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

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Down Syndrome

Treatments: Behavioral: Psychoeducational Curriculum; Behavioral: JASPER

Study type: Interventional

Funder types: Other

Identifiers

NCT05638412

P00043317

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 36 to 90 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

JASPER Intervention Group

Experimental group

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.

Treatment:

Behavioral: JASPER

Psychoeducational Curriculum Group

Experimental group

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.

Treatment:

Behavioral: Psychoeducational Curriculum