Down SyndromeNCT05638412
Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome
A study testing JASPER and Psychoeducational Curriculum in people with Down Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Read more about this study
- Who is it for?
- Ages 36 to 90 months
- Conditions the study is for
- Down Syndrome
- What is being tested?
- JASPER and Psychoeducational Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 90 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of Trisomy 21
- Age 3-7 years
- Able to walk independently
- English speaking
- Caregiver able to complete either 1:1 virtual coaching sessions or psychoeducational behavioral curriculum
Who cannot join
- Mosaic Down syndrome
- Significant and uncorrected hearing and/or vision problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02445
About this study
In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.
Read the detailed description
Down syndrome (DS), the most common genetic cause of intellectual disability, can be associated with a wide range of developmental needs. Behavioral challenges are common, and can impact learning, overall achievement, relationships, inclusion in schools, and community integration.
The goal of this study is to determine whether JASPER (Joint Attention Symbolic Play Engagement and Regulation) can improve caregiver implementation of behavioral strategies, caregiver self-efficacy and confidence, and child development.
Participants will be randomized to receive either the JASPER intervention or a caregiver psychoeducational group. Participants in the JASPER intervention will receive 10 weekly virtual educational sessions utilizing JASPER therapy modules through 1:1 parent-child coaching sessions. Caregivers in the comparison group will receive 10 weekly modules containing a psychoeducational curriculum. The outcome measures will assess caregiver responsiveness, child joint engagement with caregiver, caregiver self-efficacy, and child behavior, language, and adaptive skills.
- Conditions
- Down Syndrome
- Being tested
- JASPER, Psychoeducational Curriculum
- Keywords
- Parent Coaching, Parent Education, Social Communication, Play Skills, Behavioral regulation, Development, Emotional regulation
- Medical subject headings
- Down Syndrome, Communication, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASPERBehavioural
JASPER is a therapist and caregiver-mediated intervention that (1) targets the foundations of social communication, (2) uses naturalistic behavioral strategies to increase the rate and complexity of social communication and (3) includes caregivers as implementers of the intervention to promote generalization across settings and to ensure maintenance. This intervention is individualized and centered around two key developmental domains critical for social communication function: joint engagement and joint attention.
Psychoeducational CurriculumBehavioural
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 material provided will be similar to what a pediatrician or developmental specialist may review as a part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| JASPER Intervention Group | Experimental | 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. Receives: Behavioral: JASPER |
| Psychoeducational Curriculum Group | Experimental | 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. Receives: Behavioral: Psychoeducational Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint engagement and joint attention skills
Joint engagement and joint attention skills will be coded from Caregiver-Child Interaction (CCX) video recordings. The 15-minute CCX videos measure the amount of time that caregiver and child engage during a play session. The frequency of the child's engagement states will be coded using an Engagement State Coding Scheme to measure proportion of video during which child is maintaining Joint Engagement (shared engagement in a play routine).
Measured: 20 weeks
Social communication skills
Social communication skills will be coded from Caregiver-Child Interaction (CCX) video recordings. The 15-minute CCX videos measure the amount of time that caregiver and child engage during a play session. A Social Communication Coding Scheme will measure the child's social communication skills. This coding scheme includes various social communication items and "Yes" or "No" codes to measure social communication skill development over time. Increasing answers of "Yes" indicate growth in social communication skills.
Measured: 20 weeks
Caregiver use of behavioral strategies
The frequency with which caregivers use behavioral strategies will be collected from a weekly caregiver Behavioral Strategy Log.
Measured: 20 weeks
Language, socialization, play, problem behavior, and adaptive skills
Language, socialization, play, problem behavior, and adaptive skills measured by a parent interview about development using the Vineland Adaptive Behavior Scales (VABS-III). Behavior frequency is measured on a range of 0=Never to 1=Sometimes to 2=Usually.
Measured: 20 weeks
Socialization and play skills
Socialization and play skill development measured by the Play Assessment Questionnaire. The Play Assessment Questionnaire includes "Yes" or "No" items about play skills, symbolic play types and routines, and play level. This caregiver questionnaire measures play skill development over time. Increasing answers of "Yes" indicate growth in play skills.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start23 Jan 2023
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Wilkinson, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638412
- Sponsor's protocol ID
- P00043317
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05638412
- Acronym / sponsor ID
- P00043317
- Conditions
- Down Syndrome
- Keywords
- Parent Coaching, Parent Education, Social Communication, Play Skills, Behavioral regulation, Development, Emotional regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.
