A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
The purpose of this study is to assess the feasibility of conducting a future fully powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS will be randomized to 12 sessions of Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) at 3 sites: University of Alabama at Birmingham, Yale School of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital.
Feasibility of recruitment will be measured by the percentage of planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. Acceptability will be assessed using the Acceptability Questionnaire. Participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall. For treatment fidelity assessment, 20% of each therapist's sessions will be randomly chosen and assessed for fidelity. Patient adherence will be measured in two ways: 1) the percent of ReACT or CATCH-IT sessions completed at each site and overall and 2) for ReACT, the percent of times participants report using the treatment plan during FS episodes (measured by FS diary) and for CATCH-IT, the number of times parents and children spend using CATCH-IT each week (measured by the CATCH-IT platform). These data will be used to support a future fully-powered multi-site RCT assessing the efficacy of ReACT for pediatric FS.
详细描述
This study aims to conduct a multi-site pilot feasibility Randomized Controlled Trial (RCT) at the University of Alabama at Birmingham, Yale College of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital.
Participants with functional seizures (FS) will be screened for eligibility over a phone call and eligible participants will be invited for a baseline visit. Participants with FS and their parent/guardian will then complete a baseline visit and 2 follow-up visits via HIPAA-compliant Zoom, 1 in-person initial therapy session and 11 video telehealth follow-up therapy sessions via HIPAA-compliant Zoom.
During the initial baseline visit, participants and their family member/caregiver will complete several questionnaires assessing demographics, mood, relationships with friends and family, as well as past and current FS symptoms. Participants will receive a functional seizure diary to record all episodes during the course of the study. This visit will last about an hour and a half to 2 hours. They will then be randomized to 12 sessions of either Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) or Retraining and Control Therapy (ReACT). CATCH-IT involves the parent and child completing Cognitive Behavioral Therapy (CBT) modules on the web-based CATCH-IT platform, and they will meet with a CATCH-IT coach 12 times to discuss the modules and plan how to apply this to their life and their FS. ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS. The first session for each intervention will be in-person with the subsequent 11 sessions conducted via video telehealth. Individual study teams from the 3 participating sites will conduct the ReACT or CATCH-IT interventions at their respective sites. The first therapy session will last about 2 hours and the subsequent 11 telehealth sessions will last about an hour.
There will be 2 follow-up visits via HIPAA-compliant Zoom which will follow the same protocol as the baseline visit. The first follow-up visit will be one week after the 12th therapy session, and the second follow-up visit will be two months after the 12th therapy session. Both these sessions will last about an hour.
Participants will also have the opportunity to undergo the therapy to which they were not randomized to after completing the 2-month follow-up after 12th therapy session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The PI, statistician and data manger will be blinded to treatment.
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 11-18
- •Diagnosis of functional seizures
- •Internet access for telehealth sessions and CATCH-IT
排除标准
- •Comorbid epilepsy
- •Less than 4 functional seizures per month
- •Other paroxysmal nonepileptic events (e.g. hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
- •Participation in other therapy
- •Severe intellectual disability
- •Severe mental illness (active delusions/hallucinations)
研究组 & 干预措施
ReACT Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.
ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.
Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
干预措施: ReACT (Behavioral)
CATCH-IT Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.
CATCH-IT involves the parent and child completing CBT modules on the web-based CATCH-IT platform, and they will meet with a CATCH-IT coach 12 times to discuss the modules and plan how to apply this to their life and their FS.
Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
干预措施: CATCH-IT (Behavioral)
结局指标
主要结局
Feasibility of Recruitment
时间窗: 18 months
Feasibility of recruitment will be measured by the percentage of the planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. This includes any participant who completes informed consent/assent.
Acceptability
时间窗: 18 months
Acceptability will be assessed using the Acceptability Questionnaire. The Acceptability Questionnaire is based on a published theoretical framework for assessment of acceptability of healthcare interventions and assesses acceptability of being randomized to ReACT vs. CATCH-IT, acceptability of the treatment received and presence of treatment side effects associated with ReACT or CATCH-IT, including all side effects associated with mindfulness. For each reported side effect, the duration, tolerability, perceived unpleasantness, impact on functioning and acceptability based on treatment benefit will be obtained.
Participant Retention
时间窗: 18 months
With the goal of analyzing data from the subsequent efficacy trial with an intention-to-treat analysis, participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall.
次要结局
- Participant Adherence(18 months)
- Treatment Fidelity(18 months)
- Functional seizure frequency(15 to 17 months)
- Sense of Agency scale(5 to 7 months)
- LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire(5 to 7 months)
- Treatment Preference Questionnaire(Baseline Visit)
- Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)(5 to 7 months)
- Revised Helping Alliance Questionnaire- II(5 to 7 months)
- The Credibility/Expectancy Questionnaire(15 to 17 months)
- Children's Somatic Symptoms Inventory (CSSI-24)(15 to 17 months)
- Anxiety Sensitivity Index (ASI)(15 to 17 months)
- Functional Disability Inventory (FDI)(5 to 7 months)
- The Impact on Family Scale(15 to 17 months)
- The Revised Children's Anxiety and Depression Scale (RCADS)(15 to 17 months)
- Childhood Anxiety Sensitivity Index (CASI)(15 to 17 months)
- Behavior Rating Inventory of Executive Functioning (BRIEF)(5 to 7 months)
- Beaver's Self-Report Family Inventory(5 to 7 months)
- FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales(15 to 17 months)
- Healthcare Related Stigma Questionnaire(At Baseline visit)
- Dysfunctional Attitude Scale (DAS-9)(5 to 7 months)
- Rosenberg Self-esteem scale(5 to 7 months)
- Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)(5 to 7 months)
- Illness Cognitions Scale(5 to 7 months)
- Center for Epidemiological Studies Depression Scale (CES-D)(5 to 7 months)
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(5 to 7 months)
- Parenting Style and Dimensions Questionnaire (PSDQ Short Version)(5 months)
- Session Summary Sheet (SSS)(5 to 7 months)
- FND Knowledge Questionnaire(5 to 7 months)
- Other FND Symptoms Questionnaire(15 to 17 months)
- Clinical Global Impression(5 months)
- The Columbia Suicide Severity Rating Scale (C-SSRS)(5 to 7 months)
- Single Quality of Life Question(15 to 17 months)
研究者
Aaron Fobian
Associate Professor
University of Alabama at Birmingham