A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures

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 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.

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.

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).

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.

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

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.

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?".

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.

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.

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.

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

Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by the parent. Assessed at baseline visit and all 4 follow-up visits

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.

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

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.

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

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

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.

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.

Assesses executive function and self-regulation in children and teens. Completed by participant at baseline visit and at first 2 follow-up visits.

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.

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.

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.

Participant will complete this 23-item scale which measures uncertainty about their diagnosis. Assessed at baseline visit and at first 2 follow-up visits.

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.

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.

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.

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.

Assesses parent and participant's therapeutic relationship, mastery of skill and involvement in therapy session. Completed by therapist at each intervention visit.

Assesses parent and child's knowledge on FND. Completed by parent and child at baseline and at first 2 follow-up visits.

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.

Assesses the patient's improvement in FS/FND which is due to treatment intervention. Completed by therapist during the 12 therapy sessions.

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

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.