The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods

Jonathan S. Comer; Donna B. Pincus; Molly C. Adrian; Gary McCreary; Leslie Miller; Tomas Munarriz; Kathleen Myers; Karen Xiomara Pierre-Louis; Rheanna Platt; Melissa K. Ripley; Andrea E. Spencer; Haniya Saleem Syeda; Margarita Alegría; Amelia Brandt; Carolina Costa; Lindsay Cooper; Stefany Coxe; Annie W. Dantowitz; Anthony Steven Dick; Alyssa M. Farley; Jami M. Furr; Alex E. Keller; Julia A. Lejeune; Lauren F. McLellan; Dana L. McMakin; Rachel A. Merson; Ricardo F. Muñoz; Ronald M. Rapee; Kendra L. Read; Sara Rivero-Conil; Bridget Poznanski; Michelin Jane Janvier; Hanan N. Salem; Philip Shumway; Jennifer Sikov; Michelle V. Porche; Lisa R. Fortuna

doi:10.1016/j.jaacop.2025.12.003

The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods

Jonathan S. Comer^*, Donna B. Pincus, Molly C. Adrian, Gary McCreary, Leslie Miller, Tomas Munarriz, Kathleen Myers, Karen Xiomara Pierre-Louis, Rheanna Platt, Melissa K. Ripley, Andrea E. Spencer, Haniya Saleem Syeda, Margarita Alegría, Amelia Brandt, Carolina Costa, Lindsay Cooper, Stefany Coxe, Annie W. Dantowitz, Anthony Steven Dick, Alyssa M. FarleyJami M. Furr, Alex E. Keller, Julia A. Lejeune, Lauren F. McLellan, Dana L. McMakin, Rachel A. Merson, Ricardo F. Muñoz, Ronald M. Rapee, Kendra L. Read, Sara Rivero-Conil, Bridget Poznanski, Michelin Jane Janvier, Hanan N. Salem, Philip Shumway, Jennifer Sikov, Michelle V. Porche, Lisa R. Fortuna

^*Corresponding author for this work

School of Psychological Sciences

Research output: Contribution to journal › Article

Abstract

Objective: Pediatric anxiety constitutes a serious public health concern. Cognitive-behavioral therapy (CBT) is a gold standard treatment, preferred by families over pharmacological options, but barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist involvement and differential technologies to overcome barriers, but little is known about their effectiveness in typical care settings, as well as in pediatric care. The Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps. Method: The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing therapist-led CBT (telehealth, office-based, or hybrid) with guided internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating anxiety in youth (7-18 years old) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric health care sites affiliated with major medical centers in 4 metropolitan regions. This article describes the study's rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation. Conclusions: Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision making and help tailor treatment selections for underserved youth with anxiety. Clinical trial registration information: Kids FACE FEARS Comparative Effectiveness Research; https://clinicaltrials.gov/study/NCT03707158

Original language	English
Pages (from-to)	373-398
Number of pages	26
Journal	JAACAP Open
Volume	4
Issue number	2
Early online date	24 Dec 2025
DOIs	https://doi.org/10.1016/j.jaacop.2025.12.003
Publication status	Published - Apr 2026

Bibliographical note

Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

anxiety
cognitive-behavioral therapy
guided iCBT
iCBT
telehealth

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Comer, J. S., Pincus, D. B., Adrian, M. C., McCreary, G., Miller, L., Munarriz, T., Myers, K., Pierre-Louis, K. X., Platt, R., Ripley, M. K., Spencer, A. E., Syeda, H. S., Alegría, M., Brandt, A., Costa, C., Cooper, L., Coxe, S., Dantowitz, A. W., Dick, A. S., ... Fortuna, L. R. (2026). The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods. JAACAP Open, 4(2), 373-398. https://doi.org/10.1016/j.jaacop.2025.12.003

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title = "The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods",

abstract = "Objective: Pediatric anxiety constitutes a serious public health concern. Cognitive-behavioral therapy (CBT) is a gold standard treatment, preferred by families over pharmacological options, but barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist involvement and differential technologies to overcome barriers, but little is known about their effectiveness in typical care settings, as well as in pediatric care. The Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps. Method: The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing therapist-led CBT (telehealth, office-based, or hybrid) with guided internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating anxiety in youth (7-18 years old) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric health care sites affiliated with major medical centers in 4 metropolitan regions. This article describes the study's rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation. Conclusions: Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision making and help tailor treatment selections for underserved youth with anxiety. Clinical trial registration information: Kids FACE FEARS Comparative Effectiveness Research; https://clinicaltrials.gov/study/NCT03707158",

keywords = "anxiety, cognitive-behavioral therapy, guided iCBT, iCBT, telehealth",

author = "Comer, \{Jonathan S.\} and Pincus, \{Donna B.\} and Adrian, \{Molly C.\} and Gary McCreary and Leslie Miller and Tomas Munarriz and Kathleen Myers and Pierre-Louis, \{Karen Xiomara\} and Rheanna Platt and Ripley, \{Melissa K.\} and Spencer, \{Andrea E.\} and Syeda, \{Haniya Saleem\} and Margarita Alegr{\'i}a and Amelia Brandt and Carolina Costa and Lindsay Cooper and Stefany Coxe and Dantowitz, \{Annie W.\} and Dick, \{Anthony Steven\} and Farley, \{Alyssa M.\} and Furr, \{Jami M.\} and Keller, \{Alex E.\} and Lejeune, \{Julia A.\} and McLellan, \{Lauren F.\} and McMakin, \{Dana L.\} and Merson, \{Rachel A.\} and Mu{\~n}oz, \{Ricardo F.\} and Rapee, \{Ronald M.\} and Read, \{Kendra L.\} and Sara Rivero-Conil and Bridget Poznanski and Janvier, \{Michelin Jane\} and Salem, \{Hanan N.\} and Philip Shumway and Jennifer Sikov and Porche, \{Michelle V.\} and Fortuna, \{Lisa R.\}",

note = "Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2026",

month = apr,

doi = "10.1016/j.jaacop.2025.12.003",

language = "English",

volume = "4",

pages = "373--398",

journal = "JAACAP Open",

issn = "2949-7329",

publisher = "Elsevier",

number = "2",

}

Comer, JS, Pincus, DB, Adrian, MC, McCreary, G, Miller, L, Munarriz, T, Myers, K, Pierre-Louis, KX, Platt, R, Ripley, MK, Spencer, AE, Syeda, HS, Alegría, M, Brandt, A, Costa, C, Cooper, L, Coxe, S, Dantowitz, AW, Dick, AS, Farley, AM, Furr, JM, Keller, AE, Lejeune, JA, McLellan, LF, McMakin, DL, Merson, RA, Muñoz, RF, Rapee, RM, Read, KL, Rivero-Conil, S, Poznanski, B, Janvier, MJ, Salem, HN, Shumway, P, Sikov, J, Porche, MV & Fortuna, LR 2026, 'The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods', JAACAP Open, vol. 4, no. 2, pp. 373-398. https://doi.org/10.1016/j.jaacop.2025.12.003

TY - JOUR

T1 - The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety

T2 - rationale and methods

AU - Comer, Jonathan S.

AU - Pincus, Donna B.

AU - Adrian, Molly C.

AU - McCreary, Gary

AU - Miller, Leslie

AU - Munarriz, Tomas

AU - Myers, Kathleen

AU - Pierre-Louis, Karen Xiomara

AU - Platt, Rheanna

AU - Ripley, Melissa K.

AU - Spencer, Andrea E.

AU - Syeda, Haniya Saleem

AU - Alegría, Margarita

AU - Brandt, Amelia

AU - Costa, Carolina

AU - Cooper, Lindsay

AU - Coxe, Stefany

AU - Dantowitz, Annie W.

AU - Dick, Anthony Steven

AU - Farley, Alyssa M.

AU - Furr, Jami M.

AU - Keller, Alex E.

AU - Lejeune, Julia A.

AU - McLellan, Lauren F.

AU - McMakin, Dana L.

AU - Merson, Rachel A.

AU - Muñoz, Ricardo F.

AU - Rapee, Ronald M.

AU - Read, Kendra L.

AU - Rivero-Conil, Sara

AU - Poznanski, Bridget

AU - Janvier, Michelin Jane

AU - Salem, Hanan N.

AU - Shumway, Philip

AU - Sikov, Jennifer

AU - Porche, Michelle V.

AU - Fortuna, Lisa R.

N1 - Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2026/4

Y1 - 2026/4

N2 - Objective: Pediatric anxiety constitutes a serious public health concern. Cognitive-behavioral therapy (CBT) is a gold standard treatment, preferred by families over pharmacological options, but barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist involvement and differential technologies to overcome barriers, but little is known about their effectiveness in typical care settings, as well as in pediatric care. The Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps. Method: The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing therapist-led CBT (telehealth, office-based, or hybrid) with guided internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating anxiety in youth (7-18 years old) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric health care sites affiliated with major medical centers in 4 metropolitan regions. This article describes the study's rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation. Conclusions: Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision making and help tailor treatment selections for underserved youth with anxiety. Clinical trial registration information: Kids FACE FEARS Comparative Effectiveness Research; https://clinicaltrials.gov/study/NCT03707158

AB - Objective: Pediatric anxiety constitutes a serious public health concern. Cognitive-behavioral therapy (CBT) is a gold standard treatment, preferred by families over pharmacological options, but barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist involvement and differential technologies to overcome barriers, but little is known about their effectiveness in typical care settings, as well as in pediatric care. The Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps. Method: The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing therapist-led CBT (telehealth, office-based, or hybrid) with guided internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating anxiety in youth (7-18 years old) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric health care sites affiliated with major medical centers in 4 metropolitan regions. This article describes the study's rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation. Conclusions: Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision making and help tailor treatment selections for underserved youth with anxiety. Clinical trial registration information: Kids FACE FEARS Comparative Effectiveness Research; https://clinicaltrials.gov/study/NCT03707158

KW - anxiety

KW - cognitive-behavioral therapy

KW - guided iCBT

KW - iCBT

KW - telehealth

UR - https://www.scopus.com/pages/publications/105030889956

U2 - 10.1016/j.jaacop.2025.12.003

DO - 10.1016/j.jaacop.2025.12.003

M3 - Article

C2 - 41938225

AN - SCOPUS:105030889956

SN - 2949-7329

VL - 4

SP - 373

EP - 398

JO - JAACAP Open

JF - JAACAP Open

IS - 2

ER -

The Kids FACE FEARS pragmatic randomized trial of therapist-led vs guided internet cognitive-behavioral therapy for pediatric anxiety: rationale and methods

Abstract

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Keywords

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