Clinical trial NCT03653143: JASPER Intervention in Down Syndrome
Official title: Pilot Study of JASPER in Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome, Trisomy 21
Keywords: Behavioral regulation
Emotional regulation
Social communication
Development
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in Joint Engagement
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
Secondary outcomes:
measure: Change in cognition
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
measure: Change in language, socialization, problem behavior, adaptive skills (part a)
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
measure: Change in language, socialization, problem behavior, adaptive skills (part b)
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
measure: Change in social-communication skills (part a)
timeFrame: Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months)
measure: Change in social-communication skills (part b)
timeFrame: Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months)
measure: Change in joint attention skills
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
measure: Change in play levels
timeFrame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
Other outcomes:
measure: Change in social-communication skills (in relation to electrophysiology)
timeFrame: EEG will be measured at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
measure: Change in social-communication skills (in relation to electrophysiology)
timeFrame: ERP visual, auditory, and face processing will be measured at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Nicole Baumer, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.
citation: Kasari C, Gulsrud A, Freeman S, Paparella T, Hellemann G. Longitudinal follow-up of children with autism receiving targeted interventions on joint attention and play. J Am Acad Child Adolesc Psychiatry. 2012 May;51(5):487-95. doi: 10.1016/j.jaac.2012.02.019. Epub 2012 Apr 6.