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Behavioral Therapy for Tuberous Sclerosis (RT Trial)

N/A

Recruiting

Led By Jamie Capal, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their caregiver must be fluent in English

Children ages 8-17 years inclusive with a documented clinical and/or genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and/or impulsivity) are eligible for inclusion.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered after completion of rt (week 22)

Awards & highlights

RT Trial Summary

This trial will test if a program called RT can help kids/teens with Tuberous Sclerosis Complex and TAND to better manage their emotions.

Who is the study for?

This trial is for children aged 8-17 with Tuberous Sclerosis Complex (TSC) showing emotional issues like tantrums or impulsivity. They need stable internet for remote sessions, speak English, and have an IQ over 65. Kids on steady medication without plans to start new therapies or drugs soon can join.Check my eligibility

What is being tested?

The study tests 'Regulating Together', a non-drug program delivered remotely to help manage emotional problems in kids with TSC. It's a group intervention aiming to improve behavior without using medications.See study design

What are the potential side effects?

Since this is a behavioral intervention and not a drug treatment, there are no typical medical side effects; however, participants may experience stress or discomfort from discussing personal issues in a group setting.

RT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak and understand English well enough to participate in treatment sessions.

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My child, aged 8-17, has TSC and shows signs of behavioral issues like tantrums or impulsivity.

RT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intensive phase (week 6-10) and generalization phase (week 12-22)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intensive phase (week 6-10) and generalization phase (week 12-22)

This trial's timeline: 3 weeks for screening, Varies for treatment, and intensive phase (week 6-10) and generalization phase (week 12-22) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in CP-CTI score from pre-treatment to post-treatment

Change in EDI-R Score from Control Phase to RT Intensive and RT Generalization Phases Combined

Prevalence of ED in TSC Cohort

RT Trial Design

2Treatment groups

Experimental Treatment

Group I: ParentsExperimental Treatment1 Intervention

In this 22-week almost completely remote study, following a 5-week control phase, parents will receive intensive treatment twice per week for 5 weeks followed by a one-time, 1-on-1 counseling session with an RT psychologist (week 11). Then, parents will use skill practice and application in the home environment for 10 weeks. Following this, a final interview is conducted (week 22).

Group II: ChildrenExperimental Treatment1 Intervention

In this 22-week almost completely remote study, following a 5-week control phase, children will receive intensive group treatment, twice a week for 5 weeks delivered remotely. During the children's sessions, they will use child structured videos, the PlayPosit curriculum and learning rewards. The following assessments will be completed by the parents, regarding their children, at each phase; EDI, ABC-2, FS, BRIEF-2, CRS, PSI-4SF and CGI-I. Following the completion of group treatment, there will be a one-time, 1-on-1 counseling session with an RT psychologist.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

865 Previous Clinical Trials

327,594 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,937 Total Patients Enrolled

Jamie Capal, MDPrincipal InvestigatorUniversity of North Carollina at Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must prospective participants in this clinical trial possess?

"This research study seeks participants with tuberous sclerosis complex between the ages of 8 and 17. Approximately 105 volunteers will be accepted to this clinical trial."

Answered by AI

Are geriatric patients admissible for this investigation?

"The age criteria for this medical trial is 8 to 17 years old. Clinicialtrials.gov lists 23 studies that are specifically designed for minors and 25 trials focusing on elderly populations."

Answered by AI

How many participants is this study recruiting?

"Affirmative, according to clinicaltrials.gov the examination was initially announced on November 1st 2023 and has since been refreshed as of October 23rd 2023. The experiment is looking for 105 participants from two distinct centres."

Answered by AI

Is this research project accepting participants at the present time?

"As indicated by the information provided on clinicaltrials.gov, this medical trial is currently open to participants. The study was first publicized on November 1st 2023 and its particulars were last modified October 23rd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regulating Together in Tuberous Sclerosis Complex

2023. "Regulating Together in Tuberous Sclerosis Complex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105736.