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Not recruiting

Behavior Problems

Sponsor:

UCLA

Code:

NCT06311474

Conditions

Tuberous Sclerosis

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Interventions

Parent-Child Interaction Therapy (PCIT)

Study Details

Brief 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.

Conditions

Tuberous Sclerosis

Study ID

NCT06311474

Start date

Aug 1, 2022

Status verified date

Mar, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Waitlist Control

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.

experimental: Immediate Treatment

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.

Interventions

Parent-Child Interaction Therapy (PCIT)

PCIT is a dyadic therapy that focuses on enhancing the parent-child relationship and improving child behavior through positive parenting and limit setting skills. All PCIT sessions are delivered remotely via Zoom once per week for up to 20 weeks. Session length is about 1 hour. There are two distinct phases of PCIT, the Child Directed Interaction and the Parent Directed Interaction. Each phase begins with a Teach session, where parents learn about the skills they will practice during that portion of PCIT, and is followed by Coach sessions, in which the PCIT therapist provides direct feedback and live coaching on the use of the skills. An additional component is Daily Play practice. Parents are instructed to spend five minutes per day playing with their child, during which they practice skills learned during sessions. Adaptations have been made to the standard approach to increase suitability for the TSC population.

Primary outcome measure

  • Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up (delayed treatment group only) ]

Central Contacts and Locations

Central contacts

Viviana Rodriguez

424-326-3118vivianarodriguez@mednet.ucla.edu

Nicole McDonald, PhD

310-825-3251nmcdonald@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Viviana Rodriguez

424-326-3118vivianarodriguez@mednet.ucla.edu

Nicole McDonald

310-825-3251nmcdonald@mednet.ucla.edu

Principal Investigator:

Nicole McDonald, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • TAND
  • TSC
  • Behavior Problems
  • PCIT
  • TSC-Associated Neuropsychiatric Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2024-03-15.