Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet.

Importance: Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment. Objective: To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD. Design, Setting, and Participants: This randomized clinical trial of 249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities. Data collection occurred from February 24, 2015, through November 5, 2018. Statistical analysis was performed on an intent-to-treat basis from November 5, 2018, to July 27, 2020. Interventions: Families were randomized to FN or conventional care management (CCM). Families receiving FN were assigned a navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services. Families receiving CCM were assigned to a care manager, who did limited telephone outreach. Families received FN or CCM after positive initial screening results and for 100 days after diagnostic ascertainment. Main Outcomes and Measures: The primary outcome, diagnostic ascertainment, was measured as the number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder was determined. Results: Among 250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White). Children who received FN had a greater likelihood of reaching diagnostic ascertainment over the course of 1 year (FN, 108 of 126 [85.7%]; CCM, 94 of 123 [76.4%]; unadjusted hazard ratio [HR], 1.39 [95% CI, 1.05-1.84]). Site (Boston, New Haven, and Philadelphia) and ethnicity (Hispanic vs non-Hispanic) moderated the effect of FN (treatment × site interaction; P = .03; Boston: HR, 2.07 [95% CI, 1.31-3.26]; New Haven: HR, 1.91 [95% CI, 0.94-3.89]; and Philadelphia: HR, 0.91 [95% CI, 0.60-1.37]) (treatment × ethnicity interaction; P < .001; Hispanic families: HR, 2.81 [95% CI, 2.23-3.54] vs non-Hispanic families: HR, 1.49 [95% CI, 1.45-1.53]). The magnitude of FN's effect was significantly greater among Hispanic families than among non-Hispanic families (diagnostic ascertainment among Hispanic families: FN, 90.9% [30 of 33], and CCM, 53.3% [16 of 30]; vs non-Hispanic families: FN, 89.7% [35 of 39], and CCM, 77.5% [31 of 40]). Conclusions and Relevance: Family navigation improved the likelihood of diagnostic ascertainment among children from racial/ethnic minority, low-income families who were detected as at risk for ASD in primary care. Results suggest differential effects of FN by site and ethnicity. Trial Registration: ClinicalTrials.gov Identifier: NCT02359084.

Developing a Problem-solving Intervention to Improve Self-Management and Transition Readiness in Adolescents with Sickle Cell Disease.

PURPOSE: Adolescents and young adults (AYA) with sickle cell disease (SCD) are at risk for serious complications including increased morbidity and early mortality during their transition from pediatric to adult care. Self-management support may help improve transition outcomes in this vulnerable population. Interventions based on teaching problem solving skills have been shown to improve adherence to therapy for AYA with other chronic disease and is a promising intervention in SCD. We sought patient and parent perspectives on improving self-management and input on the development of a problem-solving education (PSE) intervention. DESIGN AND METHODS: We held focus groups with AYA with SCD and caregivers to discuss barriers and facilitators of self-management, acceptability of PSE and intervention content and delivery. RESULTS: Five focus groups were held with AYA (n = 17) and caregivers (n = 15). Groups participated jointly to discuss self-management and then separately to discuss PSE. Data were analyzed using grounded theory and double-coded until thematic saturation was achieved. CONCLUSIONS: Both groups endorsed PSE as an acceptable intervention. Barriers to self-management included wanting to fit in with peers (AYA) and trouble letting go (parents); facilitators included having a regular routine (AYA) and sharing responsibility (parents). Participants suggested meeting in small groups for PSE sessions rather than individually and adding group sessions for parents. PRACTICAL IMPLICATIONS: Understanding AYA and caregivers' perceptions of barriers and facilitators of transition in SCD can help us better prepare AYA for transition. The specifics both groups identified as helpful will guide intervention development.

Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial.

Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343). Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, -12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.

Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start.

