TSC Remote Assessment and Intervention

NCT04698538 | Completed DMC

• 1 other identifier: 20-000010
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a study to adapt an evidence-based caregiver training program to improve access in order to better serve the TSC community. The proposed adapted caregiver training program is based on a targeted behavioral intervention called JASPER (Joint attention, symbolic play, engagement, and regulation) that has successfully improved outcomes in children with ASD. Importantly, JASPER specifically targets two key developmental domains known to be critical for young children with TSC, social communication and play. Recent work with JASPER in children with TSC shows promise, but still requires a commitment to regular in-person sessions. The investigators hope to test an adapted version of the caregiver training version of JASPER, where the entire training is provided remotely through weekly teleconferences and video feedback. The investigators goal is to determine if remote caregiver training can improve social engagement and communication between caregivers and their child with TSC. The investigators hope that by adapting the caregiver training version of JASPER to be delivered through telehealth methods, the investigators can help more families gain access to high quality training. There is a tremendous need for high quality early intervention, and remote caregiver training can give families the skills they need to make impactful and lasting improvements for their child with TSC. The investigators will recruit 66 children, 22 per year whom have been clinically diagnosed with TSC, are 12-36 months of age, English as primary language at home, and have one parent available for weekly remote video conferencing. Participants that meet criteria will be asked to complete assessments from their home (kits will be mailed to them), which will take several sessions (approximately 2.5 hours). During these assessment sessions via Zoom, participants will be shown how to do BOSA, SPACE and CCX assessments. A Vineland and Ages and Stages Questionnaire will also be done during these sessions, but it's just questionnaires. The SPACE and CCX are particulary important because the participants will have to record themselves throughout the study doing these assessments. A brief introduction to JASPER will also be given during this period of assessments. Randomization will occur after assessments are complete. Participants randomized to intervention will need to meet with the research staff for 12 weeks via Zoom to discuss their recorded sessions. Each participant in the intervention group is expected to submit (via UCLA Box) a 30-40 minute video doing JASPER with their child. These videos will be discussed during the Zoom calls. The group not randomized to intervention, will continue to care for their child as usual for those 12 weeks. They will not need to record or meet via Zoom with the research staff. At the end of the 12 weeks, all participants will record themselves doing the two assessments that were taught at UCLA. They will do and record these assessments again 12 weeks after that in the 3-month follow up. The total study is for 6 months.

Conditions

TSC

Keywords

TSC; tuberous sclerosis complex

Outcome Measures

Primary Outcomes (2)

• Change in Caregiver-Child Interaction (CCX)-joint engagement

  The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.

  entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

• Change in Short Play and Communication Evaluation (SPACE)- joint engagement

  The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.

  entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

Secondary Outcomes (2)

• Short Play and Communication Evaluation (SPACE)- Joint attention

  entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

• Short Play and Communication Evaluation (SPACE)- Play

  entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

Other Outcomes (4)

• Brief Observation of Symptoms of Autism (BOSA)

  entry (1st month of study)

• Ages and Stages Questionnaire

  screening, entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

• Vineland Adaptive Behavior Scale Third Edition (VABS-III)

  entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)

Study Arms (2)

Educational Materials

NO INTERVENTION

Caregivers in this arm will receive intervention material, but no coaching. The material consists of a self-guided module introducing caregivers to the developmental concepts of joint engagement, social communication, and play.

JASPER intervention

EXPERIMENTAL

The caregivers randomized to intervention, will meet twice a week with UCLA staff to do session planning one day and JASPER remote, live coaching another day. The caregivers are expected to meet with the UCLA team twice a week.

Behavioral: JASPER

Interventions

JASPER BEHAVIORAL

JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.

JASPER intervention

Eligibility Criteria

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

You may qualify if:

• Confirmed clinical diagnosis of TSC
• Chronological age of 12--36 months
• English as primary language at home
• Have a parent available for weekly remote video conferencing
• Scores of 22.5 Gross Motor and 25.14 Fine Motor on the Ages and Stages Questionnaire (ASQ).

You may not qualify if:

• Plan for epilepsy surgery during study period

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90024, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: People coding the data will not know the participants' treatment allocation and timepoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: January 7, 2021
• Study Start: October 31, 2020
• Primary Completion: August 31, 2024
• Study Completion: October 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

US (1)