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Stimulus-Stimulus Pairing Study

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulus-stimulus pairing
Vocal recorder
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Stimulus-stimulus pairing

Eligibility Criteria

24 Months - 47 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of autism
  2. Currently do not emit vocalizations or minimally verbal
  3. 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.

Exclusion Criteria:

1. Children with significant problem behavior that interferes with structured intervention

Sites / Locations

  • Marcus Autism Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimulus-stimulus pairing (SSP)

Waitlist Control (Delayed Treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 13, 2015
Last Updated
July 13, 2016
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02464527
Brief Title
Stimulus-Stimulus Pairing Study
Official Title
A Pilot Feasibility Study to Increase Vocal Language in Minimally Verbal Children Diagnosed With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Stimulus-stimulus pairing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulus-stimulus pairing (SSP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control (Delayed Treatment)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stimulus-stimulus pairing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vocal recorder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions
Description
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.
Time Frame
Week 1, Week 6
Title
Change in frequency of target vocalizations and/or approximations at home
Description
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.
Time Frame
Week 1, Week 6
Title
Change in parent-reported vocalizations
Description
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.
Time Frame
Week 1, Week 6
Title
Feasibility of intervention assessed by reliability of delivery by therapists
Description
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.
Time Frame
Week 6
Title
Acceptability of stimulus-stimulus pairing (SSP) by parents
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Feasibility of intervention assessed by compliance of the vocal recorder
Description
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.
Time Frame
Week 6
Title
Feasibility of the vocal recorder assessed by the utility of vocal recorder
Description
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.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Children with significant problem behavior that interferes with structured intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Shillingsburg, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcus Autism Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

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Stimulus-Stimulus Pairing Study

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