Autism Spectrum DisorderNCT02291172
Comprehensive Communication Intervention for Minimally Verbal Children With Autism
A study testing Intervention JEP in people with Autism Spectrum Disorder, run by Vanderbilt University at 1 site in United States.
Trial summary
Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children with Autism is to conduct an efficacy study of a promising intervention to increase spoken language in preschool children who are minimally verbal. Read more about this study
- Who is it for?
- Ages 36 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Intervention JEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 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 36 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A diagnosis of ASD as confirmed by the ADOS
- Mental age (MA) of 18 months as measured on the Mullen Scales of Early Learning
- Expressive vocabulary of less than 10
- Age between 36 and 54 month
- English as the primary language spoken at home
- Parents who are willing to participate in parent training.
Who cannot join
- Exclusion criteria include any major medical conditions other than ASD, specifically a genetic disorders such as Down syndrome
- Sensory disabilities such as blindness or deafness
- Motor disabilities such as cerebral palsy.
Trial locations and contacts
1 site in 1 country.
About this study
Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children with Autism is to conduct an efficacy study of a promising intervention to increase spoken language in preschool children who are minimally verbal. The proposed study compares a comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU) control group in a randomized controlled trial (RCT) across 4 time points. The study replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully promote social communication in older minimally verbal children. Intervention components include: (1) Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP- EMT), (2) applied with systematic parent training, (3) use of speech generating device (SGD) and (4) supplementary direct teaching of foundational skills for language learning as indicated by child entry skills (CORE-DTT; Smith, 2009). Children who remain minimally verbal beyond age 5 are at high risk for persistent, severe communication deficits that impact social development, educational achievement and quality of life (Tager-Flusberg \& Kasari, 2013). Thus, there is an urgent need for effective strategies to promote communication development during the preschool years to ameliorate early communication deficits and prevent persistent minimally verbal status. This study aims to change social communication in minimally verbal preschool children with ASD by applying a naturalistic social communication intervention which teaches the social foundations of communication and functional use of verbal language in play and interaction. In addition, the intervention addresses three factors that may contribute to remaining minimally verbal: lack of an effective mode of speech production, lack of foundational skills for learning language (receptive language, imitation, joint attention), and lack of communication partners to support continued language learning in natural environments.
Read the detailed description
The proposed project is a randomized control design study testing the effectiveness of a comprehensive communication intervention to improve spoken language and social communication, and to reduce the portion of children with autism who are minimally verbal at age 5. The intervention (JASP-EMT-Plus; JEP) includes four components which have been shown to be effective in improving outcomes for older children with ASD who are minimally verbal. These components are (a) direct teaching for foundational language skills, (b) systematic introduction of an SGD paired with spoken language; (c) A naturalistic communication intervention: Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP-EMT); and (d) parent training to support and generalize newly learned communication skills.
Following comprehensive assessment linking children's extant communication skills to the skills taught in each intervention component, an adapted treatment protocol will be developed for each child within the framework of the comprehensive treatment model. A total of 97 children ages 36 to 54 months will be randomly assigned to the treatment or a BAU control group. Progress in treatment will be monitored throughout the 3-month (42 session) intervention. Children will be assessed at 4 time points: pre intervention, post- intervention, 2 months, and 4 months after intervention. The data collected in this randomized trial will provide: (1) evidence of effectiveness for a comprehensive communicative intervention for improving communication in minimally verbal children with autism; and (2) new information about the correlates of minimal verbal status in children with autism.
Aim. To examine the effects of JEP on social communication (primary outcome) RQ1: Do young children with ASD who receive JEP produce significantly more social communicative utterances (proximal) in language samples, social communication on standardized assessment (distal), and expressive language on standardized assessment (distal) than children in the BAU group at T2 (immediately following intervention)?
- Conditions
- Autism Spectrum Disorder
- Being tested
- Intervention JEP
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention JEPBehavioural
A blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry.
| Study group | Role | What they receive |
|---|---|---|
| Intervention JEP | Experimental | A blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry. The comprehensive communication intervention: (a) teaches foundational social communicative behaviors, (b) related skills that predict long term language outcomes, (c) a range of communicative functions, (d) spoken language skills, (e) provides children with an immediate mode of communication, (f) incorporates instructional methods, contexts, and partners that increase both the critical skills for spoken language and social use of language. Because parents are essential partners for young children with ASD who are learning to communicate, we (g) include parents Receives: Behavioral: Intervention JEP |
| Business as Usual Control Group | No intervention | All children, regardless of group assignment will participate in all assessments. Children randomized to the control group will not receive intervention, but will complete all other research procedures. Other treatments that all children receive in the community will be recorded with bi-monthly surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous communicative utterances
measured from a naturalistic language sample
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Kaiser, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291172
- Sponsor's protocol ID
- 141453
- Status last verified
- Jul 2018
- First submitted
- 6 Nov 2014
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hampton LH, Kaiser AP, Fuller EA. Multi-component communication intervention for children with autism: A randomized controlled trial. Autism. 2020 Nov;24(8):2104-2116. doi: 10.1177/1362361320934558. Epub 2020 Jul 6.
PubMed 32627570
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
- Comprehensive Communication Intervention for Minimally Verbal Children With Autism
- ClinicalTrials.gov ID
- NCT02291172
- Acronym / sponsor ID
- 141453
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Nov 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.
Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children with Autism is to conduct an efficacy study of a promising intervention to increase spoken language in preschool children who are minimally verbal. The proposed study compares a comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU) control group in a randomized controlled trial (RCT) across 4 time points. The study replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully promote social communication in older minimally verbal children. Intervention components include: (1) Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP- EMT), (2) applied with systematic parent training, (3) use of speech generating device (SGD) and (4) supplementary direct teaching of foundational skills for language learning as indicated by child entry skills (CORE-DTT; Smith, 2009). Children who remain minimally verbal beyond age 5 are at high risk for persistent, severe communication deficits that impact social development, educational achievement and quality of life (Tager-Flusberg \& Kasari, 2013). Thus, there is an urgent need for effective strategies to promote communication development during the preschool years to ameliorate early communication deficits and prevent persistent minimally verbal status. This study aims to change social communication in minimally verbal preschool children with ASD by applying a naturalistic social communication intervention which teaches the social foundations of communication and functional use of verbal language in play and interaction. In addition, the intervention addresses three factors that may contribute to remaining minimally verbal: lack of an effective mode of speech production, lack of foundational skills for learning language (receptive language, imitation, joint attention), and lack of communication partners to support continued language learning in natural environments.
Detailed description
The proposed project is a randomized control design study testing the effectiveness of a comprehensive communication intervention to improve spoken language and social communication, and to reduce the portion of children with autism who are minimally verbal at age 5. The intervention (JASP-EMT-Plus; JEP) includes four components which have been shown to be effective in improving outcomes for older children with ASD who are minimally verbal. These components are (a) direct teaching for foundational language skills, (b) systematic introduction of an SGD paired with spoken language; (c) A naturalistic communication intervention: Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP-EMT); and (d) parent training to support and generalize newly learned communication skills.
Following comprehensive assessment linking children's extant communication skills to the skills taught in each intervention component, an adapted treatment protocol will be developed for each child within the framework of the comprehensive treatment model. A total of 97 children ages 36 to 54 months will be randomly assigned to the treatment or a BAU control group. Progress in treatment will be monitored throughout the 3-month (42 session) intervention. Children will be assessed at 4 time points: pre intervention, post- intervention, 2 months, and 4 months after intervention. The data collected in this randomized trial will provide: (1) evidence of effectiveness for a comprehensive communicative intervention for improving communication in minimally verbal children with autism; and (2) new information about the correlates of minimal verbal status in children with autism.
Aim. To examine the effects of JEP on social communication (primary outcome) RQ1: Do young children with ASD who receive JEP produce significantly more social communicative utterances (proximal) in language samples, social communication on standardized assessment (distal), and expressive language on standardized assessment (distal) than children in the BAU group at T2 (immediately following intervention)?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention JEP | Experimental | Behavioral: Intervention JEPA blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry. The comprehensive communication intervention: (a) teaches foundational social communicative behaviors, (b) related skills that predict long term language outcomes, (c) a range of communicative functions, (d) spoken language skills, (e) provides children with an immediate mode of communication, (f) incorporates instructional methods, contexts, and partners that increase both the critical skills for spoken language and social use of language. Because parents are essential partners for young children with ASD who are learning to communicate, we (g) include parents |
| Business as Usual Control Group | No intervention | –All children, regardless of group assignment will participate in all assessments. Children randomized to the control group will not receive intervention, but will complete all other research procedures. Other treatments that all children receive in the community will be recorded with bi-monthly surveys. |
Who may qualify
- Ages
- 36 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A diagnosis of ASD as confirmed by the ADOS
- Mental age (MA) of 18 months as measured on the Mullen Scales of Early Learning
- Expressive vocabulary of less than 10
- Age between 36 and 54 month
- English as the primary language spoken at home
Key exclusion criteria (3 listed)
- Exclusion criteria include any major medical conditions other than ASD, specifically a genetic disorders such as Down syndrome
- Sensory disabilities such as blindness or deafness
- Motor disabilities such as 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 |
|---|---|---|
| Intervention JEPA blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry. | Behavioural | Intervention JEP |
Primary outcome
Spontaneous communicative utterances
Time frame: 12 weeks
measured from a naturalistic language sample
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.
- Derived from this study: PubMed 32627570Hampton LH, Kaiser AP, Fuller EA. Multi-component communication intervention for children with autism: A randomized controlled trial. Autism. 2020 Nov;24(8):2104-2116. doi: 10.1177/1362361320934558. Epub 2020 Jul 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention JEP in people with Autism Spectrum Disorder, run by Vanderbilt University at 1 site 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 3 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 1 site 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?
Spontaneous communicative utterances (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291172, which also lists 1 linked publication.
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.