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

NCT ID: NCT02687633

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-08-31

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.

Conditions

Tuberous Sclerosis Complex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

JASPER

Intervention Type: BEHAVIORAL

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.

Delayed Treatment Group

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.

Group Type: ACTIVE_COMPARATOR

JASPER

Intervention Type: BEHAVIORAL

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.

Interventions

JASPER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Joint Attention, Symbolic Play and Engagement Regulation

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Shafali Jeste, MD

Assistant Professor in Psychiatry and Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shafali Jeste, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Semel Insitute

Los Angeles, California, United States

Countries

United States

Other Identifiers

15-000699

Identifier Type: -

Identifier Source: org_study_id