Remote Assessment and Intervention for Behavior Problems in Kids With TSC

NCT06311474 | Completed

• 2 other identifiers: W81XWH-22-1-0250TS210009
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Eyberg Child Behavior Inventory (ECBI)

  The ECBI is a norm-referenced caregiver report measure of disruptive behavior in children.

  Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up (delayed treatment group only)

Secondary Outcomes (7)

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

  Baseline, 6-month follow-up

• Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3)

  Baseline, 6-month follow-up

• Parenting Stress Index-4th Edition-Short Form (PSI-4-SF)

  Baseline, 6-month follow-up

• Dyadic Parent-Child Interaction Coding System (DPICS)

  Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up (delayed treatment group only)

• Therapy Attitude Index (TAI)

  6-month follow-up (immediate treatment), 12-month follow-up (delayed treatment)

Study Arms (2)

Waitlist Control

NO 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.

Immediate Treatment

EXPERIMENTAL

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.

Behavioral: Parent-Child Interaction Therapy (PCIT)

Interventions

Parent-Child Interaction Therapy (PCIT) BEHAVIORAL

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.

Immediate Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• For assessment visit:
• None
• For intervention study:
• Plan for epilepsy surgery during study period

Sponsors & Collaborators

• University of California, Los Angeles: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Tuberous Sclerosis; Mental Disorders

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Nicole McDonald, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by assessors who are blind to group status. Investigators will be kept blind to study outcomes until data collection for the primary outcome is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: The clinical trial portion of this study uses a waitlist control design with random assignment to group. Randomization is stratified by age (3-4 years old, 5-6 years old).

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: August 1, 2022
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)