OBJECTIVE: The authors sought to determine whether a multicomponent, community-based program for preventing maternal depression also promotes engagement with mental health services for individuals with persistent symptoms. METHODS: Mothers of children enrolled in Head Start were randomly assigned between February 2011 and May 2016 to Problem-Solving Education (PSE) (N=111) or usual services (N=119) and assessed every two months for 12 months. RESULTS: Among 230 participants, 66% were Hispanic; 223 participants were included in the analysis. For all PSE participants, engagement with specialty mental health services increased from approximately 10% to 21% between two and 12 months. The PSE group was more likely than the control group to be engaged in specialty services at 12 months (adjusted odds ratio [AOR]=2.36, 95% confidence interval [CI]=1.07-5.20), and the rate of engagement with specialty services over time (treatment × time interaction) favored PSE (p=.016). Among PSE participants with persistent depressive symptoms over the follow-up period, engagement with specialty services increased from 12% (two months) to approximately 46% (12 months), whereas among control group participants, engagement fluctuated between 24% and 33%, without a clear trajectory pattern. At 12 months, PSE participants with persistent symptoms were more likely to engage with specialty care compared with their counterparts in the control group (AOR=6.95, CI=1.50-32.19). The treatment × time interaction was significant for the persistently symptomatic subgroup (p=.029) but not for the episodically symptomatic or the asymptomatic subgroups. CONCLUSIONS: Embedding mental health programs in Head Start is a promising strategy to engage parents with depressive symptoms in care, especially those with persistent symptoms.

Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial.

Importance: Although problem solving has been an important component of successful depression prevention and treatment interventions, evidence to support problem solving's mechanism of action is sparse. Objective: To understand the mechanism of an efficacious depression prevention intervention, problem-solving education (PSE). Design, Setting, and Participants: A multivariate path analysis was embedded within a randomized efficacy trial (February 15, 2011, to May 9, 2016). Participants were mothers with depressed mood, anhedonia, or depression history (but not in current major depressive episode) at 1 of 6 Head Start agencies. Participants were followed up for 12 months with serial assessments of potential intervention mediators and depressive symptoms. Interventions: Problem-solving education (n = 111) and usual Head Start services (n = 119). Main Outcomes and Measures: Primary outcomes were depressive symptom elevations, which were measured bimonthly. Eight plausible intervention mediators were assessed: problem-solving ability; mastery; self-esteem; perceived stress; behavioral activation; and avoidant, problem-focused, and social coping. Results: Among 230 participants, 152 (66.1%) were Hispanic; mean (SD) age was 31.4 (7.3) years. Based on associations with either PSE participation or depressive symptom outcomes, problem-solving ability, perceived stress, behavioral activation, and problem-focused coping were included in a parsimonious, multivariate path model. In this model, only perceived stress was associated with both PSE participation and depressive symptoms. Participants in the PSE group had adjusted standardized perceived stress change scores that were 11% lower than controls (95% CI, -0.19 to -0.03), and improvement in perceived stress generated an adjusted rate ratio (aRR) of 0.42 (95% CI, 0.33-0.53) for depressive symptom elevations. Participants in the intervention group also had standardized behavioral activation change scores 15% greater than controls (95% CI, 0.01-0.30) and problem-focused coping change scores 17% greater than controls (95% CI, 0.03-0.31); however, changes in these constructs were not associated with a differential rate of depressive symptom elevations. The direct effect of PSE on depressive symptom elevations (aRR, 0.72; 95% CI, 0.52-0.97) was greater than the mediated effect explained by improvement in perceived stress (aRR, 0.91; 95% CI, 0.85-0.98). Conclusions and Relevance: Problem-solving education is efficacious in preventing depressive symptoms and appears to work by decreasing perceived stress; however, the mechanism for much of PSE's impact on depression remains unexplained. These results can be used to simplify the intervention model in preparation for effectiveness testing. Trial Registration: ClinicalTrials.gov Identifier: NCT01298804.

Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial.

