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Behavioural Intervention

Immediate Treatment for Tuberous Sclerosis (RAINBOW Trial)

N/A

Recruiting

Led By Nicole McDonald, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)

Awards & highlights

RAINBOW Trial Summary

This trial aims to study behavior problems in young children with tuberous sclerosis complex (TSC). They will enroll 100 children between 3 and 6 years old to understand how to measure and

Who is the study for?

This trial is for children aged 3-6 with tuberous sclerosis complex (TSC), both with and without behavior problems. To participate, kids must have a diagnosis of TSC. The study aims to help those struggling with disruptive behaviors by using internet-based therapy tailored for TSC families.Check my eligibility

What is being tested?

The RAINBOW study tests an adapted version of Parent-Child Interaction Therapy (PCIT) delivered online to manage challenging behaviors in young children with TSC. Participants are randomly chosen to start treatment immediately or after a six-month wait, but all will receive the same therapy sessions weekly for up to 20 weeks.See study design

What are the potential side effects?

Since PCIT is a behavioral intervention involving parent-child interaction training rather than medication, there are no direct physical side effects like you'd expect from drugs. However, participants may experience stress or frustration as they adapt to new parenting techniques.

RAINBOW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eyberg Child Behavior Inventory (ECBI)

Secondary outcome measures

Aberrant Behavior Checklist (ABC)

Behavior Assessment Scale for Children-3rd Edition (BASC-3)

Dyadic Parent-Child Interaction Coding System (DPICS)

+4 more

RAINBOW Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate TreatmentExperimental Treatment1 Intervention

Participants randomized to the immediate treatment condition will receive written and verbal feedback after the baseline assessment visit. These families will begin PCIT shortly after this visit. These families will participate in follow-up visits at 3 and 6 months after the baseline visit.

Group II: Waitlist ControlActive Control1 Intervention

Participants randomized to the waitlist control (or delayed treatment) condition will receive written and verbal feedback after the baseline assessment visit. These families will participate in follow-up visits at 3 months, 6 months, and 12 months after the baseline visit. They will receive the same treatment (PCIT) after the 6-month assessment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parent-Child Interaction Therapy (PCIT)

2011

N/A

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,168 Total Patients Enrolled

4 Trials studying Tuberous Sclerosis

112 Patients Enrolled for Tuberous Sclerosis

Nicole McDonald, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical research study?

"Candidates aged between 3 and 6 years with a confirmed diagnosis of tuberous sclerosis are sought to fill the 100 available slots for this clinical trial."

Answered by AI

How many individuals in total will be participating in this medical study?

"Yes, data on clinicaltrials.gov indicates that this study is actively seeking volunteers. The trial was first listed on 8/1/2022 and the most recent update was made on 3/7/2024. Recruitment aims to enlist 100 participants at a single site."

Answered by AI

Are individuals older than 35 years eligible to enroll in this trial?

"Participants eligible for this study must fall within the 3 to 6 age range. There are a total of 61 trials available for individuals under 18 and an additional 65 studies catered towards those above the age of retirement."

Answered by AI

Is the process of enrolling participants still ongoing for this medical study?

"Indeed, information on clinicaltrials.gov affirms the ongoing patient recruitment for this trial. Initially shared on August 1st, 2022, and last modified on March 7th, 2024, this study aims to enroll a total of 100 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Assessment and Intervention for Behavior Problems in Kids With TSC

Nicole McDonald, PhD 2022. "Remote Assessment and Intervention for Behavior Problems in Kids With TSC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06311474.

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