG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| BG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| BG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| BG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| BG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| BG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| BG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| BG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
| BG016 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | Child sex/gender | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Child race/ethnicity | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Goal Completion | Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation. | Data are available for all 312 dyads. | Posted | Count of Participants | Participants | 6 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Goal Completion | Time to goal completion obtained from the electronic health record including Family Partner's template documentation. | This outcome was calculated for dyads with successful goal completion. This measure examines goal completion up to 18 months from baseline. | Posted | Median | Full Range | days | 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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". | This survey is appropriate for children 3-5 years of age therefore administered to a subset of children. In addition, the SWYC was part of the "enhanced" factor and therefore was only administered in 8 out of 16 conditions. | Posted | Count of Participants | Participants | baseline, 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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". | This survey is appropriate for children 4-18 years old. It was administered to eligible children 5-12 years old in the study. In addition, the PSC-17 was part of the "enhanced" factor and therefore was only administered in 8 out of 16 conditions. | Posted | Count of Participants | Participants | baseline, 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time frame. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time frame. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time frame. There were also 4 parents who completed less than 10% of the survey due to time constraints. Parents missing either a baseline or 6 month score could not be analyzed for a change in score. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | This survey was part of the "enhanced" factor and therefore was only administered to 8 out of 16 conditions. This survey was administered to the parents/guardians. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time point. There were also 4 parents who completed less than 10% of the survey due to time constraints. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 months |
|
18 months
Adverse events were non-systematically assessed only for children. There were no adverse events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1- Goat | Clinic-based visit, usual care, standard pediatric surveillance, and structured visits | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Group 2- Cow | Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits | 0 | 21 | 0 | 21 | 0 | 21 |
| EG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits | 0 | 17 | 0 | 17 | 0 | 17 |
| EG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits | 0 | 20 | 0 | 20 | 0 | 20 |
| EG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits | 0 | 21 | 0 | 21 | 0 | 21 |
| EG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits | 0 | 20 | 0 | 20 | 0 | 20 |
| EG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits | 0 | 18 | 0 | 18 | 0 | 18 |
| EG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits | 0 | 19 | 0 | 19 | 0 | 19 |
| EG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Feinberg, ScD, CPNP | Boston Medical Center, Boston University School of Public Health | 617-414-1425 | emfeinbe@bu.edu |
| Oct 16, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2023 | Oct 16, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| Female |
|
| Refused to answer |
|
| Asian |
|
| White |
|
| Unknown |
|
| More than one race |
|
| Other |
|
| Hispanic |
|
| Group 5- Sheep |
Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
| OG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
| OG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
| Group 4- Pig |
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
| OG003 |
| Group 4- Pig |
Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
| OG002 | Group 3- Horse | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
| OG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|
| Group 3- Horse |
Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG003 | Group 4- Pig | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG004 | Group 5- Sheep | Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits |
| OG005 | Group 6- Llama | Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits |
| OG006 | Group 7- Cat | Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG007 | Group 8- Dog | Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG008 | Group 9- Donkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits |
| OG009 | Group 10- Bear | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits |
| OG010 | Group 11- Tiger | Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits |
| OG011 | Group 12- Lion | Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits |
| OG012 | Group 13- Monkey | Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits |
| OG013 | Group 14- Zebra | Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits |
| OG014 | Group 15- Elephant | Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits |
| OG015 | Group 16- Giraffe | Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits |
|
|