Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities

OTHER

Navigation

The intervention in this study is a model of navigation for families seeking services at the two mental health agencies collaborating on this study. Navigators will implement a model of navigation with caregivers focused on reducing logistical and attitudinal barriers to care.

Initiation of services by caregiver

Time frame: Up to 18 months

Investigators will calculate time elapsed between assignment to condition and first session of recommended services and solicit navigator and caregiver report

Attendance in services; navigator and caregiver report

Time frame: 18 months

Number of times attended services; endorsement of service engagement

Change from Baseline Measure of Perceived Homophily at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(McCroskey, Richmond, \& Daley, 1975).The Measure of Perceived Homophily is a 16-item, four-factor continuous measure of an individual's perceived similarity and dissimilarity of another individual. This measure will be used to determine how similar the caregiver perceives their navigator on the four dimensions. The four dimensions include: Attitude, Background, Value, and Appearance. Each dimension includes 4 items, which are rated from 1 to 7 (e.g., 1 = Doesn't think like me to 7 = Thinks like me). Cronbach's α ranges from .51 to .93 (McCroskey et al., 2006)

Change from Baseline Social Network Assessment of Boundary Spanning at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(Marsden, 2011). Caregivers will be asked two questions at each assessment time point to determine sources of influence on services recommended by providers: 1) "Has your provider recommended services or practices to help with your child's mental health or family needs?If yes, please name them" and for each service or practice named by the caregiver, 2) Did you talk with anyone besides your provider about the service or practice? If yes, please indicate who you talked to about this service or practice. These questions will allow us to assess whether navigators are serving as a boundary spanner. Specifically, at each time point, we will calculate the proportion of services or practices recommended by the provider that were also discussed with the navigator.

Change from Baseline Norbeck Social Support at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(NSSQ; Norbeck et al., 1983). The NSSQ examines multiple components of caregiver social support. The Total Network Support Subscale (3 items) is the sum of the total number of members (up to 24) parents identify in their support network, frequency of contact with each member (1= once a year or less to 5 = daily), and length of the relationship with each member on a 5 point-scale (1 = less than 6 months to 5 = more than 5 years). The Total Functional Support Subscale (6 items) measures the sum of perceived affective/emotional (n = 4 items) and instrumental/tangible support (n = 2 items; 0 = not at all to 4 = a great deal). In addition, the NSSQ will also be used to examine the extent to which navigators provided context-relevant social support to caregivers. Scores range from 0 (not named or named but no support) to 24 (maximum support).

Change from Baseline Parental Attitudes Toward Psychological Services at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(PATPSI; Turner, 2012). This scale is a 26-item scale that assesses parental attitudes toward outpatient mental health services across three domains: Help-seeking attitudes, help-seeking intentions, and mental health stigma. Items are rated from 0 (strongly disagree) to 5 (strongly agree). The PATPSI has demonstrated discriminant validity as well as adequate internal consistency (Cronbach's α ranging from .72 to .92) and test-retest reliability (Pearson r ranging from .66 to .82).

Change from Baseline Family Empowerment at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

Rodriguez et al., 201 The adapted version of the original FES was designed to assess empowerment for families whose children have emotional disabilities (Rodriguez et al., 011). It consists of 34 items and three subscales: Family Empowerment (the ability to manage day-to-day life of the family, 12 items), Service System Empowerment (the caregiver's sense of ability to interact with the services system to obtain needed services,12 items), and Community/Political Empowerment (the caregiver's sense of ability to advocate for improved services, 10 items). Each subscales' internal consistency is high with Cronbach's alpha coefficients ranging from .87 to .88. Test-retest reliability is also high, ranging from .77-.85 (Koren et al. 1992), with high alpha reliability for the adapted version (.94; Rodriguez et al., 2011).

Change from Baseline Vanderbilt Mental Health Self Efficacy at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(Bickmanet al., 1991) This measure consists of 25 items measuring parents' self-efficacy beliefs and behavior expectations about mental health treatment for their children on a 5-point scale (1=strongly agree, 5=strongly disagree). The questionnaire has been used with both normative and high-risk samples with high internal consistency (alpha=.93 for normative and high-risk samples; Godwin, 2004). Construct validity has been established, with higher scores related to more parent collaboration with providers, increased social support, and more mental health service knowledge (Bickmanet al., 1998).

Change from Baseline Barriers to Treatment Participation at 6,12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(BTPS; Kazdinet al. 1997). This measure is a 44-item scale that is administered via caregiver interview assessing barriers to participation in children's treatment. Items are rated from 1 (never a problem) to 5 (very often a problem), measuring four different areas: stressors or obstacles that compete with treatment, treatment demands, perceived relevance of treatment, and relationship with the therapist, with high internal consistency (Cronbach's α = .86; Nock \& Photos, 2006)

Change from Baseline PROMIS Global Health Scale at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(Broderick et al., 2013).This 10-item self-report scale was developed to evaluate individuals' perceptions of overall health status and its impact on quality of life (Hays et al., 2009). The scale produces two subscale scores: Physical Health (GPH) and Mental Health (GMH). Items are reported on a Likert scale of 1 to 5, with the exception of an overall pain scale, which is rated from 1 (No pain) to 10 (Worst pain). Each scale has high internal consistency (GMH: alpha=.86, GPH: alpha=.81), and high convergent validity with other measures of health-related quality of life (Hays et al, 2009).

Change from Baseline OHIO Scales at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(Ogles et al., 2001) The OHIO scales isa broad measure of functioning for youth age 5 to 18 years. It includes two subscales addressing (a) problem areas (α = .86) and (b) positive areasof functioning (α = .91). Each subscale contains 20 items. There is a parent report and a clinician report. We will utilize the Functioning subscale.

Change from Baseline Strength and Difficulties at 6, 12, and 18 months

Time frame: Baseline, 6 months, 12 months, 18 months

(SDQ, Goodman, 2001). Caregivers will complete the SDQ at baseline to derive three scores of child symptoms: symptom severity, externalizing difficulties, and internalizing difficulties. The SDQ is a 25-item screening tool for youth ages 3-17. The response scale has three anchors (0 = Not true, 1 = Somewhat true, and 2 = Certainly true). Internal consistency for the parent report total difficulties score is 0.8 and inter-rater agreement is 0.44 (Stone et al. 2010)

Demographics

Time frame: Baseline

Child age, gender, and ethnicity, as well as other demographics, will be reported by the caregiver via REDCap. Caregiver demographics will be collected by research assistants via REDCap.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.