Tuberous SclerosisRAINBOWNCT06311474
Remote Assessment and Intervention for Behavior Problems in Kids With TSC
A study testing Parent-Child Interaction Therapy (PCIT) in people with Tuberous Sclerosis, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Tuberous Sclerosis
- What is being tested?
- Parent-Child Interaction Therapy (PCIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- For assessment visit:
- None
- For intervention study:
- Plan for epilepsy surgery during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Assessment and Treatment of Behavior Problems in TSC at Preschool Age: A Telehealth Approach
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.
Read the detailed description
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.
- Conditions
- Tuberous Sclerosis
- Being tested
- Parent-Child Interaction Therapy (PCIT)
- Keywords
- TAND, TSC, Behavior Problems, PCIT, TSC-Associated Neuropsychiatric Disorders
- Medical subject headings
- Tuberous Sclerosis, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction Therapy (PCIT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent-Child Interaction Therapy (PCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory (ECBI)
The ECBI is a norm-referenced caregiver report measure of disruptive behavior in children.
Measured: 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)
The BASC-3 is a norm-referenced caregiver report measure of broad behavior problems and adaptive skills in children.
Measured: Baseline, 6-month follow-up
Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3)
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.
Measured: Baseline, 6-month follow-up
Parenting Stress Index-4th Edition-Short Form (PSI-4-SF)
The PSI-4-SF is a norm-referenced self-report measure of parenting-related stress.
Measured: Baseline, 6-month follow-up
Dyadic Parent-Child Interaction Coding System (DPICS)
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.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up (delayed treatment group only)
Therapy Attitude Index (TAI)
The TAI measures treatment acceptability in PCIT.
Measured: 6-month follow-up (immediate treatment), 12-month follow-up (delayed treatment)
Telehealth Usability Questionnaire (TUQ)
The TUQ measures comfort with the use of telehealth methods pre- and post-treatment.
Measured: Baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)
Aberrant Behavior Checklist (ABC)
The ABC is a caregiver report questionnaire commonly used to measure problem behaviors and behavior change in children and adults with disabilities.
Measured: Baseline, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Aug 2022
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberous SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Nicole McDonald, PhD, University of California, Los Angeles
- Investigators
- Nicole McDonald, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311474
- Sponsor's protocol ID
- W81XWH-22-1-0250
- Other IDs
- TS210009
- Acronym
- RAINBOW
- Status last verified
- Mar 2026
- First submitted
- 29 Feb 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment of Behavior Problems in TSC at Preschool Age: A Telehealth Approach
- ClinicalTrials.gov ID
- NCT06311474
- Acronym / sponsor ID
- RAINBOW / W81XWH-22-1-0250
- Conditions
- Tuberous Sclerosis
- Keywords
- TAND, TSC, Behavior Problems, PCIT, TSC-Associated Neuropsychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Parent-Child Interaction Therapy (PCIT)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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- Elevated behavior problems
- Parent/caregiver available to participate in PCIT
Key exclusion criteria (4 listed)
- None
- Plan for epilepsy surgery during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate Treatment |
Primary outcome
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.
7 secondary outcomes
Behavior Assessment Scale for Children-3rd Edition (BASC-3)
Time frame: Baseline, 6-month follow-up
Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3)
Time frame: Baseline, 6-month follow-up
Parenting Stress Index-4th Edition-Short Form (PSI-4-SF)
Time frame: Baseline, 6-month follow-up
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)
Therapy Attitude Index (TAI)
Time frame: 6-month follow-up (immediate treatment), 12-month follow-up (delayed treatment)
Telehealth Usability Questionnaire (TUQ)
Time frame: Baseline & 6-month follow-up (immediate treatment), 6-month follow-up & 12-month follow-up (delayed treatment)
Aberrant Behavior Checklist (ABC)
Time frame: Baseline, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole McDonald, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Interaction Therapy (PCIT) in people with Tuberous Sclerosis, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.