JASPER Intervention in Down Syndrome

NCT03653143 | Completed

• 1 other identifier: IRB-P00025806
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome, Trisomy 21

Keywords

Behavioral regulation; Emotional regulation; Social communication; Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in cognition

  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)

  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)

  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)

  Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months)

• Change in social-communication skills (part b)

  Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months)

Other Outcomes (2)

• Change in social-communication skills (in relation to electrophysiology)

  EEG will be measured at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)

• Change in social-communication skills (in relation to electrophysiology)

  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)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Assessment #1 Baseline Visit \>\> 3 month JASPER intervention (weekly) \>\> Assessment #2 Research Visit \>\> 3 month treatment as usual \>\> Assessment #3 Research Visit

Behavioral: JASPER

Control/Wait-list Group

EXPERIMENTAL

Assessment #1 Baseline Visit \>\> 3 month treatment as usual \>\> Assessment #2 Research Visit \>\> 3 month JASPER intervention \>\> Assessment #3 Research Visit

Behavioral: JASPER

Interventions

JASPER BEHAVIORAL

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.

Control/Wait-list Group; Treatment Group

Eligibility Criteria

• Age: 24 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Mosaic / Translocation Down syndrome

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 16712638 BACKGROUND

• 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.

  PMID: 22525955 BACKGROUND

MeSH Terms

Conditions

Down Syndrome; Emotional Regulation; Communication

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Officials

• Nicole Baumer, MD, MEd

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 31, 2018
• Study Start: December 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

US (1)