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Family Partner Navigation for Children

Optimizing a Paraprofessional, Family Partner Navigation Model for Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03569449
Enrollment
312
Registered
2018-06-26
Start date
2019-06-24
Completion date
2024-06-21
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

Family navigation, Family partners, Multiphase optimization strategy (MOST), Pediatric Symptom Checklist-17, Survey of Wellbeing of Young children (SWYC), Family Resource Scale, Federally qualified community health center

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

BEHAVIORALUsual care

Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.

BEHAVIORALClinic-based visits

Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits

BEHAVIORALStandard pediatric surveillance

Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.

BEHAVIORALStructured, schedule-based visits

Family Partners will utilize a predetermined schedule of contacts with families

BEHAVIORALEnhanced pediatric surveillance

In Massachusetts, behavioral screening is mandated at every pediatric visit, which for children in the target population (ages 3-12 years) is annually. With enhanced monitoring, Family Partners will screen children using validated instruments quarterly and communicate results to the child's care team

BEHAVIORALTechnology enhanced care coordination

Behavioral: technology enhanced care coordination FPs will also have access to Act.MD, a cloud-based care coordination and communication tool that offers the potential to improve communication with families, schools, and the primary care site through administration of online questions, videoconferencing, and common portals that can be used by parents and multiple providers (e.g., FP, pediatrician, teacher).

BEHAVIORAL:Individually-tailored visits

Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts

BEHAVIORALClinic-based visits and community visits

In clinic-based visits the Family Partner is restricted to working at the primary care clinic and communication is restricted to telephone, text, and clinic visits. However in conditions with clinic based and community visits, the Family Partners will be available to meet families in their home and community (as well as the clinic), and accompany families to community-based meetings at school or childcare.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Goal Completion6 monthsSuccessful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Time to Goal Completion18 monthsTime to goal completion obtained from the electronic health record including Family Partner's template documentation.

Secondary

MeasureTime frameDescription
Satisfaction With Hospital Care Questionnaire (SHCQ)6 monthsThe 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 monthsThe 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 monthsThe 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 monthsThe 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 monthsThe 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 monthsThe 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 monthsScores 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

ArmCount
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
Total312

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015
Overall StudyLost to Follow-up0102000000000010
Overall StudyWithdrawal by Subject0100100000000000

Baseline characteristics

CharacteristicGroup 2- CowGroup 1- GoatGroup 3- HorseGroup 4- PigGroup 5- SheepGroup 6- LlamaGroup 7- CatGroup 8- DogGroup 9- DonkeyGroup 10- BearGroup 11- TigerGroup 12- LionGroup 13- MonkeyGroup 14- ZebraGroup 15- ElephantGroup 16- GiraffeTotal
Age, Continuous7.0 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 Participants6 Participants2 Participants6 Participants4 Participants4 Participants6 Participants6 Participants4 Participants5 Participants5 Participants6 Participants7 Participants6 Participants6 Participants5 Participants85 Participants
Race/Ethnicity, Customized
Black/African Am
4 Participants2 Participants3 Participants3 Participants4 Participants3 Participants2 Participants2 Participants2 Participants5 Participants4 Participants3 Participants5 Participants3 Participants6 Participants3 Participants54 Participants
Race/Ethnicity, Customized
Hispanic
12 Participants8 Participants9 Participants9 Participants10 Participants7 Participants7 Participants8 Participants9 Participants9 Participants9 Participants8 Participants6 Participants8 Participants7 Participants8 Participants134 Participants
Race/Ethnicity, Customized
More than one race
1 Participants3 Participants1 Participants1 Participants0 Participants1 Participants1 Participants1 Participants2 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants14 Participants
Race/Ethnicity, Customized
Other
0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants2 Participants11 Participants
Race/Ethnicity, Customized
Unknown
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants3 Participants
Race/Ethnicity, Customized
White
0 Participants1 Participants1 Participants0 Participants2 Participants1 Participants2 Participants1 Participants1 Participants1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants11 Participants
Region of Enrollment
United States
24 participants20 participants18 participants19 participants21 participants17 participants19 participants20 participants19 participants21 participants20 participants19 participants19 participants18 participants19 participants19 participants312 participants
Sex/Gender, Customized
Female
7 Participants8 Participants6 Participants8 Participants6 Participants4 Participants3 Participants8 Participants9 Participants6 Participants11 Participants11 Participants11 Participants10 Participants7 Participants6 Participants121 Participants
Sex/Gender, Customized
Male
17 Participants12 Participants12 Participants11 Participants15 Participants12 Participants16 Participants12 Participants10 Participants14 Participants7 Participants8 Participants8 Participants8 Participants12 Participants13 Participants187 Participants
Sex/Gender, Customized
Refused to answer
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants4 Participants