Detailed description
Down syndrome (DS), the most common genetic cause of intellectual disability, can be associated with a wide range of developmental needs. Behavioral challenges are common, and can impact learning, overall achievement, relationships, inclusion in schools, and community integration.
The goal of this study is to determine whether JASPER (Joint Attention Symbolic Play Engagement and Regulation) can improve caregiver implementation of behavioral strategies, caregiver self-efficacy and confidence, and child development.
Participants will be randomized to receive either the JASPER intervention or a caregiver psychoeducational group. Participants in the JASPER intervention will receive 10 weekly virtual educational sessions utilizing JASPER therapy modules through 1:1 parent-child coaching sessions. Caregivers in the comparison group will receive 10 weekly modules containing a psychoeducational curriculum. The outcome measures will assess caregiver responsiveness, child joint engagement with caregiver, caregiver self-efficacy, and child behavior, language, and adaptive skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JASPER Intervention Group | Experimental | Behavioral: JASPERCaregivers 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. |
| Psychoeducational Curriculum Group | Experimental | Behavioral: Psychoeducational CurriculumCaregivers 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. |
Who may qualify
- Ages
- 36 to 90 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Trisomy 21
- Age 3-7 years
- Able to walk independently
- English speaking
- Caregiver able to complete either 1:1 virtual coaching sessions or psychoeducational behavioral curriculum
Key exclusion criteria (2 listed)
- Mosaic Down syndrome
- Significant and uncorrected hearing and/or vision problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JASPERJASPER is a therapist and caregiver-mediated intervention that (1) targets the foundations of social communication, (2) uses naturalistic behavioral strategies to increase the rate and complexity of social communication and (3) includes caregivers as implementers of the intervention to promote generalization across settings and to ensure maintenance. This intervention is individualized and centered around two key developmental domains critical for social communication function: joint engagement and joint attention. | Behavioural | JASPER Intervention Group |
| Psychoeducational CurriculumThe 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 material provided will be similar to what a pediatrician or developmental specialist may review as a part of routine care. | Behavioural | Psychoeducational Curriculum Group |
Primary outcome
Joint engagement and joint attention skills
Time frame: 20 weeks
Joint engagement and joint attention skills will be coded from Caregiver-Child Interaction (CCX) video recordings. The 15-minute CCX videos measure the amount of time that caregiver and child engage during a play session. The frequency of the child's engagement states will be coded using an Engagement State Coding Scheme to measure proportion of video during which child is maintaining Joint Engagement (shared engagement in a play routine).
Social communication skills
Time frame: 20 weeks
Social communication skills will be coded from Caregiver-Child Interaction (CCX) video recordings. The 15-minute CCX videos measure the amount of time that caregiver and child engage during a play session. A Social Communication Coding Scheme will measure the child's social communication skills. This coding scheme includes various social communication items and "Yes" or "No" codes to measure social communication skill development over time. Increasing answers of "Yes" indicate growth in social communication skills.
Caregiver use of behavioral strategies
Time frame: 20 weeks
The frequency with which caregivers use behavioral strategies will be collected from a weekly caregiver Behavioral Strategy Log.
Language, socialization, play, problem behavior, and adaptive skills
Time frame: 20 weeks
Language, socialization, play, problem behavior, and adaptive skills measured by a parent interview about development using the Vineland Adaptive Behavior Scales (VABS-III). Behavior frequency is measured on a range of 0=Never to 1=Sometimes to 2=Usually.
Socialization and play skills
Time frame: 20 weeks
Socialization and play skill development measured by the Play Assessment Questionnaire. The Play Assessment Questionnaire includes "Yes" or "No" items about play skills, symbolic play types and routines, and play level. This caregiver questionnaire measures play skill development over time. Increasing answers of "Yes" indicate growth in play skills.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASPER and Psychoeducational Curriculum in people with Down Syndrome, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint engagement and joint attention skills (time frame: 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.