MAPP for Anxiety Disorders in Children

(MAPP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Golda S Ginsburg, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: UConn Health

Disqualifiers: Suicidality, Psychosocial treatment, others

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving psychosocial mental health treatment for anxiety, you may not be eligible to participate.

What data supports the effectiveness of the treatment MAPP for anxiety disorders in children?

Research shows that both behavioral and medication treatments can be effective for anxiety in children when used in primary care settings. Cognitive behavioral therapy (a type of talk therapy) and certain medications are often recommended as first steps in treating anxiety in children. ^{1 2 3 4 5}

Is the MAPP treatment for anxiety disorders in children safe?

The research articles do not provide specific safety data for the MAPP treatment or its other names, but they discuss the safety of psychopharmacologic interventions in general for pediatric anxiety disorders, suggesting that medications like SSRIs are considered safe as first-line treatments. ^{1 2 4 6 7}

What makes the MAPP treatment unique for anxiety disorders in children?

MAPP (Managing Anxiety in Pediatric Primary Care) is unique because it focuses on integrating anxiety management directly within the primary care setting, allowing pediatricians to address anxiety symptoms early and provide reassurance and practical advice, which is different from traditional approaches that often require referral to mental health specialists. ^{1 2 4 7 8}

Research Team

Golda S Ginsburg, PhD

Principal Investigator

UConn Health

Eligibility Criteria

This trial is for children aged 6-17 who show signs of anxiety, with scores indicating mild to moderate symptoms. It's designed to help pediatricians better support these kids, especially where mental health resources are scarce.

Inclusion Criteria

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

I am between 6 and 17 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Primary care providers attend a training session to learn the Anxiety Action Plan (AxAP) intervention

1 week

Treatment

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

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• MAPP (Behavioral Intervention)

Trial Overview The MAPP clinical trial is testing a brief intervention called the Anxiety Action Plan (AxAP), aimed at reducing anxiety in children. Pediatric care providers will be trained and compared using AxAP versus Enhanced Usual Care involving educational materials.

Participant Groups

Group I: Managing Anxiety in Pediatric Primary Care (MAPP) Experimental Treatment 1 Intervention

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

Group II: Enhanced Usual Care (EUC) Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UConn Health West Hartford, CT

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Patients Recruited

59,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3007

Patients Recruited

2,852,000+

National Institutes of Health (NIH)

Collaborator

Trials

2896

Patients Recruited

8,053,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for Anxiety Disorders in the Pediatric Primary Care Setting. Blossom, JB., Jungbluth, N., Dillon-Naftolin, E., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Mental Health Outcomes in Adolescent Patients With Universal Anxiety Screening in an Outpatient Pediatric Primary Care Office: A Quality Improvement Project. Kilkelly, TJ., Palmer, J., Kreashko, L.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement-Based Care in the Treatment of Anxiety. Romba, C., Lavigne, J., Walkup, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety disorders in the child and teen. Varley, CK., Smith, CJ.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Management of Anxiety and Depression by Primary Care Pediatrics Providers: A Retrospective Electronic Health Record Study. Lester, TR., Bannett, Y., Gardner, RM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability. Dobson, ET., Strawn, JR.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric management of anxiety disorders. Mattison, RE.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety disorders in children and adolescents. Rockhill, C., Kodish, I., DiBattisto, C., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment for Anxiety Disorders in the Pediatric Primary Care Setting. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Improving Mental Health Outcomes in Adolescent Patients With Universal Anxiety Screening in an Outpatient Pediatric Primary Care Office: A Quality Improvement Project. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Measurement-Based Care in the Treatment of Anxiety. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Anxiety disorders in the child and teen. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Medication Management of Anxiety and Depression by Primary Care Pediatrics Providers: A Retrospective Electronic Health Record Study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric management of anxiety disorders. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Anxiety disorders in children and adolescents. [2022]