Family Partner Navigation for Children

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Behavioral: Usual care; Behavioral: Clinic-based visits; Behavioral: Standard pediatric surveillance; Behavioral: Structured, schedule-based visits; Behavioral: Enhanced pediatric surveillance; Behavioral: Technology enhanced care coordination; Behavioral: Clinic-based visits and community visits

• Registration Number: NCT03569449
• Lead Sponsor: Boston Medical 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 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 Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Study Start: 2019-06-24
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2- Cow	Clinic-based visits	Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
Group 2- Cow	Structured, schedule-based visits	Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
Group 2- Cow	Enhanced pediatric surveillance	Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
Group 1- Goat	Structured, schedule-based visits	Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
Group 2- Cow	Usual care	Clinic-based visit, usual care, enhanced pediatric surveillance, and structured visits
Group 3- Horse	Clinic-based visits	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
Group 6- Llama	Usual care	Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
Group 6- Llama	Clinic-based visits	Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
Group 8- Dog	Enhanced pediatric surveillance	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
Group 10- Bear	Structured, schedule-based visits	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
Group 1- Goat	Usual care	Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
Group 3- Horse	Standard pediatric surveillance	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
Group 1- Goat	Clinic-based visits	Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
Group 1- Goat	Standard pediatric surveillance	Clinic-based visit, usual care, standard pediatric surveillance, and structured visits
Group 3- Horse	Structured, schedule-based visits	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
Group 4- Pig	Clinic-based visits	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 5- Sheep	Usual care	Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
Group 7- Cat	Clinic-based visits	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
Group 8- Dog	Clinic-based visits	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
Group 4- Pig	Structured, schedule-based visits	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 4- Pig	Technology enhanced care coordination	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 5- Sheep	Standard pediatric surveillance	Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
Group 7- Cat	Standard pediatric surveillance	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
Group 8- Dog	Technology enhanced care coordination	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and individually-tailored visits
Group 9- Donkey	Structured, schedule-based visits	Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
Group 10- Bear	Clinic-based visits and community visits	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
Group 12- Lion	Enhanced pediatric surveillance	Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 12- Lion	Technology enhanced care coordination	Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 12- Lion	Clinic-based visits and community visits	Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 3- Horse	Technology enhanced care coordination	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and structured visits
Group 4- Pig	Enhanced pediatric surveillance	Clinic-based visit, technology-enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 5- Sheep	Clinic-based visits	Clinic-based visit, usual care, standard pediatric surveillance, and individually-tailored visits
Group 6- Llama	Enhanced pediatric surveillance	Clinic-based visit, usual care, enhanced pediatric surveillance, and individually-tailored visits
Group 7- Cat	Technology enhanced care coordination	Clinic-based visit, technology-enhanced care coordination, standard pediatric surveillance, and individually-tailored visits
Group 10- Bear	Usual care	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
Group 11- Tiger	Standard pediatric surveillance	Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
Group 11- Tiger	Structured, schedule-based visits	Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
Group 11- Tiger	Technology enhanced care coordination	Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
Group 9- Donkey	Usual care	Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
Group 9- Donkey	Standard pediatric surveillance	Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
Group 13- Monkey	Standard pediatric surveillance	Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
Group 14- Zebra	Usual care	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
Group 15- Elephant	Technology enhanced care coordination	Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
Group 15- Elephant	Clinic-based visits and community visits	Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
Group 16- Giraffe	Technology enhanced care coordination	Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
Group 9- Donkey	Clinic-based visits and community visits	Clinic and community visits, usual care coordination, standard pediatric surveillance, and structured visits
Group 10- Bear	Enhanced pediatric surveillance	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and structured visits
Group 14- Zebra	Clinic-based visits and community visits	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits
Group 11- Tiger	Clinic-based visits and community visits	Clinic and community visits, technology enhanced care coordination, standard pediatric surveillance, and structured visits
Group 12- Lion	Structured, schedule-based visits	Clinic and community visits, technology enhanced care coordination, enhanced pediatric surveillance, and structured visits
Group 13- Monkey	Clinic-based visits and community visits	Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
Group 15- Elephant	Standard pediatric surveillance	Clinic and community visits, technology-enhanced care, standard pediatric surveillance, and individually-tailored visits
Group 16- Giraffe	Enhanced pediatric surveillance	Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
Group 16- Giraffe	Clinic-based visits and community visits	Clinic and community visits, technology-enhanced care, enhanced pediatric surveillance, and individually-tailored visits
Group 13- Monkey	Usual care	Clinic and community visits, usual care coordination, standard pediatric surveillance, and individually-tailored visits
Group 14- Zebra	Enhanced pediatric surveillance	Clinic and community visits, usual care coordination, enhanced pediatric surveillance, and individually-tailored visits

Primary Outcome Measures

Name	Time	Method
Access to services [Yes/No]	90 days from randomization	1st encounter with behavioral health services within 90 days of randomization obtained from the electronic health record including Family Partner's template documentation
Change in Pediatric Symptom Checklist-17 (PSC-17)	baseline, 12 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 by adding together the score for each of the 17 items, 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.. PSC-17 is embedded in the Epic (electronic health record) as a self-scoring form.
Times to services	90 days from randomization	Time from randomization to 1st behavioral health service encounter obtained from the electronic health record including Family Partner's template documentation
Change in the Survey of Well-being of Young Children (SWYC)	baseline, 12 months	The SWYC screens for cognitive, motor, language, and social-emotional development among children up to 5½ years of age. Behavioral symptoms will be tracked using the SWYC's Preschool Pediatric Symptom Checklist (PPSC), is an 18-item questionnaire with possible scores for each item of:"0" for each "Not at All" response, "1" for each "Somewhat" response, and "2" for each "Very Much" response. The total score is summed, can range from 0 to 36, and A PPSC total score of 9 or greater indicates that a child is "at risk" and needs further evaluation

Secondary Outcome Measures

Name	Time	Method
Satisfaction with Hospital Care Questionnaire (SHCQ)	6 months	The SHCQ addresses aspects of care including information, patient autonomy, and emotional support.
Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI)	baseline, 12 months	The 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). Higher scores are more favorable.
Interpersonal Relationship with Navigator (PSN-I)	6 months	The PSN-I 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 and can range from 9 to 45; higher scores indicate higher satisfaction with their interpersonal relationship with the patient navigator.
Change in Patient Health Questionnaire-2 [PHQ-2}	baseline, 12 months	The PHQ-2 is a validated 2-question depression screening tool. PHQ-2 score ranges from 0-6 The authors of the measure identified a score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely.
Change in Family Resource Scale (FRS)	baseline, 12 months	The 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. It is a self-administered instrument with each item being rated on a five-point scale ranging from "not-at-all-adequate" to "almost-always-adequate". Higher scores are more favorable.

Trial Locations

Locations (1)

DotHouse Health; 🇺🇸 Dorchester, Massachusetts, United States