TSCRTNCT06105736
Regulating Together in Tuberous Sclerosis Complex
A study testing Behavioral Intervention in a small group platform in people with TSC and Behavioral Symptoms, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- TSC, Behavioral Symptoms
- What is being tested?
- Behavioral Intervention in a small group platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2023to 20 Dec 2026
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
- Recruiting
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Darcy Krueger, MD, 5136364222, Darcy.krueger@cchmc.org
About this study
Official title: 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).
Read the 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).
- Conditions
- TSC, Behavioral Symptoms
- Being tested
- Behavioral Intervention in a small group platform
- Medical subject headings
- Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention in a small group platformBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Experimental | 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). Receives: Behavioral: Behavioral Intervention in a small group platform |
| Children | Experimental | 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. Receives: Behavioral: Behavioral Intervention in a small group platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ED in TSC Cohort
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.
Measured: Baseline
Change in EDI-R Score from Control Phase to RT Intensive and RT Generalization Phases Combined
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.
Measured: Intensive Phase (Week 6-10) and Generalization Phase (Week 12-22)
Change in CP-CTI score from pre-treatment to post-treatment
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.
Measured: Administered after completion of RT (Week 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start20 Dec 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TSCStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Rochester
- Responsible party
- Principal investigator, Jamie Capal, Children's Hospital Medical Center, Cincinnati
- Investigators
- Jamie Capal, MD, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105736
- Sponsor's protocol ID
- 23-0274
- Other IDs
- HT9425-23-1-0344, CDMRP-TS220041
- Acronym
- RT
- Status last verified
- Dec 2025
- First submitted
- 23 Oct 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35141815Shaffer 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.
PubMed 30143951
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)
- ClinicalTrials.gov ID
- NCT06105736
- Acronym / sponsor ID
- RT / 23-0274
- Conditions
- TSC, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Rochester
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 30 Oct 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 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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | Experimental | Behavioral: Behavioral Intervention in a small group platformIn 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). |
| Children | Experimental | Behavioral: Behavioral Intervention in a small group platformIn 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- 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).
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Behavioral Intervention in a small group platformRT 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. | Behavioural | Children, Parents |
Primary outcome
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.
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.
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.
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 24 Dec 2025.
- Results publication: PubMed 35141815Shaffer 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.
- Results publication: PubMed 30143951Shaffer 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Jamie Capal, MD principal investigator
University of North Carollina at Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in a small group platform in people with TSC and Behavioral Symptoms, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 5 inclusion and 2 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jamie Capal, MD ((919) 966-9343, jamie.capal@cidd.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ED in TSC Cohort (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT06105736, which also lists 2 linked publications.
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 24 Dec 2025.