Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex

Completed · Not applicable

Conditions studied: Tuberous Sclerosis Complex

In brief

The investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that may improve social and communication skills in children with TSC. Eligible families will have a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be available to attend the weekly intervention sessions at UCLA. The intervention will focus on teaching caregivers skills to improve the social and communication outcomes of their children. The content of the intervention will be individually tailored to the child's developmental level. The intervention involves pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3 parent-child dyad and the curriculum focuses on improving social-communication and play skills.

Key facts

Study ID

NCT02687633

Run by

University of California, Los Angeles

People needed

8

Starts

2015-09-01

Expected to finish

2017-08-01

Last updated by the study team

2026-07-23

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A confirmed diagnosis of Tuberous Sclerosis Complex

You may not qualify if…

• A mental age less than 6 months. A plan for epilepsy surgery during the study participation period.

Where it is running

• UCLA Semel Insitute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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