Phenotypic Specific Communication Intervention for Children With Down Syndrome

NCT02158390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-07-12

No results posted yet for this study

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.

Conditions

  • Language Impairment
  • Down Syndrome

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ann P Kaiser, PhD · Vanderbilt University

  • Connie Kasari, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
54 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-08-30
Completion
2018-02-06

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158390 on ClinicalTrials.gov