Phenotypic Specific Communication Intervention for Children With Down Syndrome

NCT02158390 | Completed DMC

• 1 other identifier: 05302014
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Language Impairment; Down Syndrome

Keywords

Down syndrome; Language intervention; Communication intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Receptive language

  up to 3 months

• Executive Functioning

  up to 3 months

Other Outcomes (1)

• Parent use of Joint Attention Symbolic Play Engagement and Regulation- Enhanced Milieu Teaching ( Jasper-EMT) strategies

  up to 3 months

Study Arms (2)

Jasper-EMT with words and AAC

EXPERIMENTAL

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

Community treatment as usual

NO INTERVENTION

Children access educational and speech-language interventions available to them through schools and community resources.

Interventions

Jasper-EMT with words and AAC BEHAVIORAL

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.

Jasper-EMT with words and AAC

Eligibility Criteria

• Age: 30 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Vanderbilt University: lead
• University of California, Los Angeles: collaborator

Study Sites (2)

University of California, Los Angeles Center for Autism Research and Treatment

Los Angeles, California, 90024, United States

Location

Vanderbilt University Kennedy Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Language Disorders; Down Syndrome

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Ann P Kaiser, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Connie Kasari, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Susan W. Gray Professor of Education and Human Development

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: August 30, 2017
• Study Completion: February 6, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)