JASPER Intervention in Down Syndrome

Down Syndrome, Trisomy 21 Clinical Trial

Official title:

Pilot Study of JASPER in Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653143
• Other study ID #: IRB-P00025806
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Down Syndrome, Trisomy 21
• Syndrome

Intervention

Behavioral:
• JASPER
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: J Child Psychol Psychiatry. 2007 May;48(5):523. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in social-communication skills (in relation to electrophysiology)	Resting state electroencephalogram (EEG) power will be measured as a potential moderator of treatment on change in joint engagement (baseline to end of treatment). EEG procedures will be conducted using a previously established JASPER EEG protocol.	EEG will be measured at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
Other	Change in social-communication skills (in relation to electrophysiology)	Electroencephalogram (EEG) is brain monitoring method that will be used to measure brain activity. EEG power will first be measured during "resting state". Brain activity in response to low-level visual processing, low-level auditory processing, and face processing will then be measured using event-related potentials (ERPs).	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Link to homepage of the Kasari Lab where the JASPER intervention was developed