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Phenotypic Specific Communication Intervention for Children With Down Syndrome (Merck)

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ClinicalTrials.gov Identifier: NCT02158390
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Ann Kaiser, Vanderbilt University

Brief Summary:
Children with Down syndrome (DS) have greater difficulty acquiring expressive language than is predicted by their general cognitive abilities and language comprehension (Miller, 1999). To date, interventions to improve communication outcomes for children with DS have met with only modest success. The proposed study is a randomized controlled trial of an early communication intervention combining two evidence-based treatments that teach expressive communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC). The intervention (a) teaches the foundations of communication (joint attention, play), (b) builds on positive child characteristics of social attention, (c) uses naturalistic strategies to increase the rate and complexity of communication and increase task engagement, (d) addresses the potential value of adding visual support (AAC) to spoken communication, and (e) includes parents as implementers of the intervention to promote generalization across settings and activities, and to ensure maintenance over time. It is hypothesized that children with DS enrolled in the intervention will have better language and communication skills at the end of treatment and followup than children in the BAU comparison group.The study will enroll 82 30 to 54 month old children with DS who have fewer than 20 words. Examining predictors of response to treatment and the effects of treatment on executive functioning will inform both theory and practice.

Condition or disease Intervention/treatment Phase
Language Impairment Down Syndrome Behavioral: Jasper-EMT with words and AAC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phenotypic Specific Communication Intervention for Children With Down Syndrome
Study Start Date : June 2014
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: Jasper-EMT with words and AAC

Jasper-EMT with words and AAC

A therapist plus parent implemented social communication intervention which include use of the iPad for a mode of communication. A total of 6 hour long workshops with the parent and 42 hour long intervention sessions with the child occur; half include the parent as therapist and occur in the home. The treatment lasts approximately 4 months.

Behavioral: Jasper-EMT with words and AAC

Jasper-EMT with words and AAC

A therapist plus parent implemented social communication intervention which include use of the iPad for a mode of communication. A total of 6 hour long workshops with the parent and 42 hour long intervention sessions with the child occur; half include the parent as therapist and occur in the home. The treatment lasts approximately 4 months.


No Intervention: Community treatment as usual
Children access educational and speech-language interventions available to them through schools and community resources.



Primary Outcome Measures :
  1. Spoken language [ Time Frame: up to 3 months ]
    Spoken language is measured by transcribing child utterances ( spoken and AAC generated ) during 20 minute naturalistic language samples. Linguistic analysis are automated, via SALT.


Secondary Outcome Measures :
  1. Receptive language [ Time Frame: up to 3 months ]
    Receptive language is assessed by child performance on the Preschool Language Scale 5th Edition ( PLS-5), a standardized language assessment.

  2. Executive Functioning [ Time Frame: up to 3 months ]
    Children's executive functioning abilities will be assessed across a variety of tasks measuring persistence, planning, and attention.


Other Outcome Measures:
  1. Parent use of Joint Attention Symbolic Play Engagement and Regulation- Enhanced Milieu Teaching ( Jasper-EMT) strategies [ Time Frame: up to 3 months ]
    Observations of parent-child interactions are coded to determine parent use of key intervention strategies.



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Ages Eligible for Study:   30 Months to 54 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of DS from medical records.
  2. Mental age (MA) of 18 months as measured on the Visual Reception subtest of the Mullen Scales of Early Learning.
  3. Expressive vocabulary of fewer than 20 words at measured on a naturalistic language sample.
  4. Age between 30 and 54 months
  5. English or Spanish as the primary language at home.
  6. Parents who are willing to participate in parent training.

Exclusion Criteria:

1. Major medical conditions other than DS, specifically (a) developmental disorders (e.g. autism); (b) sensory disabilities (e.g. blindness/deafness), and (c) motor disabilities not related to DS, (e.g. cerebral palsy)


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): NCT02158390


Locations
United States, California
University of California, Los Angeles Center for Autism Research and Treatment
Los Angeles, California, United States, 90024
United States, Tennessee
Vanderbilt University Kennedy Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
University of California, Los Angeles
Investigators
Principal Investigator: Ann P Kaiser, PhD Vanderbilt University
Study Director: Connie Kasari, PhD University of California, Los Angeles

Responsible Party: Ann Kaiser, Susan W. Gray Professor of Education and Human Development, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02158390     History of Changes
Other Study ID Numbers: 05302014
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This project does not require a data sharing plan. Results will be reported on profession journals.

Keywords provided by Ann Kaiser, Vanderbilt University:
Down syndrome
Language intervention
Communication intervention

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Language Disorders
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Communication Disorders
Signs and Symptoms