AutismAIM-ASDNCT01751698
Adaptive Interventions for Minimally Verbal Children With ASD in the Community
A study testing JASP-EMT and DTT in people with Autism, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT and CORE- DTT) that have shown promise for optimizing the number of unique socially communicative and spontaneously spoken words in… Read more about this study
- Who is it for?
- Ages 54 to 96 months
- Conditions the study is for
- Autism
- What is being tested?
- JASP-EMT and DTT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Dec 2017
- 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 54 to 96 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of autism
- At least 4 years, 6 months old, and not older than 8 years, 0 months
- Displays less than 20 spontaneous, unique, and socially communicative words during screening assessments
- At least 18 months developmental age
- Currently in school
Who cannot join
- Diagnosis of syndrome or degenerative disorder
- Poorly controlled seizures
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of California, Los Angeles
Los Angeles, California, 90024
Vanderbilt University
Nashville, Tennessee, 37203
University of Rochester
Rochester, New York, 14642
Weill Cornell Medical College
White Plains, New York, 10605
About this study
Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT and CORE- DTT) that have shown promise for optimizing the number of unique socially communicative and spontaneously spoken words in minimally verbal children with ASD. The study utilizes a novel sequential multiple assignment-randomized trial to evaluate and construct an optimal adaptive intervention. A total of 192 minimally verbal school aged children with an Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across four sites, University of California Los Angeles, University of Rochester, Vanderbilt University and Weill Cornell Medical Center with methodological and statistical support from University of Michigan.
Read the detailed description
Interventions:
- CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field. The participants in the proposed study will have had at least 1 year of previous intervention, likely in an ABA program with DTT as a main strategy. While many children will have been exposed to DTT prior to entering this trial, it is important to insure that children (a) receive quality DTT, and (b) have exposure to CORE elements related to language learning, specifically joint attention and requesting gestures, in order to make the comparison with JASP-EMT.
- JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers. For minimally verbal children with autism, meaningful social interaction is essential for establishing the platform on which language input and development will be built.
- Conditions
- Autism
- Being tested
- JASP-EMT, DTT
- Keywords
- Autism, Minimally Verbal, School Age
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASP-EMTBehavioural
JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers.
DTTBehavioural
CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field.
| Study group | Role | What they receive |
|---|---|---|
| JASP-EMT | Active comparator | JASP-EMT (Joint Attention, Symbolic Play and Enhanced Milieu Teaching) focuses on creating a context for joint engagement within naturally occurring child-led play routines. There is evidence of the effects of these interventions with children with ASD, and pilot data showing effects with minimally verbal children. Receives: Behavioral: JASP-EMT |
| DTT | Active comparator | CORE-DTT (discrete trial training for core features of ASD) emphasizes didactic adult-led instruction and is considered the current evidenced-based 'standard of care' for children with autism (NRC, 2001). Receives: Behavioral: DTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1: Language Sample
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).
Measured: Follow-Up; 8 months on average
Secondary outcomes (3)
Secondary Aim 1: Joint Engagement
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in symbol-infused joint engagement.
Measured: Follow-Up; 8 months on average
Secondary Outcome 2: Number of Unique Words (Vocabulary)
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in number of unique words.
Measured: Follow-Up; 8 months on average
Secondary Outcome 3: Object Play
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in object play level.
Measured: Follow-Up; 8 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
- Investigators
- Connie Kasari, PhD, Principal investigator, University of California, Los AngelesAnn Kaiser, PhD, Principal investigator, Vanderbilt UniversityTristram Smith, PhD, Principal investigator, University of RochesterCatherine Lord, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751698
- Sponsor's protocol ID
- R01HD073975
- Other IDs
- R01HD073975
- Acronym
- AIM-ASD
- Status last verified
- Jun 2024
- First submitted
- 14 Dec 2012
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kasari C, Paparella T, Freeman S, Jahromi LB. Language outcome in autism: randomized comparison of joint attention and play interventions. J Consult Clin Psychol. 2008 Feb;76(1):125-37. doi: 10.1037/0022-006X.76.1.125.
PubMed 18229990Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.
PubMed 16712638Kaiser AP, Roberts MY. Parent-implemented enhanced milieu teaching with preschool children who have intellectual disabilities. J Speech Lang Hear Res. 2013 Feb;56(1):295-309. doi: 10.1044/1092-4388(2012/11-0231). Epub 2012 Jun 28.
PubMed 22744141Roberts MY, Kaiser AP. Assessing the effects of a parent-implemented language intervention for children with language impairments using empirical benchmarks: a pilot study. J Speech Lang Hear Res. 2012 Dec;55(6):1655-70. doi: 10.1044/1092-4388(2012/11-0236). Epub 2012 Apr 5.
PubMed 22490620Smith T, Scahill L, Dawson G, Guthrie D, Lord C, Odom S, Rogers S, Wagner A. Designing research studies on psychosocial interventions in autism. J Autism Dev Disord. 2007 Feb;37(2):354-66. doi: 10.1007/s10803-006-0173-3.
PubMed 16897380Lord C, Wagner A, Rogers S, Szatmari P, Aman M, Charman T, Dawson G, Durand VM, Grossman L, Guthrie D, Harris S, Kasari C, Marcus L, Murphy S, Odom S, Pickles A, Scahill L, Shaw E, Siegel B, Sigman M, Stone W, Smith T, Yoder P. Challenges in evaluating psychosocial interventions for Autistic Spectrum Disorders. J Autism Dev Disord. 2005 Dec;35(6):695-708; discussion 709-11. doi: 10.1007/s10803-005-0017-6.
PubMed 16496206Pickett E, Pullara O, O'Grady J, Gordon B. Speech acquisition in older nonverbal individuals with autism: a review of features, methods, and prognosis. Cogn Behav Neurol. 2009 Mar;22(1):1-21. doi: 10.1097/WNN.0b013e318190d185.
PubMed 19372766Kidwell KM, Seewald NJ, Tran Q, Kasari C, Almirall D. Design and Analysis Considerations for Comparing Dynamic Treatment Regimens with Binary Outcomes from Sequential Multiple Assignment Randomized Trials. J Appl Stat. 2018;45:1628-1651. doi: 10.1080/02664763.2017.1386773. Epub 2017 Oct 12.
PubMed 30555200Almirall D, Kasari C, McCaffrey DF, Nahum-Shani I. Developing Optimized Adaptive Interventions in Education. J Res Educ Eff. 2018;11(1):27-34. doi: 10.1080/19345747.2017.1407136. Epub 2017 Nov 29.
PubMed 29552270Lu X, Nahum-Shani I, Kasari C, Lynch KG, Oslin DW, Pelham WE, Fabiano G, Almirall D. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med. 2016 May 10;35(10):1595-615. doi: 10.1002/sim.6819. Epub 2015 Dec 6.
PubMed 26638988Kasari C. Update on behavioral interventions for autism and developmental disabilities. Curr Opin Neurol. 2015 Apr;28(2):124-9. doi: 10.1097/WCO.0000000000000185.
PubMed 25695136Kasari C, Shire S, Shih W, Landa R, Levato L, Smith T. Spoken language outcomes in limited language preschoolers with autism and global developmental delay: RCT of early intervention approaches. Autism Res. 2023 Jun;16(6):1236-1246. doi: 10.1002/aur.2932. Epub 2023 Apr 18.
PubMed 37070270Sterrett K, Holbrook A, Landa R, Kaiser A, Kasari C. The effect of responsiveness to speech-generating device input on spoken language in children with autism spectrum disorder who are minimally verbaldagger. Augment Altern Commun. 2023 Mar;39(1):23-32. doi: 10.1080/07434618.2022.2120070. Epub 2022 Oct 20.
