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 3-6 years
Able to walk independently
English speaking
Caregiver able to complete either 1:1 virtual coaching sessions or psychoeducational behavioral curriculum
Exclusion Criteria:
Mosaic / Translocation Down syndrome
Significant and uncorrected hearing and/or vision problems
Diagnosis of Autism Spectrum Disorder (ASD): If a child does already carry a diagnosis of ASD, they will be excluded from the study
Intervention
Intervention Type
Intervention Name
Behavioral
JASPER
Behavioral
Psychoeducational Curriculum
Phase
Not Applicable
Gender
All
Min Age
36 Months
Max Age
72 Months
Download Date
November 18, 2023
Principal Investigator
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
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: