Summary

Eligibility
for people ages 3-6 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Nicole McDonald, PhD (ucla)

Description

Summary

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.

Official Title

Assessment and Treatment of Behavior Problems in TSC at Preschool Age: A Telehealth Approach

Details

Keywords

Tuberous Sclerosis, TAND, TSC, Behavior Problems, PCIT, TSC-Associated Neuropsychiatric Disorders, Problem Behavior, Parent-Child Interaction Therapy (PCIT)

Eligibility

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Nicole McDonald, PhD (ucla)
    HS Assistant Clinical Professor, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 40 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06311474
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated