N/A
Completed N=312
Family Partner Navigation for Children
Health Behavior
Source: ClinicalTrials.gov NCT03569449 ↗
Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Goal Completion — 9; 9; 7; 9 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Goal Completion |
9; 9; 7; 9; 7; 6 | — |
| PRIMARY Time to Goal Completion |
168; 159.5; 179; 177; 184; 193 | — |
| SECONDARY Change in the Survey of Well-being of Young Children (SWYC) |
1; 1; 0; 0; 0; 1 | — |
| SECONDARY Change in Pediatric Symptom Checklist-17 (PSC-17) |
1; 0; 1; 1; 3; 0 | — |
| SECONDARY Satisfaction With Hospital Care Questionnaire (SHCQ) |
90.4; 91.6; 91.9; 96.4; 92.9; 89.3 | — |
| SECONDARY Interpersonal Relationship With Navigator (PSN-I) |
31.4; 35.9; 30.6; 31.4; 30.4; 33.4 | — |
| SECONDARY Change in Family Resource Scale (FRS) |
0.0; 0.3; 0.1; 0.1; 0.1; 0.0 | — |
| SECONDARY Change in Patient Health Questionnaire-2 (PHQ-2) |
0.2; -0.3; -1.1; -0.2; -0.5; -0.2 | — |
| SECONDARY Change in the Parental Attitudes Toward Psychological Services Inventory (PATPSI) |
-1.0; 1.2; 5.1; 0.5; 1.3; 0.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03569449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.