PubMed 36267016Toolan C, Holbrook A, Schlink A, Shire S, Brady N, Kasari C. Using the Clinical Global Impression scale to assess social communication change in minimally verbal children with autism spectrum disorder. Autism Res. 2022 Feb;15(2):284-295. doi: 10.1002/aur.2638. Epub 2021 Nov 19.
PubMed 34800004Harrop C, Sterrett K, Shih W, Landa R, Kaiser A, Kasari C. Short-term trajectories of restricted and repetitive behaviors in minimally verbal children with autism spectrum disorder. Autism Res. 2021 Aug;14(8):1789-1799. doi: 10.1002/aur.2528. Epub 2021 May 7.
PubMed 33960125
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Interventions for Minimally Verbal Children With ASD in the Community
- ClinicalTrials.gov ID
- NCT01751698
- Acronym / sponsor ID
- AIM-ASD / R01HD073975
- Conditions
- Autism
- Keywords
- Autism, Minimally Verbal, School Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2012 (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.
Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT and CORE- DTT) that have shown promise for optimizing the number of unique socially communicative and spontaneously spoken words in minimally verbal children with ASD. The study utilizes a novel sequential multiple assignment-randomized trial to evaluate and construct an optimal adaptive intervention. A total of 192 minimally verbal school aged children with an Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across four sites, University of California Los Angeles, University of Rochester, Vanderbilt University and Weill Cornell Medical Center with methodological and statistical support from University of Michigan.
Detailed description
Interventions:
- CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field. The participants in the proposed study will have had at least 1 year of previous intervention, likely in an ABA program with DTT as a main strategy. While many children will have been exposed to DTT prior to entering this trial, it is important to insure that children (a) receive quality DTT, and (b) have exposure to CORE elements related to language learning, specifically joint attention and requesting gestures, in order to make the comparison with JASP-EMT.
- JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers. For minimally verbal children with autism, meaningful social interaction is essential for establishing the platform on which language input and development will be built.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JASP-EMT | Active comparator | Behavioral: JASP-EMTJASP-EMT (Joint Attention, Symbolic Play and Enhanced Milieu Teaching) focuses on creating a context for joint engagement within naturally occurring child-led play routines. There is evidence of the effects of these interventions with children with ASD, and pilot data showing effects with minimally verbal children. |
| DTT | Active comparator | Behavioral: DTTCORE-DTT (discrete trial training for core features of ASD) emphasizes didactic adult-led instruction and is considered the current evidenced-based 'standard of care' for children with autism (NRC, 2001). |
Who may qualify
- Ages
- 54 to 96 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of autism
- At least 4 years, 6 months old, and not older than 8 years, 0 months
- Displays less than 20 spontaneous, unique, and socially communicative words during screening assessments
- At least 18 months developmental age
- Currently in school
Key exclusion criteria (2 listed)
- Diagnosis of syndrome or degenerative disorder
- Poorly controlled seizures
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 |
|---|---|---|
| JASP-EMTJASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers. | Behavioural | JASP-EMT |
| DTTCORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field. | Behavioural | DTT |
Primary outcome
Primary Outcome 1: Language Sample
Time frame: Follow-Up; 8 months on average
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).
3 secondary outcomes
Secondary Aim 1: Joint Engagement
Time frame: Follow-Up; 8 months on average
Secondary Outcome 2: Number of Unique Words (Vocabulary)
Time frame: Follow-Up; 8 months on average
Secondary Outcome 3: Object Play
Time frame: Follow-Up; 8 months on average
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 14 Jun 2024.
- Background: PubMed 18229990Kasari C, Paparella T, Freeman S, Jahromi LB. Language outcome in autism: randomized comparison of joint attention and play interventions. J Consult Clin Psychol. 2008 Feb;76(1):125-37. doi: 10.1037/0022-006X.76.1.125.
- Background: PubMed 16712638Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.
- Background: PubMed 22744141Kaiser AP, Roberts MY. Parent-implemented enhanced milieu teaching with preschool children who have intellectual disabilities. J Speech Lang Hear Res. 2013 Feb;56(1):295-309. doi: 10.1044/1092-4388(2012/11-0231). Epub 2012 Jun 28.
- Background: PubMed 22490620Roberts MY, Kaiser AP. Assessing the effects of a parent-implemented language intervention for children with language impairments using empirical benchmarks: a pilot study. J Speech Lang Hear Res. 2012 Dec;55(6):1655-70. doi: 10.1044/1092-4388(2012/11-0236). Epub 2012 Apr 5.
- Background: PubMed 16897380Smith T, Scahill L, Dawson G, Guthrie D, Lord C, Odom S, Rogers S, Wagner A. Designing research studies on psychosocial interventions in autism. J Autism Dev Disord. 2007 Feb;37(2):354-66. doi: 10.1007/s10803-006-0173-3.
- Background: PubMed 16496206Lord C, Wagner A, Rogers S, Szatmari P, Aman M, Charman T, Dawson G, Durand VM, Grossman L, Guthrie D, Harris S, Kasari C, Marcus L, Murphy S, Odom S, Pickles A, Scahill L, Shaw E, Siegel B, Sigman M, Stone W, Smith T, Yoder P. Challenges in evaluating psychosocial interventions for Autistic Spectrum Disorders. J Autism Dev Disord. 2005 Dec;35(6):695-708; discussion 709-11. doi: 10.1007/s10803-005-0017-6.
- Background: PubMed 19372766Pickett E, Pullara O, O'Grady J, Gordon B. Speech acquisition in older nonverbal individuals with autism: a review of features, methods, and prognosis. Cogn Behav Neurol. 2009 Mar;22(1):1-21. doi: 10.1097/WNN.0b013e318190d185.
- Background: PubMed 30555200Kidwell KM, Seewald NJ, Tran Q, Kasari C, Almirall D. Design and Analysis Considerations for Comparing Dynamic Treatment Regimens with Binary Outcomes from Sequential Multiple Assignment Randomized Trials. J Appl Stat. 2018;45:1628-1651. doi: 10.1080/02664763.2017.1386773. Epub 2017 Oct 12.
- Background: PubMed 29552270Almirall D, Kasari C, McCaffrey DF, Nahum-Shani I. Developing Optimized Adaptive Interventions in Education. J Res Educ Eff. 2018;11(1):27-34. doi: 10.1080/19345747.2017.1407136. Epub 2017 Nov 29.
- Background: PubMed 26638988Lu X, Nahum-Shani I, Kasari C, Lynch KG, Oslin DW, Pelham WE, Fabiano G, Almirall D. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med. 2016 May 10;35(10):1595-615. doi: 10.1002/sim.6819. Epub 2015 Dec 6.
- Background: PubMed 25695136Kasari C. Update on behavioral interventions for autism and developmental disabilities. Curr Opin Neurol. 2015 Apr;28(2):124-9. doi: 10.1097/WCO.0000000000000185.
- Results publication: PubMed 37070270Kasari C, Shire S, Shih W, Landa R, Levato L, Smith T. Spoken language outcomes in limited language preschoolers with autism and global developmental delay: RCT of early intervention approaches. Autism Res. 2023 Jun;16(6):1236-1246. doi: 10.1002/aur.2932. Epub 2023 Apr 18.
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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.
Connie Kasari, PhD principal investigator
University of California, Los Angeles
Ann Kaiser, PhD principal investigator
Vanderbilt University
Tristram Smith, PhD principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASP-EMT and DTT in people with Autism, run by University of California, Los Angeles at 4 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 5 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Primary Outcome 1: Language Sample (time frame: Follow-Up; 8 months on average). 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 NCT01751698, which also lists 22 linked publications.
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 14 Jun 2024.