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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how two different approaches can help children with Down syndrome develop better communication and social skills. One group will participate in JASPER (Joint Attention Symbolic Play Engagement & Regulation), a therapy involving personalized coaching sessions for caregivers to enhance their child's play and communication. The other group will receive educational materials for self-guided learning about child development and behavior management. The trial seeks children aged 3-7 with Down syndrome who can walk independently and have caregivers willing to participate in virtual sessions or self-guided learning. As an unphased trial, this study offers families a unique opportunity to contribute to understanding and improving developmental therapies for children with Down syndrome.

Will I have to stop taking my current medications?

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

What prior data suggests that these interventions are safe for children with Down Syndrome?

A previous study found that JASPER therapy helped young children with Down syndrome (DS) improve their social engagement and emotional regulation. No harmful effects were reported, indicating it is generally well-tolerated.

The psychoeducational curriculum offers written information and resources for caregivers to learn at their own pace. This approach is typically safe, as it involves no physical or medical treatments.

Both interventions aim to enhance communication and play skills in children with DS. Research suggests they are safe options for caregivers and their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the JASPER therapy and the psychoeducational curriculum because they offer innovative approaches to supporting children with Down syndrome. Unlike traditional therapies that might focus solely on direct child interventions, JASPER involves caregivers in weekly virtual coaching sessions, teaching them to enhance their children's communication and play skills through contingent responding. This caregiver-focused method could empower families to become active participants in their child's development. Meanwhile, the psychoeducational curriculum provides caregivers with self-directed modules on child development and behavior management, potentially offering a more accessible and flexible alternative to in-person therapy sessions. These approaches may help fill gaps in current treatments by actively involving caregivers and providing them with the tools to support developmental milestones at home.

What evidence suggests that this trial's interventions could be effective for Down Syndrome?

In this trial, participants will be assigned to one of two groups. Research has shown that JASPER therapy, which participants in the JASPER Intervention Group will receive, can help young children with Down Syndrome improve their ability to connect with others and manage their emotions. Studies have found that children who receive JASPER therapy communicate and play better. This therapy teaches caregivers how to respond effectively to their child's communication and play signals.

Participants in the Psychoeducational Curriculum Group will receive resources to help caregivers understand child development and manage behaviors. Evidence suggests this approach offers valuable insights into important stages of child development and effective parenting techniques. While it doesn't include direct coaching, it aims to equip caregivers with the knowledge and tools needed to support their child's development. ^{1 2 3 6 7}

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39047661/

The JASPER (Joint Attention, Symbolic Play, Engagement ... JASPER may be a viable treatment option to improve joint engagement and emotion regulation in young children with DS.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0891422224001288

The JASPER (Joint Attention, Symbolic Play, Engagement ... JASPER may be a viable treatment option to improve joint engagement and emotion regulation in young children with DS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03653143

NCT03653143 | JASPER Intervention in Down Syndrome The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05638412

Investigating the Impact of JASPER Behavioral Therapy in ... In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, ...

5. researchgate.net researchgate.net/publication/383633404_The_JASPER_Joint_Attention_Symbolic_Play_Engagement_and_Regulation_Intervention_in_Down_Syndrome_A_pilot_study

The JASPER (Joint Attention, Symbolic Play, Engagement ... The JASPER (Joint Attention, Symbolic Play, Engagement and Regulation) Intervention in Down Syndrome: A pilot study ... Results revealed that children with Down ...

6. withpower.com withpower.com/trial/phase-down-syndrome-11-2022-11701

JASPER Therapy for Down Syndrome · Info for Participants This trial studies the impact of JASPER therapy, which involves one-on-one coaching for caregivers of children with Down syndrome.

7. pubs.asha.org pubs.asha.org/doi/10.1044/2021_PERSP-21-00222

Development and Usability Testing of a Web-Based ... The project includes formative work to develop a technology-enabled adaptation of the evidence-based caregiver-mediated Joint Attention, Symbolic Play, ...