Health Behavior
Conditions
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
Brief summary
Family Navigation (FN), an evidence-based care management strategy which is a promising intervention to help low income and minority families access timely mental health services. Despite significant evidence supporting the effectiveness of FN, concerns exist about the ability to disseminate FN to a broad population due to inefficiency and cost. The proposed study employs an innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The investigators will conduct a randomized experiment to assess the individual components of FN and identify which components and component levels have greatest effect on access to, and engagement in, diagnostic and treatment services for children with mental health disorders. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden
Detailed description
The goal of this study is to determine the optimal delivery of a Family Navigation (FN) model that increases engagement in services to address children's behavioral health. While there is strong evidence that navigation decreases barriers to care for low income and minority families, little is known about which specific components contribute to its efficacy. The investigators propose to use MOST, a pioneering, engineering-inspired framework, to assess the performance of individual intervention components and their interactions. Delivery of FN will be systematically varied across four components, each of which is represented by a separate factor in the 2x2x2x2 factorial study design. Specifically, each family will be randomly assigned to one of two conditions within each of four factors or delivery strategies, defining sixteen separate experimental conditions. Strategies include: (A) technology-assisted delivery of care coordination using an innovative, web-based platform called Act.MD (compared to usual care); (B) clinic based FN + community-based (compared to clinic-based only); (C) enhanced symptom tracking using more frequent behavioral symptom tracking (compared to standard pediatric surveillance); and (d) individually-tailored visits (compared to a predetermined schedule of contacts). All children will be followed through the 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.
Interventions
Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits
Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
Family Partners will utilize a predetermined schedule of contacts with families
In Massachusetts, behavioral screening is mandated at every pediatric visit, which for children in the target population (ages 3-12 years) is annually. With enhanced monitoring, Family Partners will screen children using validated instruments quarterly and communicate results to the child's care team
Behavioral: technology enhanced care coordination 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).
Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
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.
Sponsors
Study design
Eligibility
Inclusion criteria
All children who are 3-12 years old: * who screen positive on the Survey of Wellbeing of Young Children (SWYC) (3-5 years) OR * who screen positive on the Pediatric Symptom Checklist-17 (PSC-17) (6-12 years) OR * whose parents indicate a behavioral health concern during any pediatric visit
Exclusion criteria
* Children who are already actively engaged in behavioral health specialty care services, defined as having had a behavioral health visit in the last 30 days, who do not require new additional services * Children with active psychosis * Children with safety concerns requiring emergency mental health services.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal Completion | 6 months | Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation. |
| Time to Goal Completion | 18 months | Time to goal completion obtained from the electronic health record including Family Partner's template documentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Hospital Care Questionnaire (SHCQ) | 6 months | 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. |
| Interpersonal Relationship With Navigator (PSN-I) | 6 months | 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. |
| Change in the Survey of Well-being of Young Children (SWYC) | baseline, 6 months | 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. |
| Change in Patient Health Questionnaire-2 (PHQ-2) | baseline, 6 months | 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. |
| Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | baseline, 6 months | 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. |
| Change in Family Resource Scale (FRS) | baseline, 6 months | 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. |
| Change in Pediatric Symptom Checklist-17 (PSC-17) | baseline, 6 months | Scores from the Pediatric Symptom Checklist-17 (PSC-17) will be used to assess child symptoms. The PSC-17 is a 17-item psychosocial screen designed to recognize cognitive, emotional, and behavioral problems. A value of 0 is assigned to Never, 1 to Sometimes, and 2 to Often. The total score is calculated 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. |
Countries
United States
Participant flow
Recruitment details
The total enrolled refers to the number of dyads.
Pre-assignment details
Both a parent or legal guardian and a child were included in the dyad. Dyads were randomized as a single unit to a condition.
