Remote assessment and treatment for behavior problems in young children with tuberous sclerosis
Assessment and Treatment of Behavior Problems in TSC at Preschool Age: A Telehealth Approach
This study is testing a remote therapy program to help preschoolers with tuberous sclerosis who have behavior problems and see how it affects their families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06311474 on ClinicalTrials.gov |
What this trial studies
The RAINBOW study focuses on understanding and addressing behavior problems in preschool-aged children with tuberous sclerosis complex (TSC) through a fully remote approach. It aims to enroll 100 children aged 3 to 6 years to assess the prevalence of behavioral challenges and their impact on family functioning. Eligible children experiencing behavior problems will participate in a pilot intervention using internet-based Parent-Child Interaction Therapy (I-PCIT), which is tailored for TSC families. Participants will be randomly assigned to receive the intervention immediately or after a 6-month delay, with assessments conducted at various points to evaluate treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 6 years with a clinical diagnosis of tuberous sclerosis who exhibit behavior problems.
Not a fit: Patients who are planning for epilepsy surgery during the study period or have significantly impaired communication skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies for parents to manage challenging behaviors in children with TSC, improving family dynamics and child outcomes.
How similar studies have performed: While the approach of using telehealth for behavioral interventions is gaining traction, this specific adaptation for TSC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Nicole McDonald, PhD — University of California, Los Angeles
- Study coordinator: Viviana Rodriguez
- Email: vivianarodriguez@mednet.ucla.edu
- Phone: 424-326-3118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.