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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
ReACT and CATCH-IT
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.

Aaron Fobian, PhD contact

205-934-2241

afobian@uabmc.edu

United States1 site, 1 recruiting
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Badhma Valaiyapathi, MBBS, MPH, 205-975-4205, drbadhma@uab.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT05819268
Study groupRoleWhat they receive
ReACT InterventionExperimentalDuring 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 InterventionActive comparatorDuring 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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.

  1. First posted19 Apr 2023
  2. Study start18 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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)
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

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.

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