Clinical trial · Interventional
Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JASPER | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- The Treatment Group begins the JASPER intervention immediately upon enrollment in the study.
- interventionNames
- Behavioral: JASPER
- type
- ACTIVE_COMPARATOR
- label
- Delayed Treatment Group
- description
- The Delayed treatment group receives the same JASPER intervention as the Treatment Group, but after 6 months of receiving services in the community as usual.
- interventionNames
- Behavioral: JASPER
Primary outcomes (3)
- measure
- change from baseline in Joint Engagement (shared engagement in a play routine) at 2 weeks into study participation, according to the parent caregiver interaction assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 36 Months
Show eligibility criteria text
Inclusion Criteria: * A confirmed diagnosis of Tuberous Sclerosis Complex Exclusion Criteria: * A mental age less than 6 months. A plan for epilepsy surgery during the study participation period.
References
Publications (0)
Data not yet available