Autism Spectrum DisorderNCT02555241
Emergence of Generative Language
A study testing Mand Training, Matrix and Stimulus Equivalence Training in people with Autism Spectrum Disorder, run by Emory University.
Trial summary
The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mand Training, Matrix and Stimulus Equivalence Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2016
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder (ASD)
- Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
- Speaks primarily in one word utterances
- English as their primary language
- Follows simple 1-step instructions
- Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks
Who cannot join
- Children with significant problem behavior that interferes with structured intervention
About this study
Official title: Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder
The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mand Training, Matrix, Stimulus Equivalence Training
- Keywords
- ASD, Children
- 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.
Mand TrainingBehavioural
The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
MatrixBehavioural
The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
Stimulus Equivalence TrainingBehavioural
The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
| Study group | Role | What they receive |
|---|---|---|
| One Baseline Session | Experimental | Designated for participants #1 and #2. Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. Receives: Behavioral: Mand Training; Behavioral: Matrix; Behavioral: Stimulus Equivalence Training |
| Two Baseline Sessions | Experimental | Designated for participants #3 and #4. Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. Receives: Behavioral: Mand Training; Behavioral: Matrix; Behavioral: Stimulus Equivalence Training |
| Three Baseline Sessions | Experimental | Designated for participants #5 and #6. Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. Receives: Behavioral: Mand Training; Behavioral: Matrix; Behavioral: Stimulus Equivalence Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Length of Utterances (MLU) during manding
The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe. The goal of intervention is to increase of MLU to an average of 3 words per mand.
Measured: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Acquisition of noun-verb and color-shape combinations during tacting
The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.
Measured: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Emergence of intraverbal responses
The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).
Measured: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Secondary outcomes (2)
Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
The Macarthur Bates-Communicative Development Inventory (CDI) is completed by a parent/caregiver and evaluates current word use . A higher score indicates the use of more words.
Measured: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
A goal of the intervention is to observe an increase in spontaneous mands, an increase in spontaneous tacts, as well as an increase in intraverbal responses.
Measured: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Shillingsburg, Emory University
- Investigators
- Alice Shillingsburg, Principal investigator, Emory University Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555241
- Sponsor's protocol ID
- IRB00080641
- Status last verified
- Dec 2016
- First submitted
- 17 Sep 2015
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02555241
- Acronym / sponsor ID
- IRB00080641
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Sep 2015 (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.
The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One Baseline Session | Experimental | Behavioral: Mand Training, Behavioral: Matrix, Behavioral: Stimulus Equivalence TrainingDesignated for participants #1 and #2. Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. |
| Two Baseline Sessions | Experimental | Behavioral: Mand Training, Behavioral: Matrix, Behavioral: Stimulus Equivalence TrainingDesignated for participants #3 and #4. Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. |
| Three Baseline Sessions | Experimental | Behavioral: Mand Training, Behavioral: Matrix, Behavioral: Stimulus Equivalence TrainingDesignated for participants #5 and #6. Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of Autism Spectrum Disorder (ASD)
- Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
- Speaks primarily in one word utterances
- English as their primary language
- Follows simple 1-step instructions
Key exclusion criteria (1 listed)
- Children with significant problem behavior that interferes with structured intervention
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 |
|---|---|---|
| Mand TrainingThe mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding. | Behavioural | One Baseline Session, Three Baseline Sessions, Two Baseline Sessions |
| MatrixThe matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training. | Behavioural | One Baseline Session, Three Baseline Sessions, Two Baseline Sessions |
| Stimulus Equivalence TrainingThe stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills. | Behavioural | One Baseline Session, Three Baseline Sessions, Two Baseline Sessions |
Primary outcome
Change in Mean Length of Utterances (MLU) during manding
Time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe. The goal of intervention is to increase of MLU to an average of 3 words per mand.
Acquisition of noun-verb and color-shape combinations during tacting
Time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.
Emergence of intraverbal responses
Time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).
2 secondary outcomes
Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
Time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
Time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
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 5 Dec 2016.
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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.
Alice Shillingsburg principal investigator
Emory University Assistant Professor
Questions about this trial
What is this clinical trial studying?
A study testing Mand Training, Matrix and Stimulus Equivalence Training in people with Autism Spectrum Disorder, run by Emory University.
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 1 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Mean Length of Utterances (MLU) during manding (time frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)). The study lists 3 primary outcomes in all. 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 5 Dec 2016.