Down Syndrome Clinical Trial
— MerckOfficial title:
Phenotypic Specific Communication Intervention for Children With Down Syndrome
NCT number | NCT02158390 |
Other study ID # | 05302014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | February 6, 2018 |
Verified date | July 2018 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | February 6, 2018 |
Est. primary completion date | August 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Months to 54 Months |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles Center for Autism Research and Treatment | Los Angeles | California |
United States | Vanderbilt University Kennedy Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parent use of Joint Attention Symbolic Play Engagement and Regulation- Enhanced Milieu Teaching ( Jasper-EMT) strategies | Observations of parent-child interactions are coded to determine parent use of key intervention strategies. | up to 3 months | |
Primary | Spoken language | Spoken language is measured by transcribing child utterances ( spoken and AAC generated ) during 20 minute naturalistic language samples. Linguistic analysis are automated, via SALT. | up to 3 months | |
Secondary | Receptive language | Receptive language is assessed by child performance on the Preschool Language Scale 5th Edition ( PLS-5), a standardized language assessment. | up to 3 months | |
Secondary | Executive Functioning | Children's executive functioning abilities will be assessed across a variety of tasks measuring persistence, planning, and attention. | up to 3 months |
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