Phenotypic Specific Communication Intervention for Children With Down Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 78
- Locations
- 4
- Primary Endpoint
- Spoken language
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Months to 54 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of DS from medical records.
- •Mental age (MA) of 18 months as measured on the Visual Reception subtest of the Mullen Scales of Early Learning.
- •Expressive vocabulary of fewer than 20 words at measured on a naturalistic language sample.
- •Age between 30 and 54 months
- •English or Spanish as the primary language at home.
- •Parents who are willing to participate in parent training.
Exclusion Criteria
- •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)
Arms & Interventions
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: Jasper-EMT with words and AAC (Behavioral)
Community treatment as usual
Children access educational and speech-language interventions available to them through schools and community resources.
Outcomes
Primary Outcomes
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 Outcomes
- Receptive language(up to 3 months)
- Executive Functioning(up to 3 months)
Investigators
Ann Kaiser
Susan W. Gray Professor of Education and Human Development
Vanderbilt University