JASPER Therapy for Down Syndrome

Overseen By Sophie Hurewitz

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Mosaic Down syndrome, Hearing, Vision

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is JASPER therapy safe for humans?

The available research on JASPER therapy, primarily focused on children with autism, does not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is the JASPER treatment for Down Syndrome different from other treatments?

JASPER therapy is unique because it focuses on improving joint attention, symbolic play, engagement, and regulation, which are critical developmental areas for children with Down Syndrome. Unlike other treatments, it uses naturalistic developmental behavioral techniques to enhance play and communication skills, making it distinct from more traditional therapies. ^{1 4 5 6 7}

What data supports the effectiveness of the JASPER treatment for Down Syndrome?

Research shows that children with Down syndrome can develop play skills similar to typically developing children when engaged in collaborative play, which is a key component of JASPER. Additionally, symbolic play, which is part of JASPER, is linked to cognitive development in children with Down syndrome. ^{2 5 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English speaking

I have been diagnosed with Down syndrome.

I am between 3 and 6 years old.

Exclusion Criteria

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

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

I have a specific type of Down syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the JASPER intervention or a psychoeducational curriculum for 10 weeks

10 weeks

10 weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JASPER
• Psychoeducational Curriculum

Trial Overview 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.

How Is the Trial Designed?

Group I: Psychoeducational Curriculum Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

JASPER is already approved in United States for the following indications:

Approved in United States as JASPER for:

• Autism Spectrum Disorder (ASD), specifically for improving social communication and play skills in minimally verbal children

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

The JASPER intervention, which focuses on joint attention, play skills, and language development, showed significant improvements in these areas for children with autism spectrum disorder compared to those who did not receive the intervention, based on a review of 19 studies.

While parents and educators generally found the JASPER techniques effective, the studies reviewed did not meet all quality indicators, indicating a need for further research to explore the broader impacts of JASPER on children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of JASPER intervention for children with autism spectrum disorder: A systematic review. Waddington, H., Reynolds, JE., Macaskill, E., et al.[2021]

In a pilot study involving minimally verbal children with autism aged 3 to 5, the JASPER intervention showed significant improvements in play diversity and engagement compared to a control group receiving standard ABA therapy.

The JASPER treatment, which included just 30 minutes of intervention twice a week, led to increased initiation of gestures and reduced unengaged time in the classroom, highlighting its potential effectiveness in addressing core deficits in autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. Goods, KS., Ishijima, E., Chang, YC., et al.[2021]

The JASPER intervention significantly improved play skills in 109 preschool-age children with autism, enhancing both the diversity and complexity of their play compared to control groups.

Children who showed more joint attention skills at the start of the intervention made even greater improvements in their play skills, highlighting the importance of targeting both play and joint attention in autism interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental Play Skills as Outcomes of Early Intervention. Chang, YC., Shire, S., Shih, W., et al.[2023]

A review of 21 studies on early interventions for infants and children with Down's syndrome showed consistent short-term improvements in fine motor skills, social skills, and developmental quotients (DQ/IQ), but mixed results in gross motor, language, and cognitive skills.

Long-term follow-up indicated that the initial gains from these interventions did not persist into the early years of primary schooling, suggesting a need for more effective and tailored intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregated early intervention effects for Down's syndrome persons: patterning and longevity of benefits. Gibson, D., Harris, A.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Mother-child play: children with Down syndrome and typical development. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pretend play and patterns of cognition in Down's syndrome children. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

From infant affect expression to symbolic play: the coherence of development in Down syndrome children. [2007]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Virtual and Computational Technologies in the Psychomotor and Cognitive Development of Children with Down Syndrome: A Systematic Literature Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Mental ability, symbolic play and receptive and expressive language of young children with Down's syndrome. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The effects of JASPER intervention for children with autism spectrum disorder: A systematic review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developmental Play Skills as Outcomes of Early Intervention. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of a naturalistic sign intervention on expressive language of toddlers with Down syndrome. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Aggregated early intervention effects for Down's syndrome persons: patterning and longevity of benefits. [2019]