Remote Assessment and Intervention for Behavior Problems in Kids With TSC
Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Mar 7, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The RAINBOW study is a research project that aims to understand and help manage behavior problems in young children with tuberous sclerosis complex (TSC), a condition that can affect the brain and other organs. The study will include 100 children aged 3 to 6 years, both those who have behavior challenges and those who do not. Families will receive feedback about their child's behavior through assessments. Children who do show behavior problems may also be invited to participate in a special online therapy called Parent-Child Interaction Therapy (PCIT), which teaches parents skills to better handle their child's difficult behaviors. This therapy will be adjusted specifically for the needs of children with TSC.
To be eligible for the study, children must have a clinical diagnosis of TSC and be between 3 and 6 years old. Families should speak English or Spanish at home. If a child has significant behavior issues and their parent or caregiver is willing to participate in the therapy, they may be invited to join the intervention. Participants can expect weekly therapy sessions for up to 20 weeks, with follow-up assessments to see how things are going. This study will help researchers learn more about the common behavior problems in preschool-age children with TSC and how to better support families facing these challenges.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- For assessment visit:
- • Clinical diagnosis of TSC
- • Chronological age of 3 years, 0 months to 6 years, 11 months old at enrollment.
- • English or Spanish as primary language in the home.
- For intervention study only:
- • Elevated behavior problems
- • Parent/caregiver available to participate in PCIT
- Exclusion Criteria:
- For assessment visit:
- • None
- For intervention study:
- • Plan for epilepsy surgery during study period
- • Receptive communication skills below 18-month level
About University Of California, Los Angeles
The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Nicole McDonald, PhD
Principal Investigator
University of California, Los Angeles
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported