Stimulus-Stimulus Pairing Study

NCT ID: NCT02464527

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulus-stimulus pairing (SSP)

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.

Group Type: EXPERIMENTAL

Stimulus-stimulus pairing

Intervention Type: BEHAVIORAL

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 recorder

Intervention Type: OTHER

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.

Waitlist Control (Delayed Treatment)

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.

Group Type: ACTIVE_COMPARATOR

Stimulus-stimulus pairing

Intervention Type: BEHAVIORAL

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 recorder

Intervention Type: OTHER

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.

Interventions

Stimulus-stimulus pairing

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: BEHAVIORAL

Vocal recorder

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 47 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Alice Shillingsburg

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice Shillingsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Marcus Autism Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00073588

Identifier Type: -

Identifier Source: org_study_id