Tuesday, December 30, 2025 12/30/2025

A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures

Award Number: R01AT012101
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures - Project Summary/Abstract Functional seizures (FS) are a type of functional neurological disorder (FND) characterized by seizure-like symptoms without EEG correlates. FS are severely debilitating to children and families, making this a significant clinical and societal burden. Recent research has revealed sense of control as a potential target for pediatric FS treatment. Our previously published study demonstrated children with FS have decreased sense of control over their actions compared to matched controls. Only one randomized controlled trial (RCT) for treatment of pediatric FS has been conducted to date, which evaluated Retraining and Control Therapy (ReACT). ReACT, developed by the PI, is a novel, adaptive intervention that aims to increase sense of control via mindfulness and principles of habit reversal, a well-established treatment for involuntary tics. Our recently published pilot RCT demonstrated that ReACT resulted in significantly reduced FS frequency compared to supportive therapy, with 82% of children remaining FS-free for ≥2 months after ReACT. Further, our preliminary data suggest sense of control significantly improves after ReACT, and increased sense of control after ReACT is significantly related to reduced FS frequency, indicating sense of control is an effective target for improving FS. The purpose of this study is to conduct a multi-site pilot feasibility clinical trial of ReACT, a mind and body treatment for pediatric FS. In the study, 54 11-18-year-olds diagnosed with FS will be randomized to engage in ReACT or the CATCH-IT web-based intervention (validated for treating mood in children) at three sites: the University of Alabama at Birmingham, the Yale School of Medicine/Yale New Haven Children’s Hospital and Baylor College of Medicine/Texas Children’s Hospital. FS frequency will be measured from 30 days before treatment to 2 months after treatment. Participants and a family member will complete baseline and follow-up assessments 7 days before treatment and 7 days and 2 months after treatment. Feasibility of recruitment and retention will be measured by meeting annual recruitment goals and the percent of participants who complete the 2-month follow-up. Sessions will be videotaped, and 20% of therapy sessions will be coded for treatment fidelity using published guides to assess intervention fidelity in behavioral clinical trials. Participant adherence to ReACT will be assessed by the percent of recommended treatment sessions completed, and participants and parents will report if the patient used the treatment plan for each FS episode using a FS diary.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	3	12/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $478,745 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	3	7/9/2025	NON-COMPETING CONTINUATION	$478,745
														Subtotal = $478,745

Issue Date FY: 2024 ( Subtotal = $530,376 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	001	2	7/17/2024	NON-COMPETING CONTINUATION	$530,376
2024	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	1	11/30/2023	NEW	$0
														Subtotal = $530,376

Issue Date FY: 2023 ( Subtotal = $574,500 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	1	8/1/2023	NEW	$574,500
														Subtotal = $574,500

Grand Total All Awards = $1,583,621

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A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures

Award Number: R01AT012101

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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