Clinical trial NCT05819268: A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
Official title: A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Seizures
Convulsion, Non-Epileptic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Yale University
name: Baylor College of Medicine
First posted: 2023-04-19
Enrollment: 108
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with FS will be enrolled and randomized to either ReACT or CATCH-IT therapies
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

There will be two long term follow-up visits via HIPAA-compliant Zoom, at 6 months after the final intervention session and at 12 months after the final intervention session where participants and parents will complete few questionnaires. Both these visits will last about 45 minutes.

Eligibility criteria: Inclusion Criteria:

* Males and females ages 11-18
* Diagnosis of functional seizures
* Internet access for telehealth sessions and CATCH-IT

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: 18 months
measure: Acceptability
timeFrame: 18 months
measure: Participant Retention
timeFrame: 18 months
Secondary outcomes:
measure: Participant Adherence
timeFrame: 18 months
measure: Treatment Fidelity
timeFrame: 18 months
measure: Functional seizure frequency
timeFrame: 15 to 17 months
measure: Sense of Agency scale
timeFrame: 5 to 7 months
measure: Treatment Preference Questionnaire
timeFrame: Baseline Visit
measure: Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
timeFrame: 5 to 7 months
measure: Revised Helping Alliance Questionnaire- II
timeFrame: 5 to 7 months
measure: The Credibility/Expectancy Questionnaire
timeFrame: 15 to 17 months
measure: Children's Somatic Symptoms Inventory (CSSI-24)
timeFrame: 15 to 17 months
measure: Anxiety Sensitivity Index (ASI)
timeFrame: 15 to 17 months
measure: LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
timeFrame: 5 to 7 months
measure: Functional Disability Inventory (FDI)
timeFrame: 5 to 7 months
measure: The Impact on Family Scale
timeFrame: 15 to 17 months
measure: The Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: 15 to 17 months
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: 15 to 17 months
measure: Healthcare Related Stigma Questionnaire
timeFrame: At Baseline visit
measure: Dysfunctional Attitude Scale (DAS-9)
timeFrame: 5 to 7 months
measure: Behavior Rating Inventory of Executive Functioning (BRIEF)
timeFrame: 5 to 7 months
measure: Beaver's Self-Report Family Inventory
timeFrame: 5 to 7 months
measure: FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
timeFrame: 15 to 17 months
measure: Rosenberg Self-esteem scale
timeFrame: 5 to 7 months
measure: Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
timeFrame: 5 to 7 months
measure: Illness Cognitions Scale
timeFrame: 5 to 7 months
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 5 to 7 months
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: 5 to 7 months
measure: Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
timeFrame: 5 months
measure: Session Summary Sheet (SSS)
timeFrame: 5 to 7 months
measure: FND Knowledge Questionnaire
timeFrame: 5 to 7 months
measure: Other FND Symptoms Questionnaire
timeFrame: 15 to 17 months
measure: Clinical Global Impression
timeFrame: 5 months
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 5 to 7 months
measure: Single Quality of Life Question
timeFrame: 15 to 17 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: