JASPER Intervention in Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-07-31

Brief Summary

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The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in Down syndrome (DS). The investigators will also explore the potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with DS. EEG and ERP measure may also help to predict treatment outcome.

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Detailed Description

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Conditions

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Down Syndrome, Trisomy 21

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will initially undergo brief telephone screen to assess eligibility. Parents/guardians will complete surveys during the Baseline assessment and ERP/EEG testing will be done for participants who are able to undergo their assessments in-person. Participants will then be randomly assigned to either the treatment group or the control/waitlist group. The immediate group will start with 3 months of JASPER intervention and then have 3 months of their usual clinical care. The control/waitlist group will start with 3 months of their usual clinical care and then undergo 3 months of JASPER intervention. The 3-month treatment phase will involve weekly sessions with the JASPER interventionist, each 60 minutes long. Surveys and ERP/EEG assessments (as possible) will be repeated at the 3 month and at 6 month research visits for all participants.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment Group

Assessment #1 Baseline Visit \>\> 3 month JASPER intervention (weekly) \>\> Assessment #2 Research Visit \>\> 3 month treatment as usual \>\> Assessment #3 Research Visit

Group Type EXPERIMENTAL

JASPER

Intervention Type BEHAVIORAL

JASPER is a therapist and parent-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 parents 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.

Control/Wait-list Group

Assessment #1 Baseline Visit \>\> 3 month treatment as usual \>\> Assessment #2 Research Visit \>\> 3 month JASPER intervention \>\> Assessment #3 Research Visit

Group Type EXPERIMENTAL

JASPER

Intervention Type BEHAVIORAL

JASPER is a therapist and parent-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 parents 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.

Interventions

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JASPER

JASPER is a therapist and parent-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 parents 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Trisomy 21
* Age 24-48 months
* Able to walk independently across a room
* Uses at least 5 words / signs
* English speaking
* Parent able to accompany participant to all study visits