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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Anxiety, Anxiety Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MAPP |
| Enhanced Usual Care (EUC) | Placebo comparator | Participants 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.
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.
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.
- First posted27 Oct 2023
- Study start20 Nov 2023
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Golda S. Ginsburg, UConn Health
- Investigators
- Golda S Ginsburg, PhD, Principal investigator, UConn Health
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Capacity of Pediatric Primary Care Providers: A Pilot Trial of Anxiety Action Plan
- ClinicalTrials.gov ID
- NCT06104904
- Acronym / sponsor ID
- MAPP / 23-111SO-2
- Conditions
- Anxiety, Anxiety Disorders
- Keywords
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managing Anxiety in Pediatric Primary Care (MAPP) | Experimental | Behavioral: MAPPParticipants receive approximately 4 sessions of a primary care provider-delivered intervention for reducing youth anxiety symptoms based on exposure therapy. |
| Enhanced Usual Care (EUC) | Placebo comparator | Behavioral: MAPPParticipants receive a list of resources on how to reduce anxiety (e.g., videos, books, etc.). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Have a medical or psychiatric condition contraindicating participation (e.g., suicidality) based on clinical interview
- Are receiving psychosocial mental health treatment for anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAPPBehavioral intervention based on exposure therapy strategies. | Behavioural | Enhanced Usual Care (EUC), Managing Anxiety in Pediatric Primary Care (MAPP) |
Primary outcome
Clinical Global Impression Improvement scale
Time frame: Youth will be assessed at 2 months (post intervention) and 6 months after eligibility is established.
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).
Primary Care Provider Primary outcome
Time frame: Post intervention (i.e., 2 months after first family enrolled)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. As per NIMH requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golda S Ginsburg, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
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.