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

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Brief Title

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

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 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.
    


Study Type

Interventional


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.

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

Condition

Tuberous Sclerosis Complex

Intervention

JASPER

Study Arms / Comparison Groups

 Treatment Group
Description:  The Treatment Group begins the JASPER intervention immediately upon enrollment in the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

8

Start Date

September 2015

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        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.
      

Gender

All

Ages

12 Months - 36 Months

Accepts Healthy Volunteers

No

Contacts

Shafali Jeste, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02687633

Organization ID

15-000699


Responsible Party

Principal Investigator

Study Sponsor

University of California, Los Angeles

Collaborators

 Boston Children's Hospital

Study Sponsor

Shafali Jeste, MD, Principal Investigator, University of California, Los Angeles


Verification Date

April 2018