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Completed

NCT Number: NCT06311474

Remote Assessment and Intervention for Behavior Problems in Kids With TSC

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.

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Key information

Conditions

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

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

The proposed study uses a telehealth approach to remotely assess and treat behavior problems in preschool-aged children with TSC. This study aims to 1) measure the prevalence and quality of externalizing behavior problems and their relation to family functioning in preschool-aged children with TSC; 2) examine the feasibility and acceptability of internet-based PCIT (I-PCIT) in children with TSC; 3) investigate the effects of I-PCIT on child and parent behavior in preschool-aged children with TSC and behavior problems; and 4) examine predictors of treatment response.

For Aim 1, 100 children with TSC ages 3-6 years old will be enrolled. Developmental abilities and behavior problems will be assessed using norm-referenced parent report measures and video recordings of parent-child interactions. The prevalence of behavior problems in young children with TSC and relation to family functioning will be assessed. A subset of the children from Aim 1 who exhibit elevated externalizing behavior will be recruited for the pilot intervention, with a target sample size of 32. Children will be randomized to an immediate treatment or waitlist control group. Assessments will be performed at baseline (using Aim 1 data), mid-point (3 months later), and post-treatment (6 months later). Families randomized to the waitlist group will have a brief, additional post-treatment assessment 12 months post-baseline). Sessions occur on a weekly basis for up to 20 weeks. Preliminary efficacy will be examined by comparing trajectories from baseline to post-treatment between the immediate treatment and waitlist control groups. Data on feasibility, acceptability, and predictors of treatment response will be studied across all intervention participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Eyberg Child Behavior Inventory (ECBI)

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

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

Secondary outcomes

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

    Time frame: Baseline, 6-month follow-up

    The BASC-3 is a norm-referenced caregiver report measure of broad behavior problems and adaptive skills in children.

  2. Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3)

    Time frame: Baseline, 6-month follow-up

    The Vineland-3 is a norm-referenced caregiver report measure of adaptive skills for infancy through adulthood. Communication, daily living, socialization, and motor skills are measured. The parent interview version is used for this study.

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

    Time frame: Baseline, 6-month follow-up

    The PSI-4-SF is a norm-referenced self-report measure of parenting-related stress.

  4. Dyadic Parent-Child Interaction Coding System (DPICS)

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

    The DPICS measures parent-child interactions across 3 situations: child led play, parent led play, and clean up. Language and behavior are coded according to the DPICS-IV coding system.

  5. Therapy Attitude Index (TAI)

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

    The TAI measures treatment acceptability in PCIT.

  6. Telehealth Usability Questionnaire (TUQ)

    Time frame: Baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)

    The TUQ measures comfort with the use of telehealth methods pre- and post-treatment.

  7. Aberrant Behavior Checklist (ABC)

    Time frame: Baseline, 6-month follow-up

    The ABC is a caregiver report questionnaire commonly used to measure problem behaviors and behavior change in children and adults with disabilities.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: RAINBOW

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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