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?

This trial explores how primary care doctors can better assist children with anxiety. It tests a new approach where doctors use a brief intervention called the Anxiety Action Plan (AxAP) during regular check-ups. Children with noticeable anxiety symptoms who aren't receiving mental health treatment might be suitable candidates. The trial compares this new plan to usual care methods, such as videos and handouts, to determine which is more effective. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative methods for managing childhood anxiety.

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 prior data suggests that the Anxiety Action Plan (AxAP) is safe for children?

Research has shown that the Anxiety Action Plan (AxAP), the foundation of the MAPP program, has undergone testing. In one study, 11 pediatricians used this plan with 25 children, aged 6 to 18, who had high anxiety levels. The program appeared well-received, with no major reports of negative effects.

MAPP emphasizes exposure therapy, a method where children gradually face their fears in a safe and controlled environment. This approach has generally been safe for kids, with most handling the sessions well. Although this trial lacks a specific phase label, earlier studies suggest the program is safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for anxiety disorders in children, which often involve medications or traditional therapy sessions, the MAPP program is unique because it delivers exposure therapy directly in a primary care setting. This approach makes it more accessible and integrated into regular healthcare visits, potentially reducing barriers to treatment. Researchers are excited about MAPP because it offers a practical, scalable solution for managing anxiety, aiming to provide effective care without needing specialized mental health services.

What evidence suggests that the MAPP intervention could be effective for reducing anxiety in children?

Research shows that the Anxiety Action Plan (AxAP), a key component of the MAPP program, holds promise for reducing anxiety in children. In this trial, participants in the "Managing Anxiety in Pediatric Primary Care (MAPP)" arm will receive about four sessions of an intervention delivered by primary care providers, based on exposure therapy. Earlier studies found that pediatricians who used this short program were very satisfied, giving it an average rating of 4.82 out of 5. This program helps doctors, whom children might already visit, recognize and support anxious kids using methods like exposure therapy. This approach gently introduces children to anxiety-provoking situations in a safe way. Early results suggest these methods could effectively reduce anxiety symptoms in young patients. ^{1 2 3 5 6}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06104904?term=anxiety&aggFilters=status:not%20rec%20ava,ages:child,funderType:nih&viewType=Table&rank=5

Managing Anxiety in Pediatric Primary Care (MAPP) ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4938007/

A Brief Pediatrician-Delivered Intervention for Anxious Youth This manuscript presents data from a single group pre-post open trial of the Anxiety Action Plan (AxAP), a brief pediatrician-delivered intervention to reduce ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27403041/

A Brief Pediatrician-Delivered Intervention for Anxious Youth Results: Pediatricians' ratings of the AxAP training were positive (mean overall satisfaction was 4.82 on 5 point scale).

4. sciencedirect.com sciencedirect.com/science/article/pii/S0882596325000582

Treating anxiety in pediatric primary care: A case report Case study that emphasizes the approach to managing an adolescent with anxiety. ... Intended and unintended outcomes after FDA pediatric antidepressant ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06104904/managing-anxiety-in-pediatric-primary-care-mapp?mp=aafa&page=4&id=115&slug=panic-disorders

Managing Anxiety in Pediatric Primary Care (MAPP) The study aims to refine and assess the feasibility of the Anxiety Action Plan (AxAP), a brief intervention to reduce pediatric anxiety, ...

6. researchgate.net researchgate.net/publication/277977486_An_Open_Trial_of_the_Anxiety_Action_Plan_AxAP_A_Brief_Pediatrician-Delivered_Intervention_for_Anxious_Youth

A Brief Pediatrician-Delivered Intervention for Anxious Youth Methods: Eleven pediatricians conducted the intervention with 25 youth (mean age 11.16 years; range 6-18 years) with elevated levels of anxiety ...