Importance: Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy. Objective: To determine the efficacy of a depression prevention strategy embedded in Head Start. Design, Setting, and Participants: This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016. Interventions: Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119). Main Outcomes and Measures: Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders. Results: Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants compared with 0.88 (1.37) among usual service participants (aIRR, 0.39; 95% CI, 0.21-0.75). However, no difference was observed among those with higher-level baseline symptoms (mean [SD] elevations, 2.06 [1.92] for PSE and 2.00 [1.91] for usual service; aIRR, 1.10; 95% CI, 0.67-1.80). Analysis of symptom scores followed the same pattern, with an adjusted mean reduction of 1.33 (95% CI, 0.36-2.29) among participants with lower-level baseline symptoms. Conclusions and Relevance: The PSE intervention is efficacious in preventing depressive symptom episodes and performs optimally among those with initial low-level symptoms. Additional effectiveness studies in Head Start are necessary to develop meaningful public health programs. Trial Registration: clinicaltrials.gov Identifier: NCT01298804.

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment.

We assessed dimensions of feasibility of a patient navigation system in the Head Start preschool setting to help low-income mothers with depression engage with mental health care. Forty-seven mothers participated; none refused. Navigators demonstrated excellent model fidelity; we experienced no adverse events. We discuss implications for future evaluation design.

Reducing Disparities in Timely Autism Diagnosis Through Family Navigation: Results From a Randomized Pilot Trial.

OBJECTIVE: Emerging evidence suggests that autism spectrum disorder (ASD) can be diagnosed by age 18 months and that early intensive behavioral intervention positively affects ASD core deficits. This pilot randomized controlled trial examined the feasibility of using an adapted form of patient navigation, Family Navigation (FN), to improve timely diagnosis of ASD in low-income families from racial-ethnic minority groups. METHODS: Forty children referred for an ASD diagnostic assessment were randomly allocated to receive FN or usual care. The primary outcome, time to diagnostic resolution, was assessed with survival analysis. RESULTS: Nineteen of 20 FN children completed the diagnostic assessment, compared with 11 of 19 children receiving usual care (hazard ratio=3.21, 95% confidence interval=1.47-6.98, p<.01). In regard to engagement of participants, 17 of 20 families (85%) met with the navigator for the targeted three in-person visits (median=4, range 1-9). CONCLUSIONS: FN may be a promising intervention to address barriers that impede timely ASD diagnosis.

Patient Navigation for Mothers with Depression who Have Children in Head Start: A Pilot Study.

This study assesses the potential of social work-facilitated patient navigation to help mothers with depression engage with mental health care. We conducted a randomized pilot trial (N = 47) in Head Start-a U.S. preschool program for low-income children. Seven lay navigators received training and supervision from professional social workers. After 6 months, more navigated participants engaged with a psychologist, therapist, or social worker (45% vs. 13%, 95% confidence interval [CI] [2, 57]); engaged with any provider, (55% vs. 26%, 95% CI [1, 56]); and reported having a "depression care provider" (80% vs. 41%, 95% CI [9, 65]). Community-based navigation appears feasible; however, more definitive testing is necessary.

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes.

Avoidance as an obstacle to preventing depression among urban women at high risk for violent trauma.

The impact of depression interventions is often attenuated in women who have experienced trauma. We explored whether psychological avoidance could explain this phenomenon. We synthesized two pilot randomized trials of problem-solving education (PSE) among a total of 93 urban mothers. Outcomes included depressive symptoms and perceived stress. Mothers with avoidant coping styles experienced an average 1.25 episodes of moderately severe depressive symptoms over 3 months of follow-up, compared to 0.40 episodes among those with non-avoidant coping (adjusted incident rate ratio [aIRR] 2.18; 95 % CI 1.06, 4.48). PSE tended to perform better among mothers with non-avoidant coping. Among mothers with non-avoidant coping, PSE mothers experienced an average 0.24 episodes, compared to 0.58 episodes among non-avoidant controls (aIRR 0.27; 95 % CI 0.05, 1.34). Among mothers with avoidant coping, PSE mothers experienced an average 1.26 episodes, compared to 1.20 episodes among avoidant controls (aIRR 0.76; 95 % CI 0.44, 1.33). This trend toward differential impact persisted when avoidance was measured as a problem-solving style and among traumatized mothers with and without avoidant PTSD symptoms. Further research is warranted to explore the hypothesis that psychological avoidance could explain why certain depression treatment and prevention strategies break down in the presence of trauma.

A qualitative study of parenting stress, coping, and discipline approaches among low-income traumatized mothers.

OBJECTIVE: The use of harsh discipline is a risk factor for child maltreatment and is more common among families in which mothers have previously experienced trauma. We sought to understand the stressors experienced by low-income traumatized mothers and the perceived impact of those stressors on their discipline approaches. METHODS: We conducted 30 in-depth qualitative interviews with low-income mothers with a history of trauma. We triangulated the results with experts in behavioral health, and with a subset of the informants themselves, to ensure data reliability. RESULTS: We identified the following themes: (1) Repetitive child behaviors are the most stressful. (2) Mothers commonly cope by taking time away; this can result in prolonged unsupervised periods for children. (3) Harsh discipline is used deliberately to prevent future behavior problems. (4) Mothers relate their children's negative behaviors to their own past experiences; in particular, those who have suffered domestic violence fear that their children will be violent adults. CONCLUSIONS: Our findings suggest that trauma-informed interventions to promote positive discipline and prevent child maltreatment should help mothers predict and plan for stressful parent-child interactions; identify supports that will allow them to cope with stress without leaving their children for prolonged periods; and explicitly address long-term goals for their children and the impact of different discipline approaches.

Adaptation of problem-solving treatment for prevention of depression among low-income, culturally diverse mothers.

Adapting evidence-based interventions to be more accessible and culturally sensitive to the needs of diverse populations is a potential strategy to address disparities in mental health care. We adapted an evidence-based depression-treatment strategy, Problem-Solving Treatment, to prevent depression among low-income mothers with vulnerable children. Intervention adaptations spanned 3 domains: (1) the intervention's new prevention focus, (2) conducting a parent-focused intervention in venues oriented to children; and (3) cultural competency. The feasibility of adaptations was assessed through 2 pilot-randomized trials (n = 93), which demonstrated high participant adherence, satisfaction, and retention, demonstrating the feasibility of our adaptations.

The role of sociocultural information in mental health intake sessions.

BACKGROUND: Clinicians are advised to provide culturally competent care but little is known about how this directive translates into clinical practice. we investigated how this directive was implemented by describing how clinicians utilize sociocultural (SC) information, and how it impacts the clinical encounter. METHOD: Data were collected in clinics in the Northeast of the U.S. Clients (N=129) and clinicians (N=47) participated in three components of the study: videotaping of the clinical intake, a qualitative interview, and reporting on sociodemographics. thematic analysis of interviews was conducted using NVivo7. RESULTS: Clinicians used sociocultural information to understand clients' clinical presentation; inform diagnosis; differentiate psychopathology from contextual circumstances that influence behavior; create empathy; and individuate clients. LIMITATIONS: Since the study only included data from public clinics, the results may not generalize to other settings. CONCLUSIONS: Integrating SC information appears critical to client engagement and to bonding between client and clinician, particularly for diverse populations utilizing public clinics.

Preferences for relational style with mental health clinicians: a qualitative comparison of African American, Latino and Non-Latino White patients.

The goal of this study is to analyze preferences for relational styles in encounters with mental health providers across racial and ethnic groups. Four primary themes describe what patients want from a mental health provider: listening, understanding, spending time, and managing differences. However, using contextual comparative analysis, the findings explicate how these themes are described differently across African Americans, Latinos, and non-Latino Whites, uncovering important qualitative differences in the meaning of these themes across the groups. The article suggests that closer attention to qualitative preferences for style of interaction with providers may help address disparities in mental health care for racial and ethnic minorities.