Recruiting

JASPER

Sponsor:

UCLA

Code:

NCT03422367

Conditions

Tuberous Sclerosis

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

JASPER

Study Details

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 administered remotely 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. Children with TSC below 12 months may be eligible for an early markers study prior to enrollment in the intervention trial.

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 4 on-site assessment visits, and 12 weekly intervention sessions, administered in-person and remotely. The intervention focuses on improving social-communication and play skills.

Conditions

Tuberous Sclerosis

Study ID

NCT03422367

Start date

Oct 24, 2017

Status verified date

Nov, 2020

Completion date

Jun 15, 2022

Anticipated

Primary completion date

Jun 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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

active comparator: 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.

no intervention: Control

Participants who are unable to complete JASPER due to age or time/distance commitment can enroll for single-time point participation

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.

Primary outcome measure

  • ESCS (Early Social Communication Scales) Assessment. [ Time Frame: 3 months ]
  • ESCS (Early Social Communication Scales) 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. [ Time Frame: 3 months ]
  • Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine. [ Time Frame: 6 months ]
  • Structured Play Assessment (SPA) [ Time Frame: 3 months ]
  • SPA [ Time Frame: 6 months ]
  • Mullen Scales of Early Learning (MSEL) [ Time Frame: 3 months ]
  • Mullen [ Time Frame: 6 months ]
  • Social communication [ Time Frame: 3 months ]
  • Social communication [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Carly Hyde

3108258738chyde@mednet.ucla.edu

Web:

www.JETSstudy.orgJETSstudy@gmail.com

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90065

Contacts

Carly Hyde, BS

310-825-8738chyde@mednet.ucla.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jack Keller

857-218-3010Jack.Keller@childrens.harvard.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Nov 6, 2020

Last verified

Nov, 2020

Keywords

  • autism
  • epilepsy
  • asd
  • TSC
  • UCLA
  • Los Angeles
  • JASPER
  • intervention
  • Boston
  • BCH
  • MGH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2020-11-06.