- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158390
Phenotypic Specific Communication Intervention for Children With Down Syndrome (Merck)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- University of California, Los Angeles Center for Autism Research and Treatment
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University Kennedy Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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. |
NO_INTERVENTION: Community treatment as usual
Children access educational and speech-language interventions available to them through schools and community resources.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receptive language
Time Frame: up to 3 months
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Receptive language is assessed by child performance on the Preschool Language Scale 5th Edition ( PLS-5), a standardized language assessment.
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up to 3 months
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Executive Functioning
Time Frame: up to 3 months
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Children's executive functioning abilities will be assessed across a variety of tasks measuring persistence, planning, and attention.
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up to 3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent use of Joint Attention Symbolic Play Engagement and Regulation- Enhanced Milieu Teaching ( Jasper-EMT) strategies
Time Frame: up to 3 months
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Observations of parent-child interactions are coded to determine parent use of key intervention strategies.
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up to 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Connie Kasari, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05302014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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