Managing Anxiety in Pediatric Primary Care (MAPP)

NCT06104904 | Recruiting

• 2 other identifiers: 23-111SO-2R34MH129410-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Anxiety Disorders

Keywords

Anxiety

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impression Improvement scale

  Improvement in anxiety symptoms and related functioning since baseline (a score of 1 or 2 is defined as a responder; scores of 3-7 are defined as non-responders).

  Youth will be assessed at 2 months (post intervention) and 6 months after eligibility is established.

• Primary Care Provider Primary outcome

  Satisfaction with MAPP: 70% of PCPs endorsing a score of 3 (somewhat helpful) or higher on a question asking "how helpful they perceived the program to be"; scores range from 0 (not at all helpful) to 4 very helpful.

  Post intervention (i.e., 2 months after first family enrolled)

Study Arms (2)

Managing Anxiety in Pediatric Primary Care (MAPP)

EXPERIMENTAL

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

Behavioral: MAPP

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

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

Behavioral: MAPP

Interventions

MAPP BEHAVIORAL

Behavioral intervention based on exposure therapy strategies.

Enhanced Usual Care (EUC); Managing Anxiety in Pediatric Primary Care (MAPP)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• UConn Health: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UConn Health

West Hartford, Connecticut, 06119, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Golda S Ginsburg, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Golda S Ginsburg, PhD

CONTACT

860-523-3788; gginsburg@uchc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: November 20, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of primary and secondary outcome results.
• Access Criteria: Researchers can request data from PI

Locations

US (1)