Autism Spectrum DisorderNCT02464527
Stimulus-Stimulus Pairing Study
A study testing Stimulus-stimulus pairing and Vocal recorder in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder. Read more about this study
- Who is it for?
- Ages 24 to 47 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Stimulus-stimulus pairing and Vocal recorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2015
- 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 24 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism
- Currently do not emit vocalizations or minimally verbal
- Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.
Who cannot join
- 1. Children with significant problem behavior that interferes with structured intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Study to Increase Vocal Language in Minimally Verbal Children Diagnosed With Autism Spectrum Disorders
The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.
Read the detailed description
The purpose of this study is to teach children with autism who do not produce sounds or words to vocalize sounds or words by using the stimulus-stimulus pairing (SSP) procedure. The investigators will use SSP, an intervention based in behavior analysis, to try to help the child vocalize sounds. A vocal recorder will also be sent home so that the caregiver can record the child's vocalization at home. The caregiver will then be asked to return this so that the investigators can listen to it. By doing this, the investigators hope to learn if the treatment helps increase the child's vocalizations at home. Some children in the study will receive treatment immediately. Some children may enroll in the study now but not receive intervention until a later date. All children in the study will receive treatment within one year of enrolling in the study.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Stimulus-stimulus pairing, Vocal recorder
- Keywords
- Stimulus-stimulus pairing
- 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.
Stimulus-stimulus pairingBehavioural
The participants will attend clinic-based treatment sessions for one hour per day, five days per week, for 6-weeks.The stimulus-stimulus pairing procedure will consist of sounds and words being systematically paired with delivery of a preferred item.
Vocal recorderOther
The vocal recorder is a voice recording device that enhances vocalization data. The parent/ guardian will be instructed on how to use the vocal recorder. The vocal recorder will then be deployed at the participant's homes via parent/guardian. The parent/guardian will record vocalizations for approximately 1 hour while in the home or community setting pre, mid, and post treatment. The parent/guardian will return the vocal recorder to the study team for analysis of the recordings.
| Study group | Role | What they receive |
|---|---|---|
| Stimulus-stimulus pairing (SSP) | Experimental | Minimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations, will be randomly assigned to the treatment group and will begin the stimulus-stimulus pairing (SSP) procedure. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting. Receives: Behavioral: Stimulus-stimulus pairing; Other: Vocal recorder |
| Waitlist Control (Delayed Treatment) | Active comparator | Minimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations will be randomly assigned to the Waitlist Control group. During the waitlist control subject's assigned session block of six weeks, s/he will not receive any treatment. The subjects will receive the stimulus-stimulus pairing procedure (delayed procedure) after the completion of the assigned 6-week block as a waitlist control participant. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting. Receives: Behavioral: Stimulus-stimulus pairing; Other: Vocal recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions
The therapist will pair echoic sounds and words with preferred items. A target vocalization is any vocal response that matches the paired sound or word. An approximation is any sound that is a component of the targeted word. A successful vocalization is when the participant emits the target or approximation of a targeted sound or word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.
Measured: Week 1, Week 6
Change in frequency of target vocalizations and/or approximations at home
Vocalization data will be collected in the home via the vocal recorder device. Target vocalization is when the participant emits the target sound or word. An approximation is any sound that is a component of the targeted word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.
Measured: Week 1, Week 6
Change in parent-reported vocalizations
A parent-rated checklist will assess their child's vocal language and parents will rate improvement as a yes or no question on the checklist at week 1 and week 6.
Measured: Week 1, Week 6
Feasibility of intervention assessed by reliability of delivery by therapists
The number of times stimulus-stimulus pairing (SSP) is reliably delivered by the therapist to the participant during the treatment period of 6 weeks will be assessed. Reliable delivery consists of the therapist pairing sounds and words with preferred items in accordance to the protocol.
Measured: Week 6
Acceptability of stimulus-stimulus pairing (SSP) by parents
The level of compliance and willingness of the parents/guardian to bring the subjects to the treatment sessions will be assessed. Acceptability is when the parent/guardian brings the subject to the clinic for the treatment sessions for one hour a day, five days per week, for 6 weeks.
Measured: Week 6
Secondary outcomes (2)
Feasibility of intervention assessed by compliance of the vocal recorder
The level of adherence of the parent/guardian of the participants in returning the recording device to allow the research team to extract the data collected will be recorded.
Measured: Week 6
Feasibility of the vocal recorder assessed by the utility of vocal recorder
The utility of the vocal recorder, a voice recording device, to enhance vocalization data and gather meaningful data by using the device in the homes of participants will be assessed.The enhancement of vocalization data recorded by the vocal recorder will also be assessed. The data recorded will be analyzed to determine if subject vocalizations were recorded accurately.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- 16 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, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464527
- Sponsor's protocol ID
- IRB00073588
- Status last verified
- Jul 2016
- First submitted
- 13 May 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study to Increase Vocal Language in Minimally Verbal Children Diagnosed With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02464527
- Acronym / sponsor ID
- IRB00073588
- Conditions
- Autism Spectrum Disorder
- Keywords
- Stimulus-stimulus pairing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Jun 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 the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.
Detailed description
The purpose of this study is to teach children with autism who do not produce sounds or words to vocalize sounds or words by using the stimulus-stimulus pairing (SSP) procedure. The investigators will use SSP, an intervention based in behavior analysis, to try to help the child vocalize sounds. A vocal recorder will also be sent home so that the caregiver can record the child's vocalization at home. The caregiver will then be asked to return this so that the investigators can listen to it. By doing this, the investigators hope to learn if the treatment helps increase the child's vocalizations at home. Some children in the study will receive treatment immediately. Some children may enroll in the study now but not receive intervention until a later date. All children in the study will receive treatment within one year of enrolling in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulus-stimulus pairing (SSP) | Experimental | Behavioral: Stimulus-stimulus pairing, Other: Vocal recorderMinimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations, will be randomly assigned to the treatment group and will begin the stimulus-stimulus pairing (SSP) procedure. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting. |
| Waitlist Control (Delayed Treatment) | Active comparator | Behavioral: Stimulus-stimulus pairing, Other: Vocal recorderMinimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations will be randomly assigned to the Waitlist Control group. During the waitlist control subject's assigned session block of six weeks, s/he will not receive any treatment. The subjects will receive the stimulus-stimulus pairing procedure (delayed procedure) after the completion of the assigned 6-week block as a waitlist control participant. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting. |
Who may qualify
- Ages
- 24 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of autism
- Currently do not emit vocalizations or minimally verbal
- Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.
Key exclusion criteria (1 listed)
- 1. 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 |
|---|---|---|
| Stimulus-stimulus pairingThe participants will attend clinic-based treatment sessions for one hour per day, five days per week, for 6-weeks.The stimulus-stimulus pairing procedure will consist of sounds and words being systematically paired with delivery of a preferred item. | Behavioural | Stimulus-stimulus pairing (SSP), Waitlist Control (Delayed Treatment) |
| Vocal recorderThe vocal recorder is a voice recording device that enhances vocalization data. The parent/ guardian will be instructed on how to use the vocal recorder. The vocal recorder will then be deployed at the participant's homes via parent/guardian. The parent/guardian will record vocalizations for approximately 1 hour while in the home or community setting pre, mid, and post treatment. The parent/guardian will return the vocal recorder to the study team for analysis of the recordings. | Other | Stimulus-stimulus pairing (SSP), Waitlist Control (Delayed Treatment) |
Primary outcome
Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions
Time frame: Week 1, Week 6
The therapist will pair echoic sounds and words with preferred items. A target vocalization is any vocal response that matches the paired sound or word. An approximation is any sound that is a component of the targeted word. A successful vocalization is when the participant emits the target or approximation of a targeted sound or word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.
Change in frequency of target vocalizations and/or approximations at home
Time frame: Week 1, Week 6
Vocalization data will be collected in the home via the vocal recorder device. Target vocalization is when the participant emits the target sound or word. An approximation is any sound that is a component of the targeted word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.
Change in parent-reported vocalizations
Time frame: Week 1, Week 6
A parent-rated checklist will assess their child's vocal language and parents will rate improvement as a yes or no question on the checklist at week 1 and week 6.
Feasibility of intervention assessed by reliability of delivery by therapists
Time frame: Week 6
The number of times stimulus-stimulus pairing (SSP) is reliably delivered by the therapist to the participant during the treatment period of 6 weeks will be assessed. Reliable delivery consists of the therapist pairing sounds and words with preferred items in accordance to the protocol.
Acceptability of stimulus-stimulus pairing (SSP) by parents
Time frame: Week 6
The level of compliance and willingness of the parents/guardian to bring the subjects to the treatment sessions will be assessed. Acceptability is when the parent/guardian brings the subject to the clinic for the treatment sessions for one hour a day, five days per week, for 6 weeks.
2 secondary outcomes
Feasibility of intervention assessed by compliance of the vocal recorder
Time frame: Week 6
Feasibility of the vocal recorder assessed by the utility of vocal recorder
Time frame: Week 6
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 15 Jul 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, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulus-stimulus pairing and Vocal recorder in people with Autism Spectrum Disorder, run by Emory 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 3 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 15 Jul 2016. 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?
Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions (time frame: Week 1, Week 6). The study lists 5 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 15 Jul 2016.