Participants by arm
| Arm | Count |
|---|---|
| Group 1- Goat Clinic-based visit, usual care, standard pediatric surveillance, and structured visits | 20 |
| Group 2- Cow Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits | 24 |
| Group 3- Horse Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits | 18 |
| Group 4- Pig Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits | 19 |
| Group 5- Sheep Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits | 21 |
| Group 6- Llama Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits | 17 |
| Group 7- Cat Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits | 19 |
| Group 8- Dog Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits | 20 |
| Group 9- Donkey Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits | 19 |
| Group 10- Bear Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits | 21 |
| Group 11- Tiger Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits | 20 |
| Group 12- Lion Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits | 19 |
| Group 13- Monkey Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits | 19 |
| Group 14- Zebra Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits | 18 |
| Group 15- Elephant Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits | 19 |
| Group 16- Giraffe Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits | 19 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2- Cow | Group 1- Goat | Group 3- Horse | Group 4- Pig | Group 5- Sheep | Group 6- Llama | Group 7- Cat | Group 8- Dog | Group 9- Donkey | Group 10- Bear | Group 11- Tiger | Group 12- Lion | Group 13- Monkey | Group 14- Zebra | Group 15- Elephant | Group 16- Giraffe | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 7.0 years STANDARD_DEVIATION 2.9 | 6.6 years STANDARD_DEVIATION 3 | 7.2 years STANDARD_DEVIATION 3 | 7.1 years STANDARD_DEVIATION 3.5 | 6.8 years STANDARD_DEVIATION 3.5 | 7.4 years STANDARD_DEVIATION 3.8 | 6.6 years STANDARD_DEVIATION 2.9 | 6.6 years STANDARD_DEVIATION 3.1 | 7.2 years STANDARD_DEVIATION 2.8 | 6.7 years STANDARD_DEVIATION 3.3 | 7.4 years STANDARD_DEVIATION 3.1 | 6.8 years STANDARD_DEVIATION 3.5 | 7.3 years STANDARD_DEVIATION 3.3 | 7.4 years STANDARD_DEVIATION 3.3 | 6.7 years STANDARD_DEVIATION 3.1 | 7.3 years STANDARD_DEVIATION 2.7 | 7.0 years STANDARD_DEVIATION 3.1 |
| Race/Ethnicity, Customized Asian | 7 Participants | 6 Participants | 2 Participants | 6 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants | 5 Participants | 85 Participants |
| Race/Ethnicity, Customized Black/African Am | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 6 Participants | 3 Participants | 54 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 8 Participants | 9 Participants | 9 Participants | 10 Participants | 7 Participants | 7 Participants | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 6 Participants | 8 Participants | 7 Participants | 8 Participants | 134 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 11 Participants |
| Region of Enrollment United States | 24 participants | 20 participants | 18 participants | 19 participants | 21 participants | 17 participants | 19 participants | 20 participants | 19 participants | 21 participants | 20 participants | 19 participants | 19 participants | 18 participants | 19 participants | 19 participants | 312 participants |
| Sex/Gender, Customized Female | 7 Participants | 8 Participants | 6 Participants | 8 Participants | 6 Participants | 4 Participants | 3 Participants | 8 Participants | 9 Participants | 6 Participants | 11 Participants | 11 Participants | 11 Participants | 10 Participants | 7 Participants | 6 Participants | 121 Participants |
| Sex/Gender, Customized Male | 17 Participants | 12 Participants | 12 Participants | 11 Participants | 15 Participants | 12 Participants | 16 Participants | 12 Participants | 10 Participants | 14 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 12 Participants | 13 Participants | 187 Participants |
| Sex/Gender, Customized Refused to answer | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 24 | 0 / 18 | 0 / 19 | 0 / 21 | 0 / 17 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 21 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 24 | 0 / 18 | 0 / 19 | 0 / 21 | 0 / 17 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 21 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 24 | 0 / 18 | 0 / 19 | 0 / 21 | 0 / 17 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 21 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 18 | 0 / 19 | 0 / 19 |
Outcome results
Goal Completion
Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Time frame: 6 months
Population: Data are available for all 312 dyads.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1- Goat | Goal Completion | 9 Participants |
| Group 2- Cow | Goal Completion | 9 Participants |
| Group 3- Horse | Goal Completion | 7 Participants |
| Group 4- Pig | Goal Completion | 9 Participants |
| Group 5- Sheep | Goal Completion | 7 Participants |
| Group 6- Llama | Goal Completion | 6 Participants |
| Group 7- Cat | Goal Completion | 2 Participants |
| Group 8- Dog | Goal Completion | 4 Participants |
| Group 9- Donkey | Goal Completion | 7 Participants |
| Group 10- Bear | Goal Completion | 4 Participants |
| Group 11- Tiger | Goal Completion | 6 Participants |
| Group 12- Lion | Goal Completion | 6 Participants |
| Group 13- Monkey | Goal Completion | 10 Participants |
| Group 14- Zebra | Goal Completion | 3 Participants |
| Group 15- Elephant | Goal Completion | 5 Participants |
| Group 16- Giraffe | Goal Completion | 6 Participants |
Time to Goal Completion
Time to goal completion obtained from the electronic health record including Family Partner's template documentation.
Time frame: 18 months
Population: This outcome was calculated for dyads with successful goal completion. This measure examines goal completion up to 18 months from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1- Goat | Time to Goal Completion | 168 days |
| Group 2- Cow | Time to Goal Completion | 159.5 days |
| Group 3- Horse | Time to Goal Completion | 179 days |
| Group 4- Pig | Time to Goal Completion | 177 days |
| Group 5- Sheep | Time to Goal Completion | 184 days |
| Group 6- Llama | Time to Goal Completion | 193 days |
| Group 7- Cat | Time to Goal Completion | 218.5 days |
| Group 8- Dog | Time to Goal Completion | 191 days |
| Group 9- Donkey | Time to Goal Completion | 179 days |
| Group 10- Bear | Time to Goal Completion | 182 days |
| Group 11- Tiger | Time to Goal Completion | 190 days |
| Group 12- Lion | Time to Goal Completion | 191 days |
| Group 13- Monkey | Time to Goal Completion | 173 days |
| Group 14- Zebra | Time to Goal Completion | 268.5 days |
| Group 15- Elephant | Time to Goal Completion | 190.5 days |
| Group 16- Giraffe | Time to Goal Completion | 192.5 days |
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- Goat | Change in Family Resource Scale (FRS) | 0.0 score on a scale | Standard Deviation 0.6 |
| Group 2- Cow | Change in Family Resource Scale (FRS) | 0.3 score on a scale | Standard Deviation 1.2 |
| Group 3- Horse | Change in Family Resource Scale (FRS) | 0.1 score on a scale | Standard Deviation 0.4 |
| Group 4- Pig | Change in Family Resource Scale (FRS) | 0.1 score on a scale | Standard Deviation 0.7 |
| Group 5- Sheep | Change in Family Resource Scale (FRS) | 0.1 score on a scale | Standard Deviation 9.7 |
| Group 6- Llama | Change in Family Resource Scale (FRS) | 0.0 score on a scale | Standard Deviation 0.4 |
| Group 7- Cat | Change in Family Resource Scale (FRS) | 0.1 score on a scale | Standard Deviation 0.7 |
| Group 8- Dog | Change in Family Resource Scale (FRS) | 0.6 score on a scale | Standard Deviation 0.9 |
| Group 9- Donkey | Change in Family Resource Scale (FRS) | 0.8 score on a scale | Standard Deviation 0.9 |
| Group 10- Bear | Change in Family Resource Scale (FRS) | 0.2 score on a scale | Standard Deviation 0.6 |
| Group 11- Tiger | Change in Family Resource Scale (FRS) | 0.1 score on a scale | Standard Deviation 0.5 |
| Group 12- Lion | Change in Family Resource Scale (FRS) | 0.2 score on a scale | Standard Deviation 0.6 |
| Group 13- Monkey | Change in Family Resource Scale (FRS) | 0.0 score on a scale | Standard Deviation 0.7 |
| Group 14- Zebra | Change in Family Resource Scale (FRS) | 0.0 score on a scale | Standard Deviation 0.4 |
| Group 15- Elephant | Change in Family Resource Scale (FRS) | 0.2 score on a scale | Standard Deviation 0.6 |
| Group 16- Giraffe | Change in Family Resource Scale (FRS) | 0.5 score on a scale | Standard Deviation 0.8 |
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 2- Cow | Change in Patient Health Questionnaire-2 (PHQ-2) | 0.2 score on a scale | Standard Deviation 1.6 |
| Group 4- Pig | Change in Patient Health Questionnaire-2 (PHQ-2) | -0.3 score on a scale | Standard Deviation 0.5 |
| Group 6- Llama | Change in Patient Health Questionnaire-2 (PHQ-2) | -1.1 score on a scale | Standard Deviation 2.3 |
| Group 8- Dog | Change in Patient Health Questionnaire-2 (PHQ-2) | -0.2 score on a scale | Standard Deviation 2.4 |
| Group 10- Bear | Change in Patient Health Questionnaire-2 (PHQ-2) | -0.5 score on a scale | Standard Deviation 2 |
| Group 12- Lion | Change in Patient Health Questionnaire-2 (PHQ-2) | -0.2 score on a scale | Standard Deviation 1.6 |
| Group 14- Zebra | Change in Patient Health Questionnaire-2 (PHQ-2) | 0.4 score on a scale | Standard Deviation 1.1 |
| Group 16- Giraffe | Change in Patient Health Questionnaire-2 (PHQ-2) | 0.9 score on a scale | Standard Deviation 2 |
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2- Cow | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 1 Participants |
| Group 2- Cow | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 9 Participants |
| Group 2- Cow | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 1 Participants |
| Group 4- Pig | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 5 Participants |
| Group 4- Pig | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 2 Participants |
| Group 4- Pig | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 0 Participants |
| Group 6- Llama | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 4 Participants |
| Group 6- Llama | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 1 Participants |
| Group 6- Llama | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 0 Participants |
| Group 8- Dog | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 1 Participants |
| Group 8- Dog | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 0 Participants |
| Group 8- Dog | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 6 Participants |
| Group 10- Bear | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 1 Participants |
| Group 10- Bear | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 3 Participants |
| Group 10- Bear | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 5 Participants |
| Group 12- Lion | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 0 Participants |
| Group 12- Lion | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 0 Participants |
| Group 12- Lion | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 5 Participants |
| Group 14- Zebra | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 1 Participants |
| Group 14- Zebra | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 0 Participants |
| Group 14- Zebra | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 5 Participants |
| Group 16- Giraffe | Change in Pediatric Symptom Checklist-17 (PSC-17) | Increased risk | 1 Participants |
| Group 16- Giraffe | Change in Pediatric Symptom Checklist-17 (PSC-17) | Decreased risk | 2 Participants |
| Group 16- Giraffe | Change in Pediatric Symptom Checklist-17 (PSC-17) | No change in risk | 3 Participants |
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- Goat | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -1.0 score on a scale | Standard Deviation 5 |
| Group 2- Cow | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 1.2 score on a scale | Standard Deviation 8.9 |
| Group 3- Horse | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 5.1 score on a scale | Standard Deviation 5.9 |
| Group 4- Pig | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 0.5 score on a scale | Standard Deviation 5.3 |
| Group 5- Sheep | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 1.3 score on a scale | Standard Deviation 6.3 |
| Group 6- Llama | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 0.3 score on a scale | Standard Deviation 12.1 |
| Group 7- Cat | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -3.6 score on a scale | Standard Deviation 6.1 |
| Group 8- Dog | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -1.3 score on a scale | Standard Deviation 8.2 |
| Group 9- Donkey | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -4.5 score on a scale | Standard Deviation 7.9 |
| Group 10- Bear | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -0.2 score on a scale | Standard Deviation 9 |
| Group 11- Tiger | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -3.0 score on a scale | Standard Deviation 8 |
| Group 12- Lion | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | 1.2 score on a scale | Standard Deviation 6.1 |
| Group 13- Monkey | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -0.5 score on a scale | Standard Deviation 8.1 |
| Group 14- Zebra | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -2.3 score on a scale | Standard Deviation 8 |
| Group 15- Elephant | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -1.1 score on a scale | Standard Deviation 6.5 |
| Group 16- Giraffe | Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) | -2.2 score on a scale | Standard Deviation 9.8 |
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2- Cow | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 3 Participants |
| Group 2- Cow | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 0 Participants |
| Group 2- Cow | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 1 Participants |
| Group 4- Pig | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 1 Participants |
| Group 4- Pig | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 4 Participants |
| Group 4- Pig | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 1 Participants |
| Group 6- Llama | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 0 Participants |
| Group 6- Llama | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 1 Participants |
| Group 6- Llama | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 2 Participants |
| Group 8- Dog | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 2 Participants |
| Group 8- Dog | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 0 Participants |
| Group 8- Dog | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 4 Participants |
| Group 10- Bear | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 0 Participants |
| Group 10- Bear | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 0 Participants |
| Group 10- Bear | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 4 Participants |
| Group 12- Lion | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 1 Participants |
| Group 12- Lion | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 1 Participants |
| Group 12- Lion | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 4 Participants |
| Group 14- Zebra | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 1 Participants |
| Group 14- Zebra | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 0 Participants |
| Group 14- Zebra | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 2 Participants |
| Group 16- Giraffe | Change in the Survey of Well-being of Young Children (SWYC) | Decreased risk | 1 Participants |
| Group 16- Giraffe | Change in the Survey of Well-being of Young Children (SWYC) | No change in risk | 3 Participants |
| Group 16- Giraffe | Change in the Survey of Well-being of Young Children (SWYC) | Increased risk | 1 Participants |
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.
Time frame: 6 months
Population: There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- Goat | Interpersonal Relationship With Navigator (PSN-I) | 31.4 score on a scale | Standard Deviation 14.6 |
| Group 2- Cow | Interpersonal Relationship With Navigator (PSN-I) | 35.9 score on a scale | Standard Deviation 11.1 |
| Group 3- Horse | Interpersonal Relationship With Navigator (PSN-I) | 30.6 score on a scale | Standard Deviation 12.3 |
| Group 4- Pig | Interpersonal Relationship With Navigator (PSN-I) | 31.4 score on a scale | Standard Deviation 13.3 |
| Group 5- Sheep | Interpersonal Relationship With Navigator (PSN-I) | 30.4 score on a scale | Standard Deviation 13.1 |
| Group 6- Llama | Interpersonal Relationship With Navigator (PSN-I) | 33.4 score on a scale | Standard Deviation 13.3 |
| Group 7- Cat | Interpersonal Relationship With Navigator (PSN-I) | 32.1 score on a scale | Standard Deviation 12.8 |
| Group 8- Dog | Interpersonal Relationship With Navigator (PSN-I) | 30.4 score on a scale | Standard Deviation 10.8 |
| Group 9- Donkey | Interpersonal Relationship With Navigator (PSN-I) | 30.5 score on a scale | Standard Deviation 13.4 |
| Group 10- Bear | Interpersonal Relationship With Navigator (PSN-I) | 32.2 score on a scale | Standard Deviation 11.5 |
| Group 11- Tiger | Interpersonal Relationship With Navigator (PSN-I) | 33.1 score on a scale | Standard Deviation 12.7 |
| Group 12- Lion | Interpersonal Relationship With Navigator (PSN-I) | 26.7 score on a scale | Standard Deviation 12.9 |
| Group 13- Monkey | Interpersonal Relationship With Navigator (PSN-I) | 32.9 score on a scale | Standard Deviation 10.6 |
| Group 14- Zebra | Interpersonal Relationship With Navigator (PSN-I) | 27.2 score on a scale | Standard Deviation 12.9 |
| Group 15- Elephant | Interpersonal Relationship With Navigator (PSN-I) | 34.3 score on a scale | Standard Deviation 10.7 |
| Group 16- Giraffe | Interpersonal Relationship With Navigator (PSN-I) | 26.5 score on a scale | Standard Deviation 11.4 |
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.
Time frame: 6 months
Population: There were 75 parents who could not be reached through telephone calls for survey administration at the 6-month time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- Goat | Satisfaction With Hospital Care Questionnaire (SHCQ) | 90.4 score on a scale | Standard Deviation 18.5 |
| Group 2- Cow | Satisfaction With Hospital Care Questionnaire (SHCQ) | 91.6 score on a scale | Standard Deviation 15.5 |
| Group 3- Horse | Satisfaction With Hospital Care Questionnaire (SHCQ) | 91.9 score on a scale | Standard Deviation 12 |
| Group 4- Pig | Satisfaction With Hospital Care Questionnaire (SHCQ) | 96.4 score on a scale | Standard Deviation 10.1 |
| Group 5- Sheep | Satisfaction With Hospital Care Questionnaire (SHCQ) | 92.9 score on a scale | Standard Deviation 13.1 |
| Group 6- Llama | Satisfaction With Hospital Care Questionnaire (SHCQ) | 89.3 score on a scale | Standard Deviation 18.8 |
| Group 7- Cat | Satisfaction With Hospital Care Questionnaire (SHCQ) | 83.8 score on a scale | Standard Deviation 19 |
| Group 8- Dog | Satisfaction With Hospital Care Questionnaire (SHCQ) | 92.5 score on a scale | Standard Deviation 17.4 |
| Group 9- Donkey | Satisfaction With Hospital Care Questionnaire (SHCQ) | 90.9 score on a scale | Standard Deviation 20.5 |
| Group 10- Bear | Satisfaction With Hospital Care Questionnaire (SHCQ) | 83.6 score on a scale | Standard Deviation 25 |
| Group 11- Tiger | Satisfaction With Hospital Care Questionnaire (SHCQ) | 86.8 score on a scale | Standard Deviation 21.2 |
| Group 12- Lion | Satisfaction With Hospital Care Questionnaire (SHCQ) | 89.7 score on a scale | Standard Deviation 16.2 |
| Group 13- Monkey | Satisfaction With Hospital Care Questionnaire (SHCQ) | 83.4 score on a scale | Standard Deviation 17.2 |
| Group 14- Zebra | Satisfaction With Hospital Care Questionnaire (SHCQ) | 94.1 score on a scale | Standard Deviation 14.7 |
| Group 15- Elephant | Satisfaction With Hospital Care Questionnaire (SHCQ) | 87.5 score on a scale | Standard Deviation 22.9 |
| Group 16- Giraffe | Satisfaction With Hospital Care Questionnaire (SHCQ) | 87.3 score on a scale | Standard Deviation 24 |