What side effects are associated with this type of intervention?

Behavioral and psychoeducational interventions like JASPER Behavioral Therapy, which focus on enhancing joint attention, symbolic play, engagement, and regulation through structured caregiver coaching, generally have minimal physical side effects. Potential side effects may include emotional or psychological stress for both the child and caregiver, frustration due to slow progress, and possible burnout from the intensive nature of the therapy.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the cognitive or behavioral symptoms of Down Syndrome. Treatments often focus on managing co-occurring conditions such as congenital heart defects, thyroid issues, and gastrointestinal problems. Behavioral therapies, like the JASPER Behavioral Therapy being studied, aim to improve developmental outcomes through structured caregiver coaching, enhancing skills such as joint attention, symbolic play, engagement, and regulation. These therapies are crucial for supporting the developmental needs of children with Down Syndrome.

What other types of research exist?

Promising alternatives to JASPER Behavioral Therapy for Down Syndrome patients include: 1) Early Start Denver Model (ESDM), which integrates play-based routines to improve cognitive and social skills; 2) Pivotal Response Treatment (PRT), focusing on motivation and response to multiple cues; and 3) DIR/Floortime, emphasizing emotional and relational development through interactive play. These therapies offer structured approaches to enhance engagement and developmental outcomes.

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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

Must not have

Significant and uncorrected hearing and/or vision problems

Mosaic / Translocation Down syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the impact of JASPER therapy, which involves one-on-one coaching for caregivers of children with Down syndrome. The goal is to improve children's play, attention, and interaction skills, as well as caregiver confidence and effectiveness. JASPER is a naturalistic developmental behavioral intervention that has been shown to improve social communication, play skills, and language skills in children.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major hearing or vision issues that haven't been corrected.

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I have a specific type of Down syndrome.

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My child does not have a diagnosis of Autism Spectrum Disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver use of behavioral strategies

Joint engagement and joint attention skills

Language, socialization, play, problem behavior, and adaptive skills

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~80

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

JASPER Behavioral Therapy focuses on enhancing joint attention, symbolic play, engagement, and regulation through structured caregiver coaching. The mechanisms of action include structured interactions that promote social communication skills, play-based activities that develop cognitive and motor skills, and caregiver involvement that ensures consistent application of strategies. These interventions are crucial for Down Syndrome patients as they address core developmental challenges, improve social interactions, and support overall cognitive and emotional development.

Addressing sequelae of developmental regression associated with developmental disabilities: A systematic review of behavioral and educational intervention studies.