Managing Anxiety in Pediatric Primary Care (MAPP)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUConn Health

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Have a medical or psychiatric condition contraindicating participation (e.g., suicidality) based on clinical interview

Are receiving psychosocial mental health treatment for anxiety

PCPs must have a PA, RN, NP, APRN or MD degree and be at least a part time employee in a primary care setting. There are no other inclusion/exclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MAPP

    Behavioral

    Behavioral intervention based on exposure therapy strategies.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Managing Anxiety in Pediatric Primary Care (MAPP)Experimental treatment 1 intervention
Group B: Enhanced Usual Care (EUC)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

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

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UConn Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator