# Mechanisms of change with early intervention in Tuberous Sclerosis Complex

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $518,724

## Abstract

PROJECT SUMMARY/ABSTRACT
Background: Children with Tuberous Sclerosis Complex (TSC) are at high risk for neurodevelopmental
disorders, with rates of autism spectrum disorder (ASD) approaching 60%. Prospective studies have found that
infants with TSC demonstrate delays in social communication skills in the first year of life. However, to date no
studies have investigated whether early behavioral intervention can improve social communication skills in
infants with TSC. Objectives: The overarching goal of the study is to determine if social communication
function can be improved in infants with TSC with a targeted, short-term behavioral intervention called
JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), and to enrich traditional outcome
measures by combining behavioral measures with electrophysiological (EEG) biomarkers of social
communication. These biomarkers can capture subtle changes in brain development that may reflect
responses to treatment prior to an overt behavioral change, particularly relevant for children with significantly
delayed development, and they can inform the neural mechanisms underlying the behavioral changes found
with intervention. Hypothesis: It is expected that, compared to a wait list control group, infants receiving the
JASPER intervention will demonstrate greater gains in social communication skills, with changes captured both
behaviorally and electrophysiologically. Methodology: A total of 60 infants with TSC ages 12-36 months will
be recruited across two sites with an established collaboration in TSC research, UCLA and Boston Children's
Hospital, with each infant randomized to treatment or wait list control group. The wait list control design allows
all infants to receive intervention while still maintaining a non-treatment comparison group. Treatment will
consist of 12 weeks of weekly intervention sessions. Assessments (clinical, behavioral and EEG) will be
performed before treatment, after treatment, 3 months after completion, and then 12 months after completion.
Controls will undergo assessments at the same time points, and then will start intervention at month 6.
Assessments will include behavioral measures of social communication skills, cognition, language and
adaptive function, and EEG measure of resting state brain activity, visual and face processing. Impact: Early
intervention improves cognitive and behavioral outcomes in ASD, yet no studies have investigated the effects
of targeted, early behavioral intervention in infants with TSC. Evidence of efficacy of early intervention will
justify its value for all infants with TSC, improving developmental outcomes and attenuating symptoms that
lead to the diagnosis of neurodevelopmental disabilities in TSC. Moreover, this study holds relevance for
intervention research across neurodevelopmental disorders through its integration of EEG biomarkers with
behavioral measures, as such methodology may more readily capture the effects of treatment in pre-ve...

## Key facts

- **NIH application ID:** 9921443
- **Project number:** 5R01HD090138-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Shafali Spurling Jeste
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $518,724
- **Award type:** 5
- **Project period:** 2017-07-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9921443

## Citation

> US National Institutes of Health, RePORTER application 9921443, Mechanisms of change with early intervention in Tuberous Sclerosis Complex (5R01HD090138-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9921443. Licensed CC0.

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