protocolSection identificationModule nctId: NCT06311474, orgStudyIdInfo id: W81XWH-22-1-0250, briefTitle: Remote Assessment and Intervention for Behavior Problems in Kids With TSC, acronym: RAINBOW, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems., conditionsModule conditions: Tuberous Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The clinical trial portion of this study uses a waitlist control design with random assignment to group. Randomization is stratified by age (3-4 years old, 5-6 years old)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessments will be performed by assessors who are blind to group status. Investigators will be kept blind to study outcomes until data collection for the primary outcome is complete., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Parent-Child Interaction Therapy (PCIT), outcomesModule primaryOutcomes measure: Eyberg Child Behavior Inventory (ECBI), secondaryOutcomes measure: Behavior Assessment Scale for Children-3rd Edition (BASC-3), secondaryOutcomes measure: Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3), secondaryOutcomes measure: Parenting Stress Index-4th Edition-Short Form (PSI-4-SF), secondaryOutcomes measure: Dyadic Parent-Child Interaction Coding System (DPICS), secondaryOutcomes measure: Therapy Attitude Index (TAI), secondaryOutcomes measure: Telehealth Usability Questionnaire (TUQ), secondaryOutcomes measure: Aberrant Behavior Checklist (ABC), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California, Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Viviana Rodriguez, role: CONTACT, phone: 424-326-3118, email: vivianarodriguez@mednet.ucla.edu, contacts name: Nicole McDonald, role: CONTACT, phone: 310-825-3251, email: nmcdonald@mednet.ucla.edu, contacts name: Nicole McDonald, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False