Clinical trial NCT05638412: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Parent Coaching
Parent Education
Social Communication
Play Skills
Behavioral regulation
Development
Emotional regulation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 57
Sex: ALL
Minimum age (years): 36
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Joint engagement and joint attention skills
timeFrame: 20 weeks
measure: Social communication skills
timeFrame: 20 weeks
measure: Caregiver use of behavioral strategies
timeFrame: 20 weeks
measure: Language, socialization, play, problem behavior, and adaptive skills
timeFrame: 20 weeks
measure: Socialization and play skills
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: