Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex
Condition: Tuberous Sclerosis Complex
MeSH terms: Tuberous Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Most children with Tuberous Sclerosis Complex (TSC) suffer from neurodevelopmental
      disabilities, including intellectual disability (ID) and autism spectrum disorder (ASD).
      There is a tremendous need for early intervention for all infants with TSC, with a focus on
      improving non-verbal cognition and social communication skills. However, no studies have
      investigated whether early intervention can improve social communication skills in infants
      with TSC. As a result, families of infants with TSC struggle to receive adequate
      interventions targeting these areas of development.

      The investigators propose to enroll 32 infants and toddlers with TSC to study an
      evidence-based behavioral intervention in infants with TSC, combining the efforts of
      investigators with expertise in autism intervention, infant development, and TSC. The
      proposed intervention study adapts a parent-mediated treatment called JASPER (Joint
      attention, symbolic play, engagement, regulation) that has successfully improved social
      communication outcomes in toddlers and young children with ASD.

      JASPER intervention will last 3 months, and is split into two phases. Phase 1 occurs for the
      first 2 weeks of intervention, and consists of daily 1 hour intervention sessions (Monday
      through Friday) for 2 weeks. After Phase 1, Phase two begins, and consists of 60 minute
      sessions once a week for 10 weeks. Participants will receive behavioral assessments and EEG
      across 4 assessment time points during this study: At the start of participation in the
      study, two weeks into participation of the study, 3 months into participation of the study,
      and 6 months into participation in the study. The behavioral assessments administered
      throughout these time points will measure social communication skills, overall cognitive
      functioning, and non-verbal communication. EEG is sensitive to subtle changes in the brain
      and may be able to capture responses to treatment prior to clinical or behavioral change, and
      can inform researchers of the brain basis for the behavioral changes found with intervention.
      The EEG at each time point will be 30-45 minutes in length, and will require the participant
      to be awake, as they will watch several short videos on a tv screen while recording EEG data.

      There are 2 randomized participation groups in this study, Treatment Group 1, and Treatment
      Group 2. Treatment group 1 will begin JASPER intervention immediately, and thus will complete
      the first 3 assessment time points while in intervention, and the 4th assessment time point 3
      months after intervention ends. Treatment Group 2 will complete the 4 assessment time points
      while receiving services as usual in the community, and will begin intervention after the 4th
      assessment time point. Treatment group 1 will participate in this study for a total of 6
      months, and treatment group 2 will participate in the study for a total of 9 months, since
      they will receive services in the community as usual for 6 months before beginning the 3
      month intervention. Group assignment is randomized, and each participant has an equal chance
      of being assigned to either treatment group.
    

Intervention name(s): JASPER
Intervention type(s): Behavioral
Intervention description(s): JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari and Dr. Amanda Gulsrud at UCLA. It targets the foundations of social communication (joint attention, imitation, play) and uses naturalistic strategies to increase the rate and complexity of social communication.
Other intervention name(s): Joint Attention, Symbolic Play and Engagement Regulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment