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Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JASPER
Psychoeducational Curriculum
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Parent Coaching, Parent Education, Social Communication, Play Skills, Behavioral regulation, Development, Emotional regulation

Eligibility Criteria

36 Months - 72 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JASPER Intervention Group

Psychoeducational Curriculum Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
Caregiver use of behavioral strategies
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2022
Last Updated
August 8, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05638412
Brief Title
Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome
Official Title
Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Parent Coaching, Parent Education, Social Communication, Play Skills, Behavioral regulation, Development, Emotional regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JASPER Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducational Curriculum Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
JASPER
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Curriculum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Joint engagement and joint attention skills
Description
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).
Time Frame
20 weeks
Title
Social communication skills
Description
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.
Time Frame
20 weeks
Title
Caregiver use of behavioral strategies
Description
The frequency with which caregivers use behavioral strategies will be collected from a weekly caregiver Behavioral Strategy Log.
Time Frame
20 weeks
Title
Language, socialization, play, problem behavior, and adaptive skills
Description
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.
Time Frame
20 weeks
Title
Socialization and play skills
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Hurewitz
Phone
857-218-4779
Email
dsjasperstudy@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Hurewitz
Phone
857-218-4779
Email
dsjasperstudy@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Nicole Baumer, MD, MEd
First Name & Middle Initial & Last Name & Degree
Linnea Joffe-Nelson, RN, MA

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome

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