Adverse events

Event typeEG000
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 / 200 / 240 / 180 / 190 / 210 / 170 / 190 / 200 / 190 / 210 / 200 / 190 / 190 / 180 / 190 / 19
other
Total, other adverse events
0 / 200 / 240 / 180 / 190 / 210 / 170 / 190 / 200 / 190 / 210 / 200 / 190 / 190 / 180 / 190 / 19
serious
Total, serious adverse events
0 / 200 / 240 / 180 / 190 / 210 / 170 / 190 / 200 / 190 / 210 / 200 / 190 / 190 / 180 / 190 / 19

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1- GoatGoal Completion9 Participants
Group 2- CowGoal Completion9 Participants
Group 3- HorseGoal Completion7 Participants
Group 4- PigGoal Completion9 Participants
Group 5- SheepGoal Completion7 Participants
Group 6- LlamaGoal Completion6 Participants
Group 7- CatGoal Completion2 Participants
Group 8- DogGoal Completion4 Participants
Group 9- DonkeyGoal Completion7 Participants
Group 10- BearGoal Completion4 Participants
Group 11- TigerGoal Completion6 Participants
Group 12- LionGoal Completion6 Participants
Group 13- MonkeyGoal Completion10 Participants
Group 14- ZebraGoal Completion3 Participants
Group 15- ElephantGoal Completion5 Participants
Group 16- GiraffeGoal Completion6 Participants
Primary

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.

ArmMeasureValue (MEDIAN)
Group 1- GoatTime to Goal Completion168 days
Group 2- CowTime to Goal Completion159.5 days
Group 3- HorseTime to Goal Completion179 days
Group 4- PigTime to Goal Completion177 days
Group 5- SheepTime to Goal Completion184 days
Group 6- LlamaTime to Goal Completion193 days
Group 7- CatTime to Goal Completion218.5 days
Group 8- DogTime to Goal Completion191 days
Group 9- DonkeyTime to Goal Completion179 days
Group 10- BearTime to Goal Completion182 days
Group 11- TigerTime to Goal Completion190 days
Group 12- LionTime to Goal Completion191 days
Group 13- MonkeyTime to Goal Completion173 days
Group 14- ZebraTime to Goal Completion268.5 days
Group 15- ElephantTime to Goal Completion190.5 days
Group 16- GiraffeTime to Goal Completion192.5 days
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.

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.

ArmMeasureValue (MEAN)Dispersion
Group 1- GoatChange in Family Resource Scale (FRS)0.0 score on a scaleStandard Deviation 0.6
Group 2- CowChange in Family Resource Scale (FRS)0.3 score on a scaleStandard Deviation 1.2
Group 3- HorseChange in Family Resource Scale (FRS)0.1 score on a scaleStandard Deviation 0.4
Group 4- PigChange in Family Resource Scale (FRS)0.1 score on a scaleStandard Deviation 0.7
Group 5- SheepChange in Family Resource Scale (FRS)0.1 score on a scaleStandard Deviation 9.7
Group 6- LlamaChange in Family Resource Scale (FRS)0.0 score on a scaleStandard Deviation 0.4
Group 7- CatChange in Family Resource Scale (FRS)0.1 score on a scaleStandard Deviation 0.7
Group 8- DogChange in Family Resource Scale (FRS)0.6 score on a scaleStandard Deviation 0.9
Group 9- DonkeyChange in Family Resource Scale (FRS)0.8 score on a scaleStandard Deviation 0.9
Group 10- BearChange in Family Resource Scale (FRS)0.2 score on a scaleStandard Deviation 0.6
Group 11- TigerChange in Family Resource Scale (FRS)0.1 score on a scaleStandard Deviation 0.5
Group 12- LionChange in Family Resource Scale (FRS)0.2 score on a scaleStandard Deviation 0.6
Group 13- MonkeyChange in Family Resource Scale (FRS)0.0 score on a scaleStandard Deviation 0.7
Group 14- ZebraChange in Family Resource Scale (FRS)0.0 score on a scaleStandard Deviation 0.4
Group 15- ElephantChange in Family Resource Scale (FRS)0.2 score on a scaleStandard Deviation 0.6
Group 16- GiraffeChange in Family Resource Scale (FRS)0.5 score on a scaleStandard Deviation 0.8
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.

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.

ArmMeasureValue (MEAN)Dispersion
Group 2- CowChange in Patient Health Questionnaire-2 (PHQ-2)0.2 score on a scaleStandard Deviation 1.6
Group 4- PigChange in Patient Health Questionnaire-2 (PHQ-2)-0.3 score on a scaleStandard Deviation 0.5
Group 6- LlamaChange in Patient Health Questionnaire-2 (PHQ-2)-1.1 score on a scaleStandard Deviation 2.3
Group 8- DogChange in Patient Health Questionnaire-2 (PHQ-2)-0.2 score on a scaleStandard Deviation 2.4
Group 10- BearChange in Patient Health Questionnaire-2 (PHQ-2)-0.5 score on a scaleStandard Deviation 2
Group 12- LionChange in Patient Health Questionnaire-2 (PHQ-2)-0.2 score on a scaleStandard Deviation 1.6
Group 14- ZebraChange in Patient Health Questionnaire-2 (PHQ-2)0.4 score on a scaleStandard Deviation 1.1
Group 16- GiraffeChange in Patient Health Questionnaire-2 (PHQ-2)0.9 score on a scaleStandard Deviation 2
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 2- CowChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk1 Participants
Group 2- CowChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk9 Participants
Group 2- CowChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk1 Participants
Group 4- PigChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk5 Participants
Group 4- PigChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk2 Participants
Group 4- PigChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk0 Participants
Group 6- LlamaChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk4 Participants
Group 6- LlamaChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk1 Participants
Group 6- LlamaChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk0 Participants
Group 8- DogChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk1 Participants
Group 8- DogChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk0 Participants
Group 8- DogChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk6 Participants
Group 10- BearChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk1 Participants
Group 10- BearChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk3 Participants
Group 10- BearChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk5 Participants
Group 12- LionChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk0 Participants
Group 12- LionChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk0 Participants
Group 12- LionChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk5 Participants
Group 14- ZebraChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk1 Participants
Group 14- ZebraChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk0 Participants
Group 14- ZebraChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk5 Participants
Group 16- GiraffeChange in Pediatric Symptom Checklist-17 (PSC-17)Increased risk1 Participants
Group 16- GiraffeChange in Pediatric Symptom Checklist-17 (PSC-17)Decreased risk2 Participants
Group 16- GiraffeChange in Pediatric Symptom Checklist-17 (PSC-17)No change in risk3 Participants
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.

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.

ArmMeasureValue (MEAN)Dispersion
Group 1- GoatChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-1.0 score on a scaleStandard Deviation 5
Group 2- CowChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)1.2 score on a scaleStandard Deviation 8.9
Group 3- HorseChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)5.1 score on a scaleStandard Deviation 5.9
Group 4- PigChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)0.5 score on a scaleStandard Deviation 5.3
Group 5- SheepChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)1.3 score on a scaleStandard Deviation 6.3
Group 6- LlamaChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)0.3 score on a scaleStandard Deviation 12.1
Group 7- CatChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-3.6 score on a scaleStandard Deviation 6.1
Group 8- DogChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-1.3 score on a scaleStandard Deviation 8.2
Group 9- DonkeyChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-4.5 score on a scaleStandard Deviation 7.9
Group 10- BearChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-0.2 score on a scaleStandard Deviation 9
Group 11- TigerChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-3.0 score on a scaleStandard Deviation 8
Group 12- LionChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)1.2 score on a scaleStandard Deviation 6.1
Group 13- MonkeyChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-0.5 score on a scaleStandard Deviation 8.1
Group 14- ZebraChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-2.3 score on a scaleStandard Deviation 8
Group 15- ElephantChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-1.1 score on a scaleStandard Deviation 6.5
Group 16- GiraffeChange in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)-2.2 score on a scaleStandard Deviation 9.8
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 2- CowChange in the Survey of Well-being of Young Children (SWYC)No change in risk3 Participants
Group 2- CowChange in the Survey of Well-being of Young Children (SWYC)Decreased risk0 Participants
Group 2- CowChange in the Survey of Well-being of Young Children (SWYC)Increased risk1 Participants
Group 4- PigChange in the Survey of Well-being of Young Children (SWYC)Increased risk1 Participants
Group 4- PigChange in the Survey of Well-being of Young Children (SWYC)No change in risk4 Participants
Group 4- PigChange in the Survey of Well-being of Young Children (SWYC)Decreased risk1 Participants
Group 6- LlamaChange in the Survey of Well-being of Young Children (SWYC)Increased risk0 Participants
Group 6- LlamaChange in the Survey of Well-being of Young Children (SWYC)No change in risk1 Participants
Group 6- LlamaChange in the Survey of Well-being of Young Children (SWYC)Decreased risk2 Participants
Group 8- DogChange in the Survey of Well-being of Young Children (SWYC)Decreased risk2 Participants
Group 8- DogChange in the Survey of Well-being of Young Children (SWYC)Increased risk0 Participants
Group 8- DogChange in the Survey of Well-being of Young Children (SWYC)No change in risk4 Participants
Group 10- BearChange in the Survey of Well-being of Young Children (SWYC)Decreased risk0 Participants
Group 10- BearChange in the Survey of Well-being of Young Children (SWYC)Increased risk0 Participants
Group 10- BearChange in the Survey of Well-being of Young Children (SWYC)No change in risk4 Participants
Group 12- LionChange in the Survey of Well-being of Young Children (SWYC)Decreased risk1 Participants
Group 12- LionChange in the Survey of Well-being of Young Children (SWYC)Increased risk1 Participants
Group 12- LionChange in the Survey of Well-being of Young Children (SWYC)No change in risk4 Participants
Group 14- ZebraChange in the Survey of Well-being of Young Children (SWYC)Decreased risk1 Participants
Group 14- ZebraChange in the Survey of Well-being of Young Children (SWYC)Increased risk0 Participants
Group 14- ZebraChange in the Survey of Well-being of Young Children (SWYC)No change in risk2 Participants
Group 16- GiraffeChange in the Survey of Well-being of Young Children (SWYC)Decreased risk1 Participants
Group 16- GiraffeChange in the Survey of Well-being of Young Children (SWYC)No change in risk3 Participants
Group 16- GiraffeChange in the Survey of Well-being of Young Children (SWYC)Increased risk1 Participants
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.

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.

ArmMeasureValue (MEAN)Dispersion
Group 1- GoatInterpersonal Relationship With Navigator (PSN-I)31.4 score on a scaleStandard Deviation 14.6
Group 2- CowInterpersonal Relationship With Navigator (PSN-I)35.9 score on a scaleStandard Deviation 11.1
Group 3- HorseInterpersonal Relationship With Navigator (PSN-I)30.6 score on a scaleStandard Deviation 12.3
Group 4- PigInterpersonal Relationship With Navigator (PSN-I)31.4 score on a scaleStandard Deviation 13.3
Group 5- SheepInterpersonal Relationship With Navigator (PSN-I)30.4 score on a scaleStandard Deviation 13.1
Group 6- LlamaInterpersonal Relationship With Navigator (PSN-I)33.4 score on a scaleStandard Deviation 13.3
Group 7- CatInterpersonal Relationship With Navigator (PSN-I)32.1 score on a scaleStandard Deviation 12.8
Group 8- DogInterpersonal Relationship With Navigator (PSN-I)30.4 score on a scaleStandard Deviation 10.8
Group 9- DonkeyInterpersonal Relationship With Navigator (PSN-I)30.5 score on a scaleStandard Deviation 13.4
Group 10- BearInterpersonal Relationship With Navigator (PSN-I)32.2 score on a scaleStandard Deviation 11.5
Group 11- TigerInterpersonal Relationship With Navigator (PSN-I)33.1 score on a scaleStandard Deviation 12.7
Group 12- LionInterpersonal Relationship With Navigator (PSN-I)26.7 score on a scaleStandard Deviation 12.9
Group 13- MonkeyInterpersonal Relationship With Navigator (PSN-I)32.9 score on a scaleStandard Deviation 10.6
Group 14- ZebraInterpersonal Relationship With Navigator (PSN-I)27.2 score on a scaleStandard Deviation 12.9
Group 15- ElephantInterpersonal Relationship With Navigator (PSN-I)34.3 score on a scaleStandard Deviation 10.7
Group 16- GiraffeInterpersonal Relationship With Navigator (PSN-I)26.5 score on a scaleStandard Deviation 11.4
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.

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.

ArmMeasureValue (MEAN)Dispersion
Group 1- GoatSatisfaction With Hospital Care Questionnaire (SHCQ)90.4 score on a scaleStandard Deviation 18.5
Group 2- CowSatisfaction With Hospital Care Questionnaire (SHCQ)91.6 score on a scaleStandard Deviation 15.5
Group 3- HorseSatisfaction With Hospital Care Questionnaire (SHCQ)91.9 score on a scaleStandard Deviation 12
Group 4- PigSatisfaction With Hospital Care Questionnaire (SHCQ)96.4 score on a scaleStandard Deviation 10.1
Group 5- SheepSatisfaction With Hospital Care Questionnaire (SHCQ)92.9 score on a scaleStandard Deviation 13.1
Group 6- LlamaSatisfaction With Hospital Care Questionnaire (SHCQ)89.3 score on a scaleStandard Deviation 18.8
Group 7- CatSatisfaction With Hospital Care Questionnaire (SHCQ)83.8 score on a scaleStandard Deviation 19
Group 8- DogSatisfaction With Hospital Care Questionnaire (SHCQ)92.5 score on a scaleStandard Deviation 17.4
Group 9- DonkeySatisfaction With Hospital Care Questionnaire (SHCQ)90.9 score on a scaleStandard Deviation 20.5
Group 10- BearSatisfaction With Hospital Care Questionnaire (SHCQ)83.6 score on a scaleStandard Deviation 25
Group 11- TigerSatisfaction With Hospital Care Questionnaire (SHCQ)86.8 score on a scaleStandard Deviation 21.2
Group 12- LionSatisfaction With Hospital Care Questionnaire (SHCQ)89.7 score on a scaleStandard Deviation 16.2
Group 13- MonkeySatisfaction With Hospital Care Questionnaire (SHCQ)83.4 score on a scaleStandard Deviation 17.2
Group 14- ZebraSatisfaction With Hospital Care Questionnaire (SHCQ)94.1 score on a scaleStandard Deviation 14.7
Group 15- ElephantSatisfaction With Hospital Care Questionnaire (SHCQ)87.5 score on a scaleStandard Deviation 22.9
Group 16- GiraffeSatisfaction With Hospital Care Questionnaire (SHCQ)87.3 score on a scaleStandard Deviation 24

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026