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JASPER Therapy for Down Syndrome

N/A
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of Trisomy 21
Age 3-6 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights

Study Summary

This trial will compare two different interventions to help caregivers support their child's development and behavior.

Who is the study for?
This trial is for children aged 3-6 with confirmed Trisomy 21 Down Syndrome who can walk and speak English. Their caregiver must be able to do virtual coaching or learn a behavioral curriculum. Children with mosaic/translocation Down syndrome, major hearing/vision issues, or autism cannot join.Check my eligibility
What is being tested?
The study compares JASPER behavioral therapy—a one-on-one coaching method—with a self-taught psychoeducational curriculum for caregivers of children with Down Syndrome to see which better improves child development and behavior.See study design
What are the potential side effects?
Since this trial involves educational and behavioral interventions rather than medications, there are no direct medical side effects; however, changes in behavior or stress levels could potentially occur as a result of the new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Down syndrome.
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I am between 3 and 6 years old.
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I can walk on my own without help.
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My caregiver can attend virtual coaching or learn through online courses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver use of behavioral strategies
Joint engagement and joint attention skills
Language, socialization, play, problem behavior, and adaptive skills
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Psychoeducational Curriculum GroupExperimental Treatment1 Intervention
Caregivers receiving the 10 weekly psychoeducational curriculum modules will be provided with the resources via secure email and encouraged to engage with the material a self-directed manner. The psychoeducational modules will include written information about child development, communication and social interaction skills, behavioral principles for managing challenging behavior and strategies for teaching new skills. No direct caregiver-child mediated coaching will be provided. The content of the modules will include information about developmental milestones in this age group for children with DS, behavior management strategy recommendations, positive parenting materials, and materials on increasing engagement through play.
Group II: JASPER Intervention GroupExperimental Treatment1 Intervention
Caregivers receiving the JASPER intervention will undergo weekly virtual 60-minute sessions for 10 weeks conducted via Zoom. The content of the intervention includes teaching and implementation of contingent responding and specific strategies to provide a high-quality response to children's communication, and play behaviors. Caregiver training is completed through review of pre-recorded videos of the caregiver-child dyad each week. The first half of each session will be dedicated to reviewing previous content and feedback on the play recording. The following half will consist of new material. The coaching support includes contingent responding, the parent is also taught to use specific strategies to provide a rich, high-quality response to children's communication, and play behaviors.
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?

Boston Children's HospitalLead Sponsor
760 Previous Clinical Trials
5,579,642 Total Patients Enrolled
4 Trials studying Down Syndrome
88 Patients Enrolled for Down Syndrome

Media Library

JASPER Clinical Trial Eligibility Overview. Trial Name: NCT05638412 — N/A
Down Syndrome Research Study Groups: JASPER Intervention Group, Psychoeducational Curriculum Group
Down Syndrome Clinical Trial 2023: JASPER Highlights & Side Effects. Trial Name: NCT05638412 — N/A
JASPER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638412 — N/A

Frequently Asked Questions

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

Is enrollment for this clinical trial ongoing at the moment?

"Based on the clinicaltrials.gov records, this trial has concluded recruitment with its last edit occurring in December 2nd 2022., Nevertheless, there are currently 1406 other trials actively looking for participants."

Answered by AI

May I register for this experiment?

"This clinical trial seeks 38 individuals with Down syndrome aged 3-6 years old to participate. Essential criteria for entry into the study includes a confirmed diagnosis of Trisomy 21, proficiency in English, and being able to walk unaided alongside having a caregiver who can complete virtual coaching sessions or behavioural courses."

Answered by AI

Is eligibility restricted to individuals over the age of 20 for this experiment?

"This medical trial is only open to participants aged between 3 and 6 years old, with 383 trials for minors and 990 for seniors."

Answered by AI
~18 spots leftby Apr 2025