JASPER Early Intervention for Tuberous Sclerosis

NCT03422367 | Unknown

• 2 other identifiers: IRB #17-0002621R01HD090138-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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; ESCS is an experimental measure reported as frequency for requesting and joint attention in 15-minute intervals

  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; ESCS is an experimental measure reported as frequency for requesting and joint attention in 15-minute intervals

  6 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 3 months into study participation, according to the parent caregiver interaction assessment.

  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.

  6 months

• Structured Play Assessment (SPA)

  Change from baseline in Symbolic Play (types of play and level of play) at 3 months; this is an experimental measure reported as types of behaviors reflecting flexibility and diversity of the child's play level, based on distinct sets of toys that target specific developmental markers of play.

  3 months

• SPA

  Change from baseline in Symbolic Play (types of play and level of play) at 6 months; this is an experimental measure reported as types of behaviors reflecting flexibility and diversity of the child's play level, based on distinct sets of toys that target specific developmental markers of play.

  6 months

• Mullen Scales of Early Learning (MSEL)

  Measures cognitive ability and language development (baseline to 3 months). The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. The test identifies the subject's strengths and weaknesses and assesses early intellectual development.

  3 months

• Mullen

  Measures cognitive ability and language development (baseline to 6 months). The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. The test identifies the subject's strengths and weaknesses and assesses early intellectual development.

  6 months

• Social communication

  Change from baseline at 3 months in the amount of Parent use of social communication support strategies Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.

  3 months

• Social communication

  Change from baseline at 3 months in the amount of Parent use of social communication support strategies Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.

  6 months

Study Arms (3)

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

Control

NO INTERVENTION

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

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: 6 Months - 40 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
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Boston Children's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90065, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• Hyde C, Pizzano M, McDonald NM, Nelson CA 3rd, Kasari C, Thiele EA, Jeste SS. A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex. J Neurodev Disord. 2020 Jan 22;12(1):3. doi: 10.1186/s11689-019-9302-0.

  PMID: 31969108 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tuberous Sclerosis; Autistic Disorder; Epilepsy; Child Development Disorders, Pervasive

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; Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shafali Jeste

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Hyde

CONTACT

3108258738; chyde@mednet.ucla.edu

Web:

CONTACT

www.JETSstudy.org; JETSstudy@gmail.com

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: Director of Developmental Neurophysiology Lab

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: October 24, 2017
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

US (2)