Current Environment:

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.

Conditions

Down Syndrome

Recruitment Status

RECRUITING

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

BEHAVIORAL

JASPER

BEHAVIORAL

Psychoeducational Curriculum

Phase

NA

Gender

ALL

Min Age

36 Months

Max Age

90 Months

Download Date

2024-06-03

Principal Investigator

Nicole Baumer, MD, MEd         

Linnea Joffe-Nelson, RN, MA  

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Sophie Hurewitz
dsjasperstudy@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome NCT05638412 Sophie Hurewitz dsjasperstudy@childrens.harvard.edu