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Behavioural Intervention

Remote JASPER Training for TSC (TRAIN Trial)

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scores of 22.5 Gross Motor and 25.14 Fine Motor on the Ages and Stages Questionnaire (ASQ)
Chronological age of 12--36 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Awards & highlights

TRAIN Trial Summary

This trial will test if a remote version of the Jasper caregiver training program can help improve social engagement and communication between caregivers and their child with TSC.

Who is the study for?
This trial is for young children aged 12-36 months with Tuberous Sclerosis Complex (TSC), who speak English at home and have a parent available for weekly video calls. They must also meet certain developmental milestones on the Ages and Stages Questionnaire. Children planning to undergo epilepsy surgery during the study period cannot participate.Check my eligibility
What is being tested?
The trial tests an adapted caregiver training program delivered remotely, using JASPER (Joint attention, symbolic play, engagement, regulation) techniques designed to improve social communication and play in children with TSC. The effectiveness of remote training via teleconferences will be compared against usual care without intervention.See study design
What are the potential side effects?
Since this is a behavioral intervention involving caregiver training rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience varying levels of stress or fatigue associated with the commitment to regular sessions.

TRAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child's motor skills scored 22.5 for gross motor and 25.14 for fine motor on the ASQ.
Select...
I am between 1 and 3 years old.
Select...
I have been diagnosed with Tuberous Sclerosis Complex.

TRAIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Caregiver-Child Interaction (CCX)-joint engagement
Change in Short Play and Communication Evaluation (SPACE)- joint engagement
Secondary outcome measures
Short Play and Communication Evaluation (SPACE)- Joint attention
Short Play and Communication Evaluation (SPACE)- Play
Other outcome measures
Ages and Stages Questionnaire
Brief Observation of Symptoms of Autism (BOSA)
Demographic and Medical Questionnaire
+1 more

TRAIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: JASPER interventionExperimental Treatment1 Intervention
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.
Group II: Educational MaterialsActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JASPER
2018
N/A
~20

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,275,967 Total Patients Enrolled

Media Library

JASPER (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04698538 — N/A
Tuberous Sclerosis Complex Research Study Groups: Educational Materials, JASPER intervention
Tuberous Sclerosis Complex Clinical Trial 2023: JASPER Highlights & Side Effects. Trial Name: NCT04698538 — N/A
JASPER (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04698538 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to participate in this experiment?

"Patients with TSC within the range of 1 year to 3 years of age are invited to enroll in this trial. 66 participants will be accepted into this research study."

Answered by AI

What is the sample size of this clinical research?

"That is correct. The information hosted on clinicaltrials.gov presents the trial, which was initially announced on October 31st 2020, as presently looking for participants. 66 patients are needed to be recruited from 1 site."

Answered by AI

Is the age limitation of this trial restricted to those above 55 years old?

"The clinical trial necessitates that applicants be in the 12-36 Month age bracket. Additionally, there are two distinct trials for minors and one specifically designed for senior citizens above 65 years of age."

Answered by AI

Are there any vacancies in this medical experiment for participants?

"Affirmative. The clinicaltrials.gov page reveals that this investigation is currently recruiting patients; the listing was first published on October 31st 2020 and recently updated on November 10th 2022, with a requirement of 66 participants at one research centre."

Answered by AI
~3 spots leftby May 2024