Functional SeizuresNCT05819268
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
A study testing ReACT and CATCH-IT in people with Functional Seizures and Convulsion, Non-Epileptic, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Functional Seizures, Convulsion, Non-Epileptic
- What is being tested?
- ReACT and CATCH-IT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females ages 11-18
- Diagnosis of functional seizures
- Internet access for telehealth sessions and CATCH-IT
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Badhma Valaiyapathi, MBBS, MPH, 205-975-4205, drbadhma@uab.edu
About this study
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.
Read the 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.
- Conditions
- Functional Seizures, Convulsion, Non-Epileptic
- Being tested
- ReACT, CATCH-IT
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReACTBehavioural
Also called Retraining and Control Therapy
ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.
CATCH-ITBehavioural
Also called Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training
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.
| Study group | Role | What they receive |
|---|---|---|
| ReACT Intervention | Experimental | 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. Receives: Behavioral: ReACT |
| CATCH-IT Intervention | Active comparator | 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. Receives: Behavioral: CATCH-IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
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.
Measured: 18 months
Acceptability
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.
Measured: 18 months
Participant Retention
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.
Measured: 18 months
Secondary outcomes (32)
Participant Adherence
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).
Measured: 18 months
Treatment Fidelity
Fidelity will be stratified by site and therapist/coach, such that 20% of each therapist/coach's sessions will be randomly chosen for fidelity assessment. The ReACT Fidelity Rating Scale includes assessment of the therapists' correct use of the ReACT Treatment Determination Tool, therapeutic alliance and empathy with the patient and family, development of opposing responses and use of motivators to reinforce progress. Fidelity to CATCH-IT sessions will be measured by the CATCH-IT coach fidelity scale, which assesses conduct of the motivational interview, review of the CATCH-IT sessions, therapeutic alliance and empathy with the patient and family.
Measured: 18 months
Functional seizure frequency
FS Diaries will be completed in REDCap by parents and children to prospectively track FS frequency from 7 days prior to treatment through 12 months post treatment, including date, time, location, duration and nature of symptoms. Those in ReACT will report if they used their treatment plan for each FS and track each FS they prevented with the plan. They will retrospectively report FS for the 3 weeks prior to initial screening. Discrepancies in parent and adolescent report will be discussed and rectified to improve accuracy
Measured: 15 to 17 months
Sense of Agency scale
Sense of Control Scale is a single question which asks, "How much control do you believe you have over your FS?" at baseline and post follow-up visits. Scores range from 0-3 with a higher score indicating no control over functional seizures.
Measured: 5 to 7 months
Treatment Preference Questionnaire
Treatment Preference Questionnaire will be completed before randomization to assess to which treatment the participant and parent prefer to be randomized. This is a single question which asks the participant "Which treatment would they prefer to be randomized to?".
Measured: Baseline Visit
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) is a survey of health-related quality of life for children with epilepsy with higher scores indicating a poor quality of life. It is used in patients with FS by instructing them to consider their FS when asked about "seizures". Scores range from 0-100. This will be completed at baseline and at first 2 follow-up visits.
Measured: 5 to 7 months
Revised Helping Alliance Questionnaire- II
Revised Helping Alliance Questionnaire-II is a 19-item scale will assess the therapist, children and parents' perception of the therapeutic alliance at at first 2 follow-ups. Scores ranges from 19-114 with a higher score indicating better therapeutic alliance.
Measured: 5 to 7 months
The Credibility/Expectancy Questionnaire
The Credibility/Expectancy Questionnaire will be used to compare treatment expectancy between conditions. It measures how much the patient believes the therapy they are receiving will help to reduce their FS. This will be completed by parent and participant initially after being randomized, after the first session, fourth session, eighth session and at the follow-up visits.
Measured: 15 to 17 months
Children's Somatic Symptoms Inventory (CSSI-24)
General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit and all 4 follow-up visits
Measured: 15 to 17 months
Anxiety Sensitivity Index (ASI)
Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by the parent. Assessed at baseline visit and all 4 follow-up visits
Measured: 15 to 17 months
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
Measures symptom severity in children; higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Functional Disability Inventory (FDI)
Completed by child and parent to measure physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by participant and parent. Assessed at baseline visit and at first 2 follow-up visits
Measured: 5 to 7 months
The Impact on Family Scale
Assesses parental perceptions of the impact of a child's medical condition on the family; higher scores indicate greater financial burden on the family. Assessed at baseline visit and all 4 follow-up visits.
Measured: 15 to 17 months
The Revised Children's Anxiety and Depression Scale (RCADS)
Measures anxiety and depression symptoms in children; higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit and all 4 follow-up visits
Measured: 15 to 17 months
Childhood Anxiety Sensitivity Index (CASI)
Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Score ranges from 18-54. Completed by participant. Assessed at baseline visit and all 4 follow-up visits
Measured: 15 to 17 months
Healthcare Related Stigma Questionnaire
Measures stigma in patients and their parents related to their interaction with health care providers; higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit.
Measured: At Baseline visit
Dysfunctional Attitude Scale (DAS-9)
Participant will complete this 9-item self-report measure that aims to determine stable negative attitudes that people with depression hold about themselves, the world, and their future. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Behavior Rating Inventory of Executive Functioning (BRIEF)
Assesses executive function and self-regulation in children and teens. Completed by participant at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Beaver's Self-Report Family Inventory
This is a 36 item scale which assesses a family member's view of overall family competence. Completed by participant and parent. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
Measures an individual's belief in his/her ability to control health outcomes. Form C of MHLC scale will be completed by participant at baseline and all 4 follow-up visits. Form A of MHLC scale will be completed by parent at baseline visit and first 2 follow-up visits.
