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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

Tracking Information
First Submitted Date  ICMJE June 4, 2014
First Posted Date  ICMJE June 6, 2014
Last Update Posted Date July 12, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02158390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2014)
  • Receptive language [ Time Frame: up to 3 months ]
    Receptive language is assessed by child performance on the PLS-5, a standardized language assessment.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2014)
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.
Original Other Pre-specified Outcome Measures
 (submitted: June 5, 2014)
Parent use of Jasper-EMT strategies [ Time Frame: up to 3 months ]
Observations of parent-child interactions are coded to determine parent use of key intervention strategies.
 
Descriptive Information
Brief Title  ICMJE Phenotypic Specific Communication Intervention for Children With Down Syndrome
Official Title  ICMJE Phenotypic Specific Communication Intervention for Children With Down Syndrome
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.
Detailed Description

This is a two-site randomized controlled trial (RCT) of the efficacy of JASP-EMT, an innovative blended communication intervention, JASPER (joint engagement and play intervention), and EMT (Enhanced Milieu Teaching). The study evaluates the relative benefits of teaching young children with DS using dual communication modes: spoken words with AAC. JASP-EMT involves direct intervention with children as well as parent training in an attempt to increase generalization of intervention effects. A control group will receive community treatment as usual (BAU). Participants include 82 children with DS ages 30 to 54 months across two sites.

AIM 1: To examine the effects of an experimental intervention (Words + AAC) on primary (expressive language) and secondary outcomes (receptive language, symbolic play, symbol-infused joint engagement, and parent use of language support strategies).

H1: Children in the Words+AAC group will have significantly better primary and secondary outcomes than children in the control group.

H2: Parents of children in Words+AAC group will demonstrate increased use of language support strategies than parents of children in the control group.

AIM 2: To examine maintenance and generalization of the effects of the experimental interventions on children and their parents.

H3: Intervention effects will maintain at follow-up and generalize across contexts.

AIM 3 (exploratory): To examine the effect of potential child level moderators on the primary and secondary outcomes of the study.

H4: Child characteristics at baseline (e.g., speech intelligibility, cognitive level) will moderate primary child outcomes.

AIM 4 (exploratory): To examine the effect of the experimental intervention on executive functioning.

H5: Children in the Words+AAC group will demonstrate improved executive functioning following intervention relative to the children in the control group.

Participants

A total of 82 children and their parents will be recruited to the study (41 at Vanderbilt and 41 at UCLA). Child MA of 18 months ensures children have the cognitive skills for symbolic representation in communication. The sample is expected to be 40% minority with equal numbers of males and females. Most parents are expected to be lower to upper middle class mothers.

Summary of Intervention

The goal of the intervention is to help children with DS develop expressive language skills that will improve participation in social, academic and community environments. Children will receive direct intervention from a therapist; additionally, parents will be taught to use the Words + AAC strategies in the clinic and at home across routines. Therapists use all strategies throughout the intervention; parents learn strategies sequentially.

Length of Intervention: 4/week for 4 months (48 sessions); 40 minute clinic sessions, 60 minute home sessions Type of Intervention sessions: 6 workshops, 18 clinic training sessions, 24 home training sessions Mode: AAC (iPad) and verbal input and output Maintenance: every six weeks for 6 months after completion of the intervention

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Language Impairment
  • Down Syndrome
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Jasper-EMT with words and AAC
  • No Intervention: Community treatment as usual
    Children access educational and speech-language interventions available to them through schools and community resources.
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
78
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2014)
82
Actual Study Completion Date  ICMJE February 6, 2018
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 54 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02158390
Other Study ID Numbers  ICMJE 05302014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This project does not require a data sharing plan. Results will be reported on profession journals.
Responsible Party Ann Kaiser, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Ann P Kaiser, PhD Vanderbilt University
Study Director: Connie Kasari, PhD University of California, Los Angeles
PRS Account Vanderbilt University
Verification Date July 2018

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