- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105736
Regulating Together in Tuberous Sclerosis Complex (RT)
January 31, 2024 updated by: University of North Carolina, Chapel Hill
Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)
The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a non-pharmacological intervention that will utilize small group-based therapy with participants, followed by a separate caregiver session.
The clinical trial will consist of four phases; 1) single in person screening/baseline visit; 2) RT control phase which is a 5-week observational period (Week 1-5); 3) RT intensive phase which is a remote group treatment intervention twice per week over 5 weeks (Week 6-10); 4) RT individualization phase, which is an individualized consultation with the participant and caregiver (Week 11); and 5) the RT generalization phase which is a 10 week follow up period consisting of utilizing the learned skills at home.
At the end of the 10-week generalization phase, a semi-structured interview for thematic analysis will occur at the end of the study to capture facilitators and barriers to the intervention (Week 12-22).
Study Type
Interventional
Enrollment (Estimated)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jamie Capal, MD
- Phone Number: (919) 966-9343
- Email: jamie.capal@cidd.unc.edu
Study Locations
-
-
North Carolina
-
Carrboro, North Carolina, United States, 27510
- Recruiting
- University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
-
Contact:
- Jamie Capal
- Phone Number: 919-966-9343
- Email: jamie.capal@cidd.unc.edu
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center (CCHMC)
-
Contact:
- Darcy Krueger, MD
- Phone Number: 513-636-4222
- Email: Darcy.krueger@cchmc.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Additional inclusion/eligibility criteria include:
- Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a device or internet service is the sole barrier to eligibility/participation, interested individuals will be connected to a TSC Clinic social worker to link them to existing government and charity programs specifically addressing this disparity in underserved communities and households in need (e.g., the Affordable Connectivity Program).
- 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
- Child must have a minimum IQ>65 on the WASI-II at the screening/baseline visit).
Exclusion Criteria:
- Participants be on a stable medication regimen at least 4 weeks prior to enrollment
- Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social skills training) or behavior medication within 30 days prior to enrollment or at any point during the study. ----Participants with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic/session, having significant co-occurring neuropsychiatric illness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or having significant sensory impairment that would limit participation in intervention curriculum/materials (e.g., blindness or uncorrected hearing loss) also will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parents
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).
|
RT is small-group-based, intensive behavioral intervention session delivered twice weekly over a secure remote platform for 60-minutes over 5 weeks.
Each session is led by a psychologist trained and certified in RT.
Caregiver groups meet at the same frequency and duration but at different times.
Each session has a specific focus for teaching participants to identify emotions and incorporation of cognitive behavioral therapy (CBT) and mindfulness skills that are reinforced through repeated practice.
Each session will include a review, relaxation, new material didactic, activities to reinforce material, mindfulness, and homework.
|
Experimental: Children
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.
|
RT is small-group-based, intensive behavioral intervention session delivered twice weekly over a secure remote platform for 60-minutes over 5 weeks.
Each session is led by a psychologist trained and certified in RT.
Caregiver groups meet at the same frequency and duration but at different times.
Each session has a specific focus for teaching participants to identify emotions and incorporation of cognitive behavioral therapy (CBT) and mindfulness skills that are reinforced through repeated practice.
Each session will include a review, relaxation, new material didactic, activities to reinforce material, mindfulness, and homework.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of ED in TSC Cohort
Time Frame: Baseline
|
Prevalence of emotion dysregulation is highly prevalent in TSC patients who exhibit problematic behaviors.
The EDI-R score at the screening study visit will determine the EDI-R and determine the presence or absence of emotion dysregulation in the cohort.
|
Baseline
|
Change in EDI-R Score from Control Phase to RT Intensive and RT Generalization Phases Combined
Time Frame: Intensive Phase (Week 6-10) and Generalization Phase (Week 12-22)
|
EDI-R score will be compared from pre-treatment (control phase) to post-treatment (RT Intensive Phase and RT Generalization Phases combined).
EDI-R is a caregiver administered, emotion dysregulation inventory with construct, range, and directionality that includes questions that the rater is asked to answer based on behaviors that are observed to cause problems.
These questions include, but are not limited to, creating a dangerous situation, interference with daily activities, increasing the stress of those around the individual, and hurting relationships.
There are 13 questions on the EDI-R; they are rated at, not at all, mild, moderate, severe, and very severe.
|
Intensive Phase (Week 6-10) and Generalization Phase (Week 12-22)
|
Change in CP-CTI score from pre-treatment to post-treatment
Time Frame: Administered after completion of RT (Week 22)
|
The primary endpoint will be CP-CTI responses from caregivers upon completion of RT Generalization Phase using a thematic analysis.
This will identify obstacles to treatment access.
Scores will be compared pre-treatment to post-treatment.
CP-CTI is a staff administered, caregiver perspective clinical trial interview.
This will occur through a telephone call from the study team to the caregiver.
|
Administered after completion of RT (Week 22)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jamie Capal, MD, University of North Carollina at Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shaffer RC, Schmitt LM, Reisinger DL, Coffman M, Horn P, Goodwin MS, Mazefsky C, Randall S, Erickson C. Regulating Together: Emotion Dysregulation Group Treatment for ASD Youth and Their Caregivers. J Autism Dev Disord. 2023 May;53(5):1942-1962. doi: 10.1007/s10803-022-05461-x. Epub 2022 Feb 9.
- Shaffer RC, Wink LK, Ruberg J, Pittenger A, Adams R, Sorter M, Manning P, Erickson CA. Emotion Regulation Intensive Outpatient Programming: Development, Feasibility, and Acceptability. J Autism Dev Disord. 2019 Feb;49(2):495-508. doi: 10.1007/s10803-018-3727-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2023
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
October 23, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Malformations of Cortical Development, Group I
- Malformations of Cortical Development
- Nervous System Malformations
- Neurocutaneous Syndromes
- Hamartoma
- Neoplasms, Multiple Primary
- Behavioral Symptoms
- Tuberous Sclerosis
Other Study ID Numbers
- 23-0274
- HT9425-23-1-0344 (Other Grant/Funding Number: U.S. Department of Defense)
- CDMRP-TS220041 (Other Identifier: U.S. Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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