V Robin Weersing - US grants

DESCRIPTION (provided by applicant): This application describes an interlocking, two-site collaborative R01 to test the effects of a brief cognitive behavioral therapy (BCBT) protocol for youths (age 8-15) presenting with anxiety and/or depression in primary care. Over a five year period, 210 youths (105 per site) will be randomly assigned to (a) BCBT delivered in primary care or (b) enhanced referral to specialty mental health care (SMHC). This application builds on a preliminary study (N=60), in which a pilot version of BCBT was well-accepted by families and clinicians and was more efficacious than referral to SMHC. We now propose to test BCBT against an enhanced SMHC referral model in a larger, more diverse sample to establish its utility as a community-based intervention. Outcomes will be assessed by independent evaluators blind to participant status at 16 and 32 weeks post- randomization (Aim 1). It is hypothesized that BCBT will be superior to enhanced SMHC referral in terms of overall clinical improvement (CGI-I <2) and change in anxiety (PARS) and depression (CDRS-R) symptoms. Response also will be evaluated on brief self-report measures (SCARED, MFQ), as future community care may need to rely more heavily on these types of assessments. In addition, individual trajectories of participants will be examined to understand predictors of treatment response (Aim 2). It is hypothesized that severity of depression symptoms (youth and/or parent) will predict poorer response across treatments but that the BCBT program will still outperform the enhanced SHMC referral model. The effects of ethnicity also will be explored and use of two sites will allow greater enrollment of Hispanic (San Diego) and African-American (Pittsburgh) families than could be achieved by either in isolation. Targeting depression and anxiety as a unified problem area is innovative and in line with calls for new approaches to conceptualizing comorbidity and treating near neighbor disorders. Availability of an effective BCBT program for internalizing youths is needed as service settings struggle with limited sessions and resources available to train clinicians in multiple protocols. The application is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparision condition (enhanced SMHC referral) relevant for future treatment dissemination. Primary care has become a de facto site of mental health care delivery, with the possibilities of easier access, earlier identification and treatment, and prevention of chronicity. In line with this focus, data will be collected on the cost-effectiveness of the program (Aim 3) in order to lay the groundwork for future investigations focused on issues of dissemination, implementation, and real world sustainability. Site-unique contributions include expertise in practice-based research (San Diego) and data coordination (Pittsburgh). San Diego will serve as the overall coordinating site for the project. PUBLIC HEALTH RELEVANCE: This study will test whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with depression and anxiety. Impact of the program on symptoms and cost-effectiveness will be measured. This will be the first study to assess if anxiety and depression can be treated with one, simple program, and results may help move effective treatments for these serious problems into community practice.

PROJECT SUMMARY / ABSTRACT Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. Informed in part by the investigators' prior work, the field is now poised to make significant advances toward reducing the rate of depression by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk children and in their affected parents. The rationale for this approach is based on (a) our conceptual model that integrates parenting processes, stressors (particularly those associated with parental depression), and children's self-regulatory skills in the face of stress, (b) strong evidence of the familial nature of depression, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. The proposed 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This dual prevention approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (12 weekly + 3 monthly sessions) or a written information control (WI) condition. Parents and children will be evaluated at pre-, mid-, and immediately post-intervention, and at 6-, 12-, 18-, and 24-months from baseline. This single integrated intervention aims to prevent depressive symptoms and episodes in both children and parents, reduce associated disorders, and improve functioning (Aim 1). We also will assess the cost-effectiveness (CE) of FDP relative to the WI control and benchmarked against the CE of landmark studies in child prevention and adult depression treatment (Aim 1). Additionally, we will examine mediators (e.g., parenting behaviors; parents' cognitions; children's coping) and evaluate bidirectional effects between child and parent processes and outcomes (Aim 2). Finally, we will explore moderators [e.g., parental depression severity (Aim 3)] of the intervention-outcome relation.

The proposed mixed-methods study will (a) test the effectiveness of brief behavioral therapy (STEP-UP) for youths with anxiety and/or depression recruited from primary care community health centers (CHCs), (b) evaluate a population-based method of implementation of STEP-UP, and (c) explore patient, provider, and clinic reactions to identify target mechanisms for successful and sustainable implementation. Anxiety and mood disorders in youth are prevalent and impairing, with a high current and lifetime comorbidity in part due to shared etiologic factors. Untreated, these disorders lead to sustained functional impairment and convey increased risk for recurrent disorder and suicidal behavior. Only 1 in 5 anxious and 2 in 5 depressed youth report any lifetime mental health use, the lowest treatment rates for any youth mental health condition. Further, there are notable disparities in care, with minority youths significantly less likely to receive services than non- Hispanic white (NHW) youths, despite experiencing similar or higher rates of disorder. Therefore, effective treatment of anxiety and depression is a critical public health priority, especially for traditionally underserved minority youths. STEP-UP is a streamlined behavioral intervention developed to efficiently treat anxiety and depression as a unified problem area by targeting avoidance behavior common to both disorders. The proposed study builds on a multi-site randomized trial demonstrating the effectiveness of STEP-UP, with especially strong effects for Hispanic youths. This application responds to RFA-MH-20-400 and focuses on implementing and testing this promising evidence-based practice in the OCHIN network of CHCs and federally qualified health centers which serves a diverse population of vulnerable families. STEP-UP has been adapted to a digital health framework with video visits to increase dissemination potential, scalability, and cost-effectiveness. We propose to conduct an innovative hybrid effectiveness-implementation study (type 1) testing digitally delivered STEP-UP compared to facilitated referral to traditional outpatient mental health services (treatment-as-usual, TAU). Youths (age 8-17, N = 250) will be identified and recruited at the population level through electronic health records (EHR) and direct clinician referral of new cases. Eligible youths will be randomized to (a) STEP-UP or (b) facilitated referral to TAU. Clinical outcomes will be assessed at Weeks 16 and 32 and process measures collected over the course of care. Qualitative interviews will occur with 20 youth-parent dyads, 35 CHC providers and staff, and 20 administrators sampled from enrolled clinics. Aims include testing the clinical effectiveness of STEP-UP and engagement of the intervention mechanism in the vulnerable CHC population of families (Aim 1), evaluating the impact of STEP-UP on equity in mental health outcomes for minority youths (Aim 2), estimating the implementation cost and incremental cost effectiveness of STEP-UP (Aim 3), and identifying target mechanisms for sustainable implementation of STEP- UP in CHCs using the Consolidated Framework for Implementation Research (Aim 4).