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JASPER Intervention in Down Syndrome

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ClinicalTrials.gov Identifier: NCT03653143
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole Baumer, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Down Syndrome, Trisomy 21 Behavioral: JASPER Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will initially undergo brief telephone screen to assess eligibility. Inclusion in this study will be limited to children who are currently able to: walk across a room independently, use at least 5 words/signs. Participants will complete a series of survey and ERP/EEG assessments during the Baseline visit. After completion of the Baseline visit, participants will be randomly assigned to either the treatment group or the control/waitlist group. Group assignment will be random. The treatment 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. Survey and ERP/EEG assessments will be repeated at the 3 month and at 6 month research visits for all participants.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of JASPER in Down Syndrome
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: Treatment Group
Assessment #1 Baseline Visit >> 3 month JASPER intervention (weekly) >> Assessment #2 Research Visit >> 3 month treatment as usual >> Assessment #3 Research Visit
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.

Experimental: Control/Wait-list Group
Assessment #1 Baseline Visit >> 3 month treatment as usual >> Assessment #2 Research Visit >> 3 month JASPER intervention >> Assessment #3 Research Visit
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.




Primary Outcome Measures :
  1. Change in Joint Engagement [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    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.


Secondary Outcome Measures :
  1. Change in cognition [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    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.

  2. Change in language, socialization, problem behavior, adaptive skills (part a) [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    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.

  3. Change in language, socialization, problem behavior, adaptive skills (part b) [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    The Aberrant Behavior Checklist-Community (ABC-C) will also be used to measure language, socialization, problem behavior, and adaptive skills. 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.

  4. Change in social-communication skills (part a) [ Time Frame: Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) ]
    Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) will be used to measure social communication skills. 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.

  5. Change in social-communication skills (part b) [ Time Frame: Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) ]
    The Early Social Communication Scales (ESCS) is an experimental measurement that also measures change in social-communication skills. The ESCS uses tasks to measure the frequency of initiation of and response to 1) Joint attention 2) Behavioral requests, and 3) Social interaction.

  6. Change in joint attention skills [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    The Early Social Communication Scales (ESCS) and Caregiver Child Interaction sessions (CCX) will be used to measure change in joint attention skills. ESCS uses tasks to measure the frequency of the child's initiation and response (see above). CCX measures the amount of time that parent and child engage during a play session.

  7. Change in play levels [ Time Frame: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    Flexibility and diversity of play will be coded from the Structured Play Assessment (SPA). 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.


Other Outcome Measures:
  1. Change in social-communication skills (in relation to electrophysiology) [ Time Frame: EEG will be measured at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) ]
    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.

  2. Change in social-communication skills (in relation to electrophysiology) [ Time Frame: 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) ]
    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).



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Ages Eligible for Study:   36 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Trisomy 21
  • Age 36-48 months
  • Able to walk independently across a room
  • Uses at least 5 words / signs
  • English speaking
  • Developmental level based on MSEL score of at least 6 months
  • Parent able to accompany participant to all study visits

Exclusion Criteria:

  • Diagnosis of Mosaic / Translocation Down syndrome
  • Diagnosis of Autism Spectrum Disorder (ASD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653143


Contacts
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Contact: Margaret Hojlo, BA 617-919-6435 downsyndrome.research@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Margaret Hojlo, BA    617-919-6435    downsyndrome.research@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Nicole Baumer, MD, MEd Boston Children’s Hospital

Additional Information:
Publications:
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Responsible Party: Nicole Baumer, Principle Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03653143     History of Changes
Other Study ID Numbers: IRB-P00025806
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicole Baumer, Boston Children’s Hospital:
Behavioral regulation
Emotional regulation
Social communication
Development

Additional relevant MeSH terms:
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Syndrome
Down Syndrome
Trisomy
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Aneuploidy
Chromosome Aberrations
Chromosome Duplication