JASPER Intervention in Down Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in Down syndrome (DS). The investigators will also explore the potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with DS. EEG and ERP measure may also help to predict treatment outcome.

Official Title
-----------------
Pilot Study of JASPER in Down Syndrome

Conditions
-----------------
Down Syndrome, Trisomy 21

Intervention / Treatment
-----------------
* Behavioral: JASPER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Trisomy 21 Age 24-48 months Able to walk independently across a room Uses at least 5 words / signs English speaking Parent able to accompany participant to all study visits Exclusion Criteria: -Diagnosis of Mosaic / Translocation Down syndrome

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 48 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will initially undergo brief telephone screen to assess eligibility. Parents/guardians will complete surveys during the Baseline assessment and ERP/EEG testing will be done for participants who are able to undergo their assessments in-person. Participants will then be randomly assigned to either the treatment group or the control/waitlist group. The immediate group will start with 3 months of JASPER intervention and then have 3 months of their usual clinical care. The control/waitlist group will start with 3 months of their usual clinical care and then undergo 3 months of JASPER intervention. The 3-month treatment phase will involve weekly sessions with the JASPER interventionist, each 60 minutes long. Surveys and ERP/EEG assessments (as possible) will be repeated at the 3 month and at 6 month research visits for all participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Assessment #1 Baseline Visit >> 3 month JASPER intervention (weekly) >> Assessment #2 Research Visit >> 3 month treatment as usual >> Assessment #3 Research Visit | Behavioral: JASPER<br>* JASPER is a therapist and parent-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 parents 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.<br>|
| Experimental: Control/Wait-list Group<br>Assessment #1 Baseline Visit >> 3 month treatment as usual >> Assessment #2 Research Visit >> 3 month JASPER intervention >> Assessment #3 Research Visit | Behavioral: JASPER<br>* JASPER is a therapist and parent-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 parents 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Joint Engagement | Joint engagement will be measured by coded videos of the Caregiver Child Interaction (CCX) session. CCX measures the amount of time that parent and child engage during a play session. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition | For in-person participation only, composite scores from the Mullen Scales of Early Learning (MSEL) will be used to measure cognition and language development. Composite scores are calculated averages based on MSEL subscales 1) Gross motor 2) Visual reception 3) Fine motor 4) Receptive language 5) Expressive language. Higher composite scores are associated with higher cognitive and language functioning. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 
| Change in language, socialization, problem behavior, adaptive skills (part a) | Subscales of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) will be used to measure language, socialization, problem behaviors and adaptive skills. VABS-II subscales include 1) Communication 2) Daily living skills 3) Socialization, and 4) Motor skills. Behavior frequency is measured on a range of 0=Never to 1=Sometimes to 2=Usually. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 
| Change in language, socialization, problem behavior, adaptive skills (part b) | The Aberrant Behavior Checklist-Community (ABC-C) will also be used to measure language, socialization, problem behavior, and adaptive skills for in-person participation. ABC-C subscales include 1) Irritability 2) Lethargy 3) Stereotypy 4) Hyperactivity, and 5) Inappropriate speech and are measured on a range of 0=not at all a problem to 3=the problem is severe in degree. The MacArthur-Bates Communicative Development Inventories (MB-CDI) will replace the ABC-C for virtual participation. The MB-CDI is a parent report instrument that captures important information about children's developing abilities in early language, including 1) Vocabulary comprehension 2) Production 3) Gestures, and 4) Grammar. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 
| Change in social-communication skills (part a) | Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) will be used to measure social communication skills for in-person participation. ADOS-2 subscales include areas like 1) Language and communication and 2) Reciprocal social interaction. Items within each subscale are scored on unique ranges starting with 0=closest to mastery of behavior. The Autism Diagnostic Interview - Revised (ADI-R) will replace the ADOS for virtual participation. The ADI-R is a comprehensive parent interview that focuses on three functional domains of behavior that are not typically present in individuals without autism spectrum disorder. The three domains are: Language/Communication, Reciprocal Social Interactions, and Restricted, Repetitive, and Stereotyped Behaviors and Interests. | Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) | 
| Change in social-communication skills (part b) | The Early Social Communication Scales (ESCS) is an experimental measurement that measures change in social-communication skills. It will be used for in-person participation only. The ESCS uses tasks to measure the frequency of initiation of and response to 1) Joint attention 2) Behavioral requests, and 3) Social interaction. The PICS will replace the ESCS for virtual participation. The PICS uses photographs to aid caregivers in understanding and identifying the specific behaviors of interest. Modeled after the ESCS, the PICS assesses various forms and functions of triadic attention in young children. | Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) | 
| Change in joint attention skills | The Caregiver Child Interaction sessions (CCX) and Early Social Communication Scales (ESCS) or Pictorial Infant Communication Scale (PICS) will be used to measure changes in joint attention skills. ESCS, which will only be used for in-person participation, uses tasks to measure the frequency of the child's initiation and response (see above). The PICS will replace the ESCS for virtual participation. The PICS uses photographs to aid caregivers in understanding and identifying the specific behaviors of interest. Modeled after the ESCS, the PICS assesses various forms and functions of triadic attention in young children. The CCX, which will be used for in-person and virtual participation, measures the amount of time that parent and child engage during a play session. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 
| Change in play levels | Flexibility and diversity of play will be coded from the Structured Play Assessment (SPA) for in-person participation only. Different toys are presented to the child, and play interaction is measured in terms of 1) Functional play types 2) Symbolic play types, and 3) Play level. | Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Development, Behavioral regulation, Emotional regulation, Social communication