MAPP for Anxiety Disorders in Children
(MAPP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byGolda S Ginsburg, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UConn Health
Disqualifiers: Suicidality, Psychosocial treatment, others
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to conduct a randomized controlled trial to enhance the capacity of pediatric primary care providers to assist their patients who struggle with anxiety.
The study aims to refine and assess the feasibility of the Anxiety Action Plan (AxAP), a brief intervention to reduce pediatric anxiety, delivered by primary care providers (PCPs) in community pediatric primary care clinics. The goal of the AxAP is to enhance the capacity of PCPs to identify and intervene with anxious youth, which will enhance access to care in general and especially in locations with few mental health specialists. PCPs participating in this study will attend a training, administer the intervention to enrolled youth assigned to the MAPP condition, participate in coaching sessions, and fill out study questionnaires. Families participating in this study will complete evaluations with the study team, receive the intervention from their PCP (if assigned to the MAPP condition), and fill out study questionnaires. Researchers will compare the MAPP intervention to Enhanced Usual Care (EUC; consisting of videos, handouts, and other resources for anxiety reduction) to see the differences, if any, in child outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving psychosocial mental health treatment for anxiety, you may not be eligible to participate.
What data supports the effectiveness of the treatment MAPP for anxiety disorders in children?
Research shows that both behavioral and medication treatments can be effective for anxiety in children when used in primary care settings. Cognitive behavioral therapy (a type of talk therapy) and certain medications are often recommended as first steps in treating anxiety in children.
12345Is the MAPP treatment for anxiety disorders in children safe?
The research articles do not provide specific safety data for the MAPP treatment or its other names, but they discuss the safety of psychopharmacologic interventions in general for pediatric anxiety disorders, suggesting that medications like SSRIs are considered safe as first-line treatments.
12467What makes the MAPP treatment unique for anxiety disorders in children?
MAPP (Managing Anxiety in Pediatric Primary Care) is unique because it focuses on integrating anxiety management directly within the primary care setting, allowing pediatricians to address anxiety symptoms early and provide reassurance and practical advice, which is different from traditional approaches that often require referral to mental health specialists.
12478Eligibility Criteria
This trial is for children aged 6-17 who show signs of anxiety, with scores indicating mild to moderate symptoms. It's designed to help pediatricians better support these kids, especially where mental health resources are scarce.Inclusion Criteria
Have elevated anxiety symptoms as indicated by a total Screen for Child Anxiety Rated Disorders score between 20 and 55 based on parent and/or child report
I am between 6 and 17 years old.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Training
Primary care providers attend a training session to learn the Anxiety Action Plan (AxAP) intervention
1 week
Treatment
Participants receive approximately 4 sessions of a primary care provider-delivered intervention for reducing youth anxiety symptoms based on exposure therapy
4-8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Participant Groups
The MAPP clinical trial is testing a brief intervention called the Anxiety Action Plan (AxAP), aimed at reducing anxiety in children. Pediatric care providers will be trained and compared using AxAP versus Enhanced Usual Care involving educational materials.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Managing Anxiety in Pediatric Primary Care (MAPP)Experimental Treatment1 Intervention
Participants receive approximately 4 sessions of a primary care provider-delivered intervention for reducing youth anxiety symptoms based on exposure therapy.
Group II: Enhanced Usual Care (EUC)Placebo Group1 Intervention
Participants receive a list of resources on how to reduce anxiety (e.g., videos, books, etc.).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UConn HealthWest Hartford, CT
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Who Is Running the Clinical Trial?
UConn HealthLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
National Institutes of Health (NIH)Collaborator
References
Treatment for Anxiety Disorders in the Pediatric Primary Care Setting. [2023]Anxiety disorders are among the most diagnosed mental health problems in children and adolescents. Without intervention, anxiety disorders in youth are chronic, debilitating, and amplify risk of negative sequelae. Youth with anxiety present to primary care frequently and often families choose to first discuss mental health concerns with their pediatricians. Both behavioral and pharmacologic interventions can be effectively implemented in primary care, and research demonstrates the effectiveness of both approaches.
Improving Mental Health Outcomes in Adolescent Patients With Universal Anxiety Screening in an Outpatient Pediatric Primary Care Office: A Quality Improvement Project. [2023]In the wake of the cultural and mental health consequences that arose since the COVID-19 pandemic, primary care providers must be able to assess and initiate treatment of anxiety disorders in the pediatric population. Only 59% of children with a diagnosable anxiety disorder are identified and receive treatment. This quality improvement project aimed to evaluate the implementation of universal anxiety screening using the General Anxiety Disorder-7 tool in pediatric primary care.
Measurement-Based Care in the Treatment of Anxiety. [2021]Treatment of pediatric anxiety disorders is complicated by their number, comorbidity, and the differential impact of a child's anxiety on the child and parents. Measurement-based care, using patient-level rating scales, can guide clinical decisions, track symptom improvement, and monitor treatment response. We review instruments for measurement-based care in pediatric anxiety. Measures used to track pediatric anxiety should be brief, accessible, sensitive to change, and reliable. Because parent-child agreement about a child's anxiety tends to be low, measures from both should be obtained. Measurements can also track functional improvement, expectancy related to treatment, and readiness to change.
Anxiety disorders in the child and teen. [2019]Several disorders have been reviewed (Table 1). Based upon review of the literature, an algorithm has been developed, supporting the initial use of cognitive behavioral therapy, followed by a psychopharmacology algorithm if treatment is not successful. In this algorithm, severely anxious patients initially may require psychopharmacologic treatment to be able to participate in cognitive behavioral treatment. Nonspecific measures of parent education, general support, and illness education to parents and patients are overarching principles. In this algorithm, the SSRIs are perceived to be first-line interventions, with tricyclic antidepressants and venlafaxine as second-line agents. Buspirone is considered a second- or third-line agent, as are the benzodiazepines. Table 2 reviews psychopharmacologic agents shown to be useful in the management of anxiety disorders in youth. Although much research remains to be done, there is evidence of efficacy of several interventions for anxiety disorders in children and adolescents. There is a need for a holistic and comprehensive management plan. Particular attention must be given to specific psychopharmacologic and psychotherapy needs, family matters, abuse issues, freedom from substance abuse, the use of peer support groups, and the encouragement of healthier lifestyle choices such as exercise. A rising number of well-done, large, placebo-controlled studies are providing increased support for medication and psychotherapy to inform evidence-based treatment. There is a need for teamwork and effective communication among team members in addressing pediatric and adolescent anxiety disorders.
Medication Management of Anxiety and Depression by Primary Care Pediatrics Providers: A Retrospective Electronic Health Record Study. [2022]To describe medication management of children diagnosed with anxiety and/or depression by primary care providers within a primary care network.
Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability. [2022]Randomized controlled trials consistently support the efficacy of antidepressants in treating youth with generalized anxiety disorder (GAD), although integrated examinations of efficacy, safety, and tolerability of psychotropic medications in GAD, specifically, are rare. With this in mind, we sought to describe the efficacy, safety, and tolerability of psychopharmacologic interventions in pediatric patients with GAD.
Pediatric management of anxiety disorders. [2019]The first step in the pediatric management of anxiety disorders is to determine whether a child or adolescent has acute, situational anxiety symptoms or a pervasive, chronic anxiety disorder. Such anxiety symptoms can most frequently be handled with reassurance and practical advice to the child and the parents, and followed by monitoring. However, if an anxiety disorder is suspected, then referral to a mental health professional is in order for confirmation of the diagnosis and institution of comprehensive treatment. Medication currently has a limited role in the treatment of any anxiety disorder, although psychopharmacologic treatment may become part of the overall care of obsessive-compulsive disorder in the future. Pediatricians may wish to learn more about behavioral-cognitive treatment approaches used by mental health professionals in the treatment of anxiety symptoms and disorders in children and adolescents. An excellent general text has been edited by R. Gittelman, Anxiety Disorders of Childhood.
Anxiety disorders in children and adolescents. [2022]Anxiety disorders are among the most common and functionally impairing mental health disorders to occur in childhood and adolescence. Primary care providers can expect to treat youth who have anxiety disorders frequently, and this article aims to provide the tools necessary to evaluate and manage patients who present with anxiety symptoms during childhood or adolescence. This article discusses the epidemiology of anxiety disorders, including the increased risk of future anxiety disorders and other mental health problems that are associated with having an anxiety disorder in childhood and adolescence. Next, the etiology of anxiety disorders is delineated, including discussion of genetic, cognitive-behavioral, physiological, and ecological explanatory models, and a summary of neurophysiological findings related to childhood and adolescent anxiety. Next, methods and tools are presented for assessment and treatment of anxiety disorders, with a focus on assessment and treatment that can be initiated in a primary care setting. Evidence-based therapy and medication interventions are reviewed. The article includes a focus on developmental differences in symptom presentation, assessment techniques, and treatment strategies, such that a primary care provider will have tools for working with the wide age range in their practices: preschool children through adolescents. We conclude that many effective intervention strategies exist, and their improving availability and ease of use makes it both critical and achievable for children and adolescents with anxiety disorders to be accurately diagnosed and treated with evidence-based medication and therapy.