Measured: 15 to 17 months
Rosenberg Self-esteem scale
This is a 10-item scale measuring self esteem. Score ranges from 0-30 with low scores indicating low self-esteem. Completed by participant at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
Participant will complete this 23-item scale which measures uncertainty about their diagnosis. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Illness Cognitions Scale
Participant will complete this 17-item scale measuring the degree to which they align with the sick role. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Center for Epidemiological Studies Depression Scale (CES-D)
Parent will complete this 10-item self-report depression inventory. Score ranges from 0 to 30 with higher scores indicating increasing levels of depression. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Participant will complete this 20-item self-report depression inventory. Score ranges from 0 to 60 with higher scores indicating increasing levels of depression. Assessed at baseline visit and at first 2 follow-up visits.
Measured: 5 to 7 months
Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
This is a 32-item scale assessing parenting style for self and partner. Completed by parent at baseline visit and 7-day follow-up visit.
Measured: 5 months
Session Summary Sheet (SSS)
Assesses parent and participant's therapeutic relationship, mastery of skill and involvement in therapy session. Completed by therapist at each intervention visit.
Measured: 5 to 7 months
FND Knowledge Questionnaire
Assesses parent and child's knowledge on FND. Completed by parent and child at baseline and at first 2 follow-up visits.
Measured: 5 to 7 months
Other FND Symptoms Questionnaire
Assesses the intensity and frequency of FND symptoms other than FS. Completed by both child and parent at baseline and all 4 follow-up visits.
Measured: 15 to 17 months
Clinical Global Impression
Assesses the patient's improvement in FS/FND which is due to treatment intervention. Completed by therapist during the 12 therapy sessions.
Measured: 5 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Addresses the full range of suicidal thoughts and behaviors that suggest a person is at heightened risk of committing suicide. This includes previous suicide attempts, history of suicidal ideation and intent and last-minute aborted attempts due to a change of heart. Participants will complete the measure at baseline and at 7 days post and 2 months post follow-up visits
Measured: 5 to 7 months
Single Quality of Life Question
Single quality of life question asks "Please rate your/your child's overall quality of life (i.e. your overall social, physical and mental wellbeing)". Completed by parent and participant at baseline and all 4 follow-up visits.
Measured: 15 to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start18 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional SeizuresStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children with FS will be enrolled and randomized to either ReACT or CATCH-IT therapies
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Baylor College of Medicine, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Aaron Fobian, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819268
- Sponsor's protocol ID
- IRB-300010786
- Other IDs
- 1R01AT012101-01A1
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
- ClinicalTrials.gov ID
- NCT05819268
- Acronym / sponsor ID
- IRB-300010786
- Conditions
- Functional Seizures, Convulsion, Non-Epileptic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Yale University, Baylor College of Medicine, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Children with FS will be enrolled and randomized to either ReACT or CATCH-IT therapies
| Arm | Type | Receives |
|---|---|---|
| ReACT Intervention | Experimental | Behavioral: ReACTDuring 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. |
| CATCH-IT Intervention | Active comparator | Behavioral: CATCH-ITDuring 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males and females ages 11-18
- Diagnosis of functional seizures
- Internet access for telehealth sessions and CATCH-IT
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReACTAlso: Retraining and Control TherapyReACT includes 12 sessions with a therapist that will discuss a plan for managing FS. | Behavioural | ReACT Intervention |
| CATCH-ITAlso: Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal TrainingCATCH-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. | Behavioural | CATCH-IT Intervention |
Primary outcome
Feasibility of Recruitment
Time frame: 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
Time frame: 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
Time frame: 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.
32 secondary outcomes
Participant Adherence
Time frame: 18 months
Treatment Fidelity
Time frame: 18 months
Functional seizure frequency
Time frame: 15 to 17 months
Sense of Agency scale
Time frame: 5 to 7 months
Treatment Preference Questionnaire
Time frame: Baseline Visit
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Time frame: 5 to 7 months
Revised Helping Alliance Questionnaire- II
Time frame: 5 to 7 months
The Credibility/Expectancy Questionnaire
Time frame: 15 to 17 months
Children's Somatic Symptoms Inventory (CSSI-24)
Time frame: 15 to 17 months
Anxiety Sensitivity Index (ASI)
Time frame: 15 to 17 months
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
Time frame: 5 to 7 months
Functional Disability Inventory (FDI)
Time frame: 5 to 7 months
The Impact on Family Scale
Time frame: 15 to 17 months
The Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: 15 to 17 months
Childhood Anxiety Sensitivity Index (CASI)
Time frame: 15 to 17 months
Healthcare Related Stigma Questionnaire
Time frame: At Baseline visit
Dysfunctional Attitude Scale (DAS-9)
Time frame: 5 to 7 months
Behavior Rating Inventory of Executive Functioning (BRIEF)
Time frame: 5 to 7 months
Beaver's Self-Report Family Inventory
Time frame: 5 to 7 months
FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
Time frame: 15 to 17 months
Rosenberg Self-esteem scale
Time frame: 5 to 7 months
Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
Time frame: 5 to 7 months
Illness Cognitions Scale
Time frame: 5 to 7 months
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 5 to 7 months
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame: 5 to 7 months
Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
Time frame: 5 months
Session Summary Sheet (SSS)
Time frame: 5 to 7 months
FND Knowledge Questionnaire
Time frame: 5 to 7 months
Other FND Symptoms Questionnaire
Time frame: 15 to 17 months
Clinical Global Impression
Time frame: 5 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 5 to 7 months
Single Quality of Life Question
Time frame: 15 to 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Functional Neurological Symptom Disorder, Functional Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReACT and CATCH-IT in people with Functional Seizures and Convulsion, Non-Epileptic, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Fobian, PhD (205-934-2241, afobian@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.