A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures
再训练和控制疗法 (ReACT) 的多中心可行性临床试验,这是一种针对儿童功能性癫痫发作的身心治疗方法
基本信息
- 批准号:10648379
- 负责人:
- 金额:$ 57.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-01 至 2026-07-31
- 项目状态:未结题
- 来源:
- 关键词:18 year oldAddressAdherenceAdolescenceAdultAftercareAlabamaAnxietyAwarenessBehavioralBenchmarkingChildChildhoodClinicClinicalClinical TreatmentClinical TrialsCodeCognitiveCognitive TherapyConsciousDataDiagnosisDimensionsE-learningElectroencephalographyEnrollmentEpilepsyEvidence based treatmentFamilyFamily memberFrequenciesFrightFunctional ImagingFutureGoalsHabitsHearingIndividualInterventionMeasuresMedicineMoodsParentsParticipantPatientsPediatric HospitalsPersonsPlacebosPreparationProviderPublishingQuestionnairesRandomizedRandomized, Controlled TrialsRecommendationReportingResearchSchoolsSeizuresSelective Serotonin Reuptake InhibitorSiteSupportive careSymptomsTechniquesTexasTimeTrainingTreatment Side EffectsUnconscious StateUniversitiesVideotapeWorkadaptive interventionarmbehavioral clinical trialclinically significantcollegecommon symptomdiarieseffective therapyefficacy trialemerging adultexperiencefollow up assessmentfollow-upimaging studyimprovedmedical schoolsmeetingsmind/bodymindfulnessmulti-site trialnervous system disordernovelpreventrecruitresponsestandard carestandard of caretargeted treatmenttreatment planningweb platformweb-based intervention
项目摘要
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.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Aaron D Fobian其他文献
Aaron D Fobian的其他文献
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{{ truncateString('Aaron D Fobian', 18)}}的其他基金
Retraining and Control Therapy (ReACT): Sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric psychogenic non-epileptic seizures (PNES)
再训练和控制疗法(ReACT):将控制感和灾难性症状预期作为儿童心因性非癫痫发作(PNES)认知行为治疗的目标
- 批准号:
10718263 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
Retraining and Control Therapy (ReACT): Sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric psychogenic non-epileptic seizures (PNES)
再训练和控制疗法(ReACT):将控制感和灾难性症状预期作为儿童心因性非癫痫发作(PNES)认知行为治疗的目标
- 批准号:
10449133 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
Retraining and Control Therapy (ReACT): Sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric psychogenic non-epileptic seizures (PNES)
再训练和控制疗法(ReACT):将控制感和灾难性症状预期作为儿童心因性非癫痫发作(PNES)认知行为治疗的目标
- 批准号:
10286107 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
10219566 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
10430425 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
9179841 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
9324259 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
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