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PRISM Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883139
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Connie Kasari, Ph.D., University of California, Los Angeles

Brief Summary:
This research study, Personalized, Responsive Intervention Sequences for Minimally Verbal Children with Autism (PRISM), is designed to maximize language outcomes for limited-language preschoolers, thereby lowering the risk of being classified as "minimally verbal" at age 6, by empirically developing a two-stage, 20-week adaptive intervention approach in a real world community settings. If found efficacious, the adaptive intervention design will capitalize on the heterogeneity and evolving status of children with ASD by providing the best intervention (DTT, JASPER and CET) for children who need it (leading to individualized sequences of intervention), only when it is needed (potentially reducing burden on children).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: JASPER Behavioral: DTT (Discrete Trial Training) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Personalized, Responsive Intervention Sequences for Minimally Verbal Children With Autism
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: JASPER

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing JASPER. If the child is an early responder, he/she will remain in the same course for the following 10 weeks.

If child is a slow responder, he/she will be randomized for either combined & enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified JASPER for 3 hours a week (3 days, 1 hour per day).

Behavioral: JASPER
JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child.

Active Comparator: DTT

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing DTT. If the child is an early responder, he/she will remain in the same course for the following 10 weeks.

If child is a slow responder, he/she will be randomized for either combined & enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified DTT for 3 hours a week (3 days, 1 hour per day).

Behavioral: DTT (Discrete Trial Training)
DTT is an adult-led, highly structured, behavioral teaching approach, is considered to have the strongest evidence as a "standard of care" for young children with autism. DTT emphasizes didactic, adult-led instruction.




Primary Outcome Measures :
  1. Change of spontaneous utterances (SCU) from the Language Sample throughout the study. [ Time Frame: baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6 ]
    To determine which intervention for minimally verbal children (JASPER vs. DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).


Secondary Outcome Measures :
  1. Change in Joint Engagement on the Caregiver-Child Play Interaction (CCX) over the course of the study. [ Time Frame: baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6 ]

    A 10-minute interaction between parent and child. These sessions will be carried out with a standard set of toys and videotaped.

    Parents will be asked to engage their child in play as usual. Coders blind to child treatment assignment and time point will code the videotapes according to Adamson et al, 2004 coding procedures, the same as used in our previous studies (Harris, Kasari, & Sigman, 1996; Kasari et al, 2006; Kasari, et al, 2008). Joint engagement change will be recorded and measured throughout the study.


  2. Change in receptive language using the Preschool Language Scales-5 (PLS-5) throughout the study. [ Time Frame: baseline (entry), 20 weeks, and when child turns 6 ]
    Children's receptive language skills (age equivalent in months) will be measured by the Preschool Language Scales-5 (PLS-5) and presence of word combinations at the age six assessment. A child will be classified verbal if he/she meets the PLS-5 expressive item benchmark for word combinations. Children who do not show word combinations on the Language Sample or PLS-5 will be considered minimally verbal for this analysis.

  3. Presence of word combinations in the Language Sample over the course of the study. [ Time Frame: baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6 ]
    The LS will be used to address the probability that a child is classified as verbal at age 6. So tracking word combinations throughout the study is important. A child is considered verbal if s/he shows multiple, flexible word combinations during the Language Sample (a mean length of utterance- MLU- totaling at least 1.8 following conventions for establishing word combinations by Tager Flusberg et al. (2009), and meets the PLS-5 expressive item benchmark for word combinations. Children who do not show word combinations on the Language Sample or PLS-5 will be considered minimally verbal for this analysis.


Other Outcome Measures:
  1. Presence of joint attention initiations using the Early Social-Communication Scales [ Time Frame: baseline (entry) ]
    In this semi-structured interaction, the child and tester sit facing each other at a table with a set of toys in view but out of reach of the child which are introduced one by one (Mundy, Sigman, Ungerer, & Sherman, 1986; Seibert, Hogan, & Mundy, 1982). The joint attention initiations will then be coded.

  2. Track the levels of spontaneous play acts using The Structured Play Assessment-R over the course of the study. [ Time Frame: baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6 ]
    SPA-R is designed to obtain the child's highest levels of spontaneous play acts. The child is presented with 5 different play sets by the experimenter; the entire play interaction last about 15-20 minutes. The child's play behaviors are videotaped and later coded. The variables of interest include the frequency of child initiated functional and symbolic play acts and also the count of different novel types of acts. This measure has shown excellent reliability and validity across a range of studies (Kasari et al., 2006; Sigman & Ruskin, 1999; Sigman & Ungerer, 1984).

  3. Child diagnostic assessment (ADOS-2) [ Time Frame: baseline (entry) ]
    Confirm child's diagnosis.

  4. Vineland III Interview [ Time Frame: baseline (entry) ]
    Adaptive behavior composite

  5. Determine eligibility on nonverbal mental age using the Mullen Scales of Early Learning (MSEL) [ Time Frame: baseline (entry) ]
    Nonverbal Development Quotients (DQ) (DQ; mental age ÷ chronological age)

  6. Demographic and Medical Questionnaire [ Time Frame: baseline (entry) ]
    Descriptive measure to determine child's eligibility.

  7. Determine severity of challenge and improvement in Engagement and SCU in interventionist session using the Clinical Global Impressions (CGI) [ Time Frame: baseline (entry), week 10 after entry, and week 20 after entry ]
    Ratings are conducted using a 7 point behaviorally anchored scale ranging from 1 (very much improved) to 7 (very much worse). Scores of 1 or 2 (much or very much improved) are considered early response, while scores of 3 (minimal improvement) and below are considered slow response.



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Ages Eligible for Study:   48 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children meeting ADOS-2 criteria for ASD,
  • age 48-59 months
  • who have had > 3 months early intervention/preschool (to ensure that children already have been exposed to some community interventions) and
  • use < 20 functional words (i.e., non-echoed, non-scripted).

Additional inclusion criteria are:

  • stable medication over the past 6 months, and
  • nonverbal mental age of >12 months on the Mullen Scales of Early Learning (visual reception and fine motor subscales).

Exclusion Criteria:

  • We will exclude children who have sensory and motor impairments (e.g., visual impairment, deaf or hard of hearing) and with known genetic syndromes (e.g., Down Syndrome).
  • We will not exclude on the basis of AAC exposure, but expect few will be exposed at these ages.

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): NCT03883139


Contacts
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Contact: Connie Kasari, PhD 310-825-8342 kasari@gseis.ucla.edu
Contact: Consuelo Garcia, BS 310-825-4775 cogarcia@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles

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Responsible Party: Connie Kasari, Ph.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03883139    
Other Study ID Numbers: 19-000193
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 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 Connie Kasari, Ph.D., University of California, Los Angeles:
autism
JASPER
DTT
ASD
Autism Spectrum Disorder
social and communication deficits
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders