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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,692 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