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Trial record 40 of 167 for:    trisomy21 NOT prenatal

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

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03653143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2018)
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE JASPER Intervention in Down Syndrome
Official Title  ICMJE Pilot Study of JASPER in Down Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Down Syndrome, Trisomy 21
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: JASPER
  • 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
    Intervention: Behavioral: JASPER
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margaret Hojlo, BA 617-919-6435 downsyndrome.research@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653143
Other Study ID Numbers  ICMJE IRB-P00025806
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicole Baumer, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicole Baumer, MD, MEd Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP