Language ImpairmentMerckNCT02158390
Phenotypic Specific Communication Intervention for Children With Down Syndrome
A study testing Jasper-EMT with words and AAC in people with Language Impairment and Down Syndrome, run by Vanderbilt University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Impairment, Down Syndrome
- What is being tested?
- Jasper-EMT with words and AAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 6 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles Center for Autism Research and Treatment
Los Angeles, California, 90024
Vanderbilt University Kennedy Center
Nashville, Tennessee, 37203
About this study
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.
Read the 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
- Conditions
- Language Impairment, Down Syndrome
- Being tested
- Jasper-EMT with words and AAC
- Keywords
- Down syndrome, Language intervention, Communication intervention
- Medical subject headings
- Language Disorders, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jasper-EMT with words and AACBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (2)
Receptive language
Receptive language is assessed by child performance on the Preschool Language Scale 5th Edition ( PLS-5), a standardized language assessment.
Measured: up to 3 months
Executive Functioning
Children's executive functioning abilities will be assessed across a variety of tasks measuring persistence, planning, and attention.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion30 Aug 2017
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Ann Kaiser, Vanderbilt University
- Investigators
- Ann P Kaiser, PhD, Principal investigator, Vanderbilt UniversityConnie Kasari, PhD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158390
- Sponsor's protocol ID
- 05302014
- Acronym
- Merck
- Status last verified
- Jul 2018
- First submitted
- 4 Jun 2014
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This project does not require a data sharing plan. Results will be reported on profession journals.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Specific Communication Intervention for Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT02158390
- Acronym / sponsor ID
- Merck / 05302014
- Conditions
- Language Impairment, Down Syndrome
- Keywords
- Down syndrome, Language intervention, Communication intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jun 2014
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jasper-EMT with words and AAC | Experimental | Behavioral: Jasper-EMT with words and AACJasper-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. |
| Community treatment as usual | No intervention | –Children access educational and speech-language interventions available to them through schools and community resources. |
Who may qualify
- Ages
- 30 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jasper-EMT with words and AACJasper-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. | Behavioural | Jasper-EMT with words and AAC |
Primary outcome
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.
2 secondary outcomes
Receptive language
Time frame: up to 3 months
Executive Functioning
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No. This project does not require a data sharing plan. Results will be reported on profession journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann P Kaiser, PhD principal investigator
Vanderbilt University
Connie Kasari, PhD study director
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jasper-EMT with words and AAC in people with Language Impairment and Down Syndrome, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spoken language (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.