Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome (NCT05638412) | Clinical Trial Compass
CompletedNot Applicable
Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome
United States103 participantsStarted 2023-01-23
Plain-language 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. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.
Who can participate
Age range
36 Months – 90 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Mosaic Down syndrome
* Significant and uncorrected hearing and/or vision problems
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Joint engagement and joint attention skills
Timeframe: 20 weeks
2
Social communication skills
Timeframe: 20 weeks
3
Caregiver use of behavioral strategies
Timeframe: 20 weeks
4
Language, socialization, play, problem behavior, and adaptive skills