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AnxietyMAPPNCT06104904

Managing Anxiety in Pediatric Primary Care (MAPP)

A study testing MAPP in people with Anxiety and Anxiety Disorders, run by UConn Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Anxiety Disorders
What is being tested?
MAPP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteUnited States
Study dates
20 Nov 2023to 20 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UConn Health

    West Hartford, Connecticut, 06119

Other trials in United States

About this study

Official title: Enhancing the Capacity of Pediatric Primary Care Providers: A Pilot Trial of Anxiety Action Plan

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.

Read the 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.

Being tested
MAPP
Keywords
Anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAPPBehavioural

    Behavioral intervention based on exposure therapy strategies.

Study groups in NCT06104904
Study groupRoleWhat they receive
Managing Anxiety in Pediatric Primary Care (MAPP)ExperimentalParticipants receive approximately 4 sessions of a primary care provider-delivered intervention for reducing youth anxiety symptoms based on exposure therapy.
Receives: Behavioral: MAPP
Enhanced Usual Care (EUC)Placebo comparatorParticipants receive a list of resources on how to reduce anxiety (e.g., videos, books, etc.).
Receives: Behavioral: MAPP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start20 Nov 2023
  3. Primary completion20 Apr 2026
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104904
Sponsor's protocol ID
23-111SO-2
Other IDs
R34MH129410-01
Acronym
MAPP
Status last verified
Aug 2026
First submitted
18 Oct 2023
Last updated
12 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: As per NIMH requirements.

Questions about this trial

What is this clinical trial studying?

A study testing MAPP in people with Anxiety and Anxiety Disorders, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression Improvement scale (time frame: Youth will be assessed at 2 months (post intervention) and 6 months after eligibility is established.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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