Clinical trial NCT03152383: Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism
Official title: Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Autism Spectrum Disorder
Behavioral Research
Psychology
Cognitive Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-15
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with autism, typically developing children, and children with developmental disabilities will participate in the same intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare how children with autism, typically developing children, and children with other developmental delays value social attention and toys. The first part of the study seeks to determine whether breakpoints when responding on progressive ratio (PR) schedules can be used to determine the value of leisure items and attention. By comparing the breakpoints obtained for leisure items and attention, the researchers will determine the differential valuation of leisure items and attention. It is anticipated that the manner in which individuals with an autism spectrum disorder (ASD) diagnosis and those who do not will differ with respect to the degree to which they value these two types of stimuli. The second part of the study seeks to determine whether an intervention in which social attention is paired with primary reinforcers impacts responding during the PR assessment, in children with ASD.

Detailed description: The three core features of autism spectrum disorder (ASD) are impairments in social interaction, restricted range of interest, and stereotyped/repetitive behavior. However, autism is a heterogeneous disorder, and individuals with a diagnosis vary widely in specific presentation. For example, despite an overall impairment in social behavior, some individuals with an autism diagnosis still frequently initiate social interactions with others. In contrast, others may engage in problem behaviors maintained by escape or avoidance of social interactions.

A progressive ratio (PR) assessment is one method for directly quantifying the degree to which an individual values a particular stimulus or event. Within a PR assessment, reinforcement occurs under schedule requirements that increase following each set of responses within a single session until responding ceases. The highest schedule requirement completed (i.e., breakpoint) can then be used as a measure of how much an individual is willing to respond for a given stimulus.

The study will include about 65 children, 25 children with ASD and 15 typically developing children, and 25 children with developmental disabilities other than ASD. Children with autism, typically developing children, and children with non-ASD developmental delays other than ASD will be compared in terms of how they value social attention and toys. The child participants will be asked to do an action, such as pressing a button, to receive either an item or attention. At first, the participants will only be required to do the action once, but after the first time the children will be required do more and more before they can get the item or attention. Eventually, most children stop responding for the preferred item or attention. The study will consider the child as done working when they go for one minute without performing the action. Sessions will end after 30 minutes if the child keeps working without stopping. This study will examine how many times the child will respond for items and attention. 15 of the children with ASD will be asked to come back for an additional appointment one week after they complete the assessment of how they value attention and toys. The PR assessment will be repeated see if the children respond the same way at different times.

The second part of the study will include 10 children diagnosed with ASD ranging in age from two to six. All of the procedures described in part one of the study will be included. The PR assessment will be completed prior to intervention and again after intervention. All appointments will be conducted over a maximum of 4 weeks. The intervention will be based on the principals of respondent conditioning; social interaction will be paired with the delivery of other reinforcers, such as edible items, to increase the value of social interaction. Sessions will be conducted 5 days per week and will be up to two hours long. Following the intervention, the participant will repeat the PR assessment in order to assess whether the intervention increased the value of social interaction.

Eligibility criteria: Inclusion Criteria for Autism Spectrum Disorder (ASD) Group:

* Between the ages of 3 and 6.
* Presence of an autism diagnosis as determined by The Autism Diagnostic Observation Schedule (ADOS).
* Adaptive functioning typical of autism as determined by the Vineland Adaptive Behavior Scales (VABS-II; survey interview form).
* Completion of the Social Responsiveness Scale (SRS) to assess social impairment.
* Completion of the Early Social Communication Scales to assess non-verbal communication.

Inclusion Criteria for Typically Developing Group:

* Between the ages of 3 and 6.
* Current developmental level determined to be not developmentally delayed per The Mullen Scales of Early Learning (MSEL) or Differential Ability Scale (DAS; depending on participant age).

Inclusion Criteria for Other Developmental Delays Group:

* Between the ages of 3 and 6.
* Current developmental level determined to be developmentally delayed per The Mullen Scales of Early Learning (MSEL) or Differential Ability Scale (DAS; depending on participant age).

Exclusion Criteria for all groups:

* Caregiver does not give permission for protective procedures and emergency protocols to be used if the child participant exhibits problem behaviors during a study visit.
* Children who are not able to master the training trial within 10 sessions will not participate in the study.

Primary outcomes:
measure: Breakpoint achieved for each stimulus
timeFrame: Up to one week
measure: Change in breakpoints
timeFrame: Assessment 1 through repeat assessment (up to 4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Nathan A Call, PhD
role: PRINCIPAL_INVESTIGATOR
References: