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

NCT02687633 | Completed

• 1 other identifier: 15-000699
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberous Sclerosis Complex

Outcome Measures

Primary Outcomes (3)

• 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.

  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.

  2 weeks

• 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.

  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.

  3 months

• 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.

  Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.

  6 months

Secondary Outcomes (11)

• 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

  2 weeks

• 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

  3 months

• 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

  6 months

• Change from baseline in Symbolic Play (types of play and level of play) at 2 weeks, according to the Structured Play Assessment (SPA)

  2 weeks

• Change from baseline in Symbolic Play (types of play and level of play) at 3 months, according to the Structured Play Assessment (SPA)

  3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Behavioral: JASPER

Delayed Treatment Group

ACTIVE COMPARATOR

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.

Behavioral: JASPER

Interventions

JASPER 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.

Also known as: Joint Attention, Symbolic Play and Engagement Regulation

Delayed Treatment Group; Treatment Group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A confirmed diagnosis of Tuberous Sclerosis Complex

You may not qualify if:

• A mental age less than 6 months. A plan for epilepsy surgery during the study participation period.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

UCLA Semel Insitute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Tuberous Sclerosis

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Officials

• Shafali Jeste, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Psychiatry and Neurology

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 22, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

US (1)