AutismNCT03152383
Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism
A study testing Training trials, Progressive Ratio Session and Re-test in people with Autism, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism
- What is being tested?
- Training trials, Progressive Ratio Session and Re-test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2012to 31 Dec 2020
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Training trials, Progressive Ratio Session, Re-test, Pairing Protocol
- Keywords
- Autism Spectrum Disorder, Behavioral Research, Psychology, Cognitive Disorders
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training trialsBehavioural
A highly preferred edible item will be selected to teach the contingencies for the assessment. Materials to engage in the work response (i.e., button press) will be placed within arm's reach of the child, and the edible item will be in sight. The therapist will deliver a vocal prompt for the child to engage in the work response (e.g., "press the button and you can have some candy"). If the child engages in the response, the therapist immediately delivers the edible item. The therapist will guide the child to engage in the instrumental response, and will then gradually begin to fade the prompt level. If the child makes an error at any level of prompting, the therapist will guide the participant to emit a correct response. The edible item will be delivered to the child each time that the child responds correctly at any prompt level.
Progressive Ratio SessionBehavioural
The child will be guided to engage in the instrumental response then the stimulus will be immediately delivered for 30 seconds. The leisure item or the individual who will provide attention will be directly outside of the session room. If the child emits the work response, they will be allowed access to either a leisure item or to attention (depending on the condition) for 30 seconds. The child is initially required to respond one time, then they will be required to respond two times to gain access to the item or attention (then 4, then 8, and so on) such that the response requirement progressively increases according to a pre-determined schedule. A minimum of 3 sessions will be conducted for each condition. The amount of time required for participation depends on the child's responding, and caregiver availability. Participation may take as little as a couple hours, or as long as 3-4 hours per day for approximately one week.
Re-testBehavioural
10 children with ASD will return to repeat the progressive ratio (PR) assessment one week after completing it the first time to examine the reliability of the measure.
Pairing ProtocolBehavioural
15 children with ASD will receive an intervention designed to increase social approach after completing the PR assessment. Participants will attend 2 hour appointments 3-5 days per week in which a therapist will deliver highly preferred items, play with the child, work on teaching communication skills, and teach the child to comply with demands. After completing the intervention (once the child is willingly staying near and interacting with the therapist and complying with instructions), the PR assessment will be repeated to measure change due to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Children diagnosed as having autism spectrum disorder Receives: Behavioral: Training trials; Behavioral: Progressive Ratio Session; Behavioral: Re-test; Behavioral: Pairing Protocol |
| Typically developing | Active comparator | Children who are typically developing Receives: Behavioral: Training trials; Behavioral: Progressive Ratio Session |
| Other Developmental Delay | Active comparator | Children diagnosed with a developmental delay other than autism spectrum disorder Receives: Behavioral: Training trials; Behavioral: Progressive Ratio Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breakpoint achieved for each stimulus
The highest schedule requirement completed (i.e., breakpoint) is used as a measure of how much an individual is willing to respond for a given stimulus.
Measured: Up to one week
Change in breakpoints
For children receiving the intervention the change between breakpoints across the two PR assessments conducted before and after intervention will be examined.
Measured: Assessment 1 through repeat assessment (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start22 Jun 2012
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Children with autism, typically developing children, and children with developmental disabilities will participate in the same intervention.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nathan A. Call, Emory University
- Investigators
- Nathan A Call, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152383
- Sponsor's protocol ID
- IRB00056563
- Other IDs
- R21MH108873
- Status last verified
- May 2023
- First submitted
- 11 May 2017
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism
- ClinicalTrials.gov ID
- NCT03152383
- Acronym / sponsor ID
- IRB00056563
- Conditions
- Autism
- Keywords
- Autism Spectrum Disorder, Behavioral Research, Psychology, Cognitive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Jun 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 May 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Children with autism, typically developing children, and children with developmental disabilities will participate in the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Behavioral: Training trials, Behavioral: Progressive Ratio Session, Behavioral: Re-test, Behavioral: Pairing ProtocolChildren diagnosed as having autism spectrum disorder |
| Typically developing | Active comparator | Behavioral: Training trials, Behavioral: Progressive Ratio SessionChildren who are typically developing |
| Other Developmental Delay | Active comparator | Behavioral: Training trials, Behavioral: Progressive Ratio SessionChildren diagnosed with a developmental delay other than autism spectrum disorder |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
- 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).
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Training trialsA highly preferred edible item will be selected to teach the contingencies for the assessment. Materials to engage in the work response (i.e., button press) will be placed within arm's reach of the child, and the edible item will be in sight. The therapist will deliver a vocal prompt for the child to engage in the work response (e.g., "press the button and you can have some candy"). If the child engages in the response, the therapist immediately delivers the edible item. The therapist will guide the child to engage in the instrumental response, and will then gradually begin to fade the prompt level. If the child makes an error at any level of prompting, the therapist will guide the participant to emit a correct response. The edible item will be delivered to the child each time that the child responds correctly at any prompt level. | Behavioural | Autism Spectrum Disorder, Other Developmental Delay, Typically developing |
| Progressive Ratio SessionThe child will be guided to engage in the instrumental response then the stimulus will be immediately delivered for 30 seconds. The leisure item or the individual who will provide attention will be directly outside of the session room. If the child emits the work response, they will be allowed access to either a leisure item or to attention (depending on the condition) for 30 seconds. The child is initially required to respond one time, then they will be required to respond two times to gain access to the item or attention (then 4, then 8, and so on) such that the response requirement progressively increases according to a pre-determined schedule. A minimum of 3 sessions will be conducted for each condition. The amount of time required for participation depends on the child's responding, and caregiver availability. Participation may take as little as a couple hours, or as long as 3-4 hours per day for approximately one week. | Behavioural | Autism Spectrum Disorder, Other Developmental Delay, Typically developing |
| Re-test10 children with