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Anxiety disorders in youth are: 1) the most prevalent psychiatric disorders, 2) associated with severe disability, and 3) considered gateway disorders--as they predict a broad range of adult psychiatric and functional problems [1-6]. Despite the high prevalence and impairment, less than half of anxious youth receive mental health services, and access to evidenced-based interventions lags far behind that of less common psychiatric illnesses [7, 8]. For instance, in a primary care setting, only 31% of anxious youth, compared to almost 80% of youth with attention deficit hyperactivity disorder, received mental health treatment in the past year [8]. To address this ";mental health service gap,"; researchers [9-11] along with the Surgeon General [12] have recommended: 1) offering evidence-based mental health services in community settings frequented by children (i.e., to have co-located or integrated mental health services in primary care), 2) enhancing the capacity of existing community providers who interact with youth (e.g., primary care providers; PCPs), and 3) improving identification and early evidenced-based interventions in community settings to reduce the need for specialty mental health treatment. This proposal responds to these recommendations, as well as those by the American Academy of Pediatrics [13] to close the mental health service gap by enhancing the capacity of PCPs to deliver a brief mental health intervention in pediatric primary care. Primary care settings are ideal for addressing pediatric anxiety specifically because: 1) prevalence rates of excessive anxiety are high in primary care (approximately 10-20%) [6], 2) over 90% of anxious youth report physical complaints (e.g., stomach aches) and are ";frequent flyers"; in primary care settings [14, 15], 3) children with, compared to without, medical conditions treated by PCPs are more likely to have elevated anxiety [16], and 4) PCPs are often the first and only health professional children visit [17]. This three year R34 application also responds to NIH';s priorities in PAR-MH-21-131: Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34) aimed at testing interventions with previous efficacy in community settings using novel service delivery methods. Specifically, we propose to refine and assess the feasibility of the Anxiety Action Plan (AxAP), a brief intervention to reduce pediatric anxiety, delivered by PCPs (defined here as nurses, nurse practitioners, physician assistants, and/or pediatricians) in community pediatric primary care clinics. This proposal builds on the PI';s initial feasibility work with PCPs (see Preliminary Studies) [18] conducted as part of the NIMH-funded Center for Mental Health in Pediatric Primary Care. The AxAP, modeled after the Asthma Action Plan familiar to PCPs, is based on the core therapeutic element of CBT for anxiety (i.e., behavioral exposure) [19], was designed to fit within the short primary care visit (20-30 minutes), is brief (1-4 sessions), harnesses technology by using virtual training, assessment, and an option for virtual visits, and can be billed for as an office visit. Uniquely, and in stark contrast to co-location or integrated treatment models, the goal of the AxAP is to enhance the capacity of PCPs to identify and intervene with anxious youth. Importantly, enhancing the capacity of PCPs, rather than adding co-located mental health specialists, increases the reach of the intervention and the number of interventionists available and trained to identify and reduce anxiety, particularly in communities where access to specialty mental health specialists is limited. The proposal also incorporates several additional innovative features including: 1) the development and pilot testing of cost-benefit measures of the AxAP and 2) pilot testing of AxAP target mediators at the child, parent, and PCP levels. Primary Aims To refine and assess the feasibility of the AxAP and study methods (e.g., PCP training, adherence measures, control condition materials) during an open trial and with feedback from a development advisory team comprised of experts in the field. To conduct a pilot randomized controlled trial of AxAP, relative to Enhanced Usual Care, for reducing anxiety severity and impairment at post-intervention (2 months after randomization) and at a 4 month follow-up (6 months after randomization) with 6-12 PCPs and 60 anxious youth (ages 6-17). Secondary/Exploratory Aims To pilot measures for investigating theory-based intervention targets of AxAP including changes in: 1) PCP knowledge and skills in anxiety reduction strategies; 2) reductions in child behavioral avoidance and 3) reductions in parental accommodation of child anxiety. To refine and pilot measures to be used in a cost-benefit analysis of AxAP in a future large scale effectiveness trail (R01).
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