MAPP for Anxiety Disorders in Children

(MAPP Trial)

Overseen By Grace L Imondi, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: Suicidality, Psychosocial treatment, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

60 Participants Needed

What You Need to Know Before You Apply

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.

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 3 4 5}

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. ^{2 3 4 5 6}

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. ^{2 3 5 7 8}

Who Is on the Research Team?

Golda S Ginsburg, PhD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MAPP

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.

How Is the Trial Designed?

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.).

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Anxiety disorders are highly prevalent among children and adolescents, and without treatment, they can lead to long-term negative effects on mental health.

Both behavioral and pharmacological treatments for anxiety can be effectively provided in primary care settings, making pediatricians a crucial resource for families seeking help.

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]

The implementation of universal anxiety screening using the General Anxiety Disorder-7 tool in pediatric primary care significantly increased the identification and diagnosis rates of anxiety disorders among adolescents aged 12-18 years.

This quality improvement project demonstrated that routine screening during well-child visits is an effective strategy for recognizing anxiety in children, which is crucial given that only 59% of affected children typically receive treatment.

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]

Measurement-based care using patient-level rating scales is essential for effectively treating pediatric anxiety disorders, as it helps guide clinical decisions and monitor treatment responses.

It is important to gather anxiety assessments from both children and their parents due to low agreement between them, ensuring a comprehensive understanding of the child's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Cognitive behavioral therapy (CBT) is recommended as the first-line treatment for anxiety disorders in youth, with the option of starting psychopharmacological treatment for severely anxious patients to facilitate participation in CBT.

Selective serotonin reuptake inhibitors (SSRIs) are identified as the first-line medication for treating anxiety disorders, while tricyclic antidepressants and venlafaxine serve as second-line options, highlighting the importance of a comprehensive management plan that includes both medication and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Approximately 8% of children aged 6-18 in a Northern California primary care network were diagnosed with anxiety and/or depression, with a notable percentage also having ADHD as a comorbidity.

The most commonly prescribed medications for anxiety and depression were sertraline, fluoxetine, and citalopram, aligning with treatment guidelines, although the use of benzodiazepines was noted as a concern.

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]

A review of five randomized controlled trials involving 1186 pediatric patients with generalized anxiety disorder (GAD) found that selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) effectively reduce anxiety symptoms, with numbers needed to treat (NNT) ranging from 2.8 to 9.3, indicating a favorable efficacy profile.

The treatment-emergent adverse events (TEAEs) associated with SSRIs and SNRIs were generally mild and did not commonly lead to discontinuation, suggesting a good safety and tolerability profile for these medications in youth with GAD.

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]

The initial approach to managing anxiety in children involves distinguishing between temporary anxiety symptoms and chronic anxiety disorders, with reassurance and practical advice being effective for mild cases.

For suspected anxiety disorders, referral to a mental health professional is crucial for accurate diagnosis and comprehensive treatment, as medication currently plays a limited role in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Anxiety disorders are very common in children and adolescents, and they can lead to more serious mental health issues later in life, making early evaluation and management crucial.

Primary care providers have effective tools and evidence-based strategies for assessing and treating anxiety disorders in young patients, which can be tailored to different developmental stages from preschool to adolescence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

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]