Managing Anxiety in Pediatric Primary Care (MAPP)

NCT ID: NCT06104904

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed Description

Anxiety disorders in youth are: 1) the most prevalent psychiatric illnesses, 2) associated with severe disability, and 3) considered gateway disorders--as they predict a broad range of adult psychiatric and functional problems. 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, such as attention deficit hyperactivity disorder. This application addresses this mental health service gap and 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, the investigators propose 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; defined here as nurse practitioners, physician assistants, and/or pediatricians) in community pediatric primary care clinics. 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%), 2) over 90% of anxious youth report physical complaints (e.g., stomach aches) and are "frequent flyers" in primary care settings, 3) children with, compared to without, medical conditions treated by PCPs are more likely to have elevated anxiety, and 4) PCPs are often the first and only health professional children visit. This study builds on the PI's development and feasibility pilot work with PCPs conducted as part of the NIMH-funded Center for Mental Health in Pediatric Primary Care and with school nurses as part of a Department of Education grant. The AxAP, modeled after the Asthma Action Plan familiar to PCPs, is based on the core element of cognitive behavioral therapy for anxiety (i.e., behavioral exposure), was designed to fit within the short primary care visit (20-30 minutes), can be delivered virtually, is brief (1-4 sessions), and can be billed for as an office visit. Uniquely, and in stark contrast to co-location or integrated models, 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. If results of this study are positive, findings would support a large effectiveness trial using an intervention that is ready for dissemination and that could significantly improve clinical care for anxious youth, enhance the capacity of PCPs to identify and reduce anxiety, and lower personal and economic costs associated with pediatric anxiety.

Conditions

Anxiety; Anxiety Disorders

Keywords

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Managing Anxiety in Pediatric Primary Care (MAPP)

Participants receive approximately 4 sessions of a primary care provider-delivered intervention for reducing youth anxiety symptoms based on exposure therapy.

Group Type: EXPERIMENTAL

MAPP

Intervention Type: BEHAVIORAL

Behavioral intervention based on exposure therapy strategies.

Enhanced Usual Care (EUC)

Participants receive a list of resources on how to reduce anxiety (e.g., videos, books, etc.).

Group Type: PLACEBO_COMPARATOR

MAPP

Intervention Type: BEHAVIORAL

Behavioral intervention based on exposure therapy strategies.

Interventions

MAPP

Behavioral intervention based on exposure therapy strategies.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 6-17 years of age
• 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

Exclusion Criteria

• Have a medical or psychiatric condition contraindicating participation (e.g., suicidality) based on clinical interview
• Are receiving psychosocial mental health treatment for anxiety

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Golda S. Ginsburg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Golda S Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

UConn Health

West Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Golda S Ginsburg, PhD

Role: CONTACT

Phone: 860-523-3788

Email: gginsburg@uchc.edu

Facility Contacts

Golda S Ginsburg, PhD

Role: primary

Grace L Imondi, BA

Role: backup

Other Identifiers

R34MH129410-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-111SO-2

Identifier Type: -

Identifier Source: org_study_id