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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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 c
Sponsor: University of California, Los Angeles

Current Primary Outcome:

• 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. [ Time Frame: 2 weeks ]
  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
• change from baseline in Joint Engagement (shared engagement in a play routine) at 3 months into study participation, according to the parent caregiver interaction assessment. [ Time Frame: 3 months ]
  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
• change from baseline in Joint Engagement (shared engagement in a play routine) at 6 months into study participation, according to the parent caregiver interaction assessment. [ Time Frame: 6 months ]
  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 2 weeks [ Time Frame: 2 weeks ]
  ESCS (Early Social Communication Scales) Assessment.
• Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 3 months [ Time Frame: 3 months ]
  ESCS (Early Social Communication Scales) Assessment.
• Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 6 months [ Time Frame: 6 months ]
  ESCS (Early Social Communication Scales) Assessment.
• Change from baseline in Symbolic Play (types of play and level of play) at 2 weeks, according to the Structured Play Assessment (SPA) [ Time Frame: 2 weeks ]
  The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
• Change from baseline in Symbolic Play (types of play and level of play) at 3 months, according to the Structured Play Assessment (SPA) [ Time Frame: 3 months ]
  The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
• Change from baseline in Symbolic Play (types of play and level of play) at 6 months, according to the Structured Play Assessment (SPA) [ Time Frame: 6 months ]
  The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
• Change from baseline at 3 months in developmental quotient, as determined by the Mullen Scales of Early Learning [ Time Frame: 3 months ]
  Cognition will be determined by a Developmental Quotient on a traditional cognitive measure, the Mullen Scales of Early Learning
• Change from baseline at 6 months in developmental quotient, as determined by the Mullen Scales of Early Learning [ Time Frame: 6 months ]
  Cognition will be determined by a Developmental Quotient on a traditional cognitive measure, the Mullen Scales of Early Learning
• Change from baseline at 2 weeks in the amount of Parent use of social communication support strategies [ Time Frame: 2 weeks ]
  Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.
• Change from baseline at 3 months in the amount of Parent use of social communication support strategies [ Time Frame: 3 months ]
  Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.
• Change from baseline at 6 months in the amount of Parent use of social communication support strategies [ Time Frame: 6 months ]
  Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: February 10, 2016
Date Started: September 2015
Date Completion: August 2017
Last Updated: February 19, 2016
Last Verified: February 2016