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Completed

NCT Number: NCT02464527

Stimulus-Stimulus Pairing Study

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

24 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcus Autism Center

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Children with significant problem behavior that interferes with structured intervention

Treatment and study plan

Stimulus-stimulus pairing

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Feasibility of intervention assessed by compliance of the vocal recorder

    Time frame: Week 6

    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.

  2. Feasibility of the vocal recorder assessed by the utility of vocal recorder

    Time frame: Week 6

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

A Pilot Feasibility Study to Increase Vocal Language in Minimally Verbal Children Diagnosed With Autism Spectrum Disorders

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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