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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
312
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.
DotHouse Health
Dorchester, Massachusetts, United States
Goal Completion
Successful behavioral health service goal completion obtained from the electronic health record including Family Partner's template documentation.
Time frame: 6 months
Time to Goal Completion
Time to goal completion obtained from the electronic health record including Family Partner's template documentation.
Time frame: 18 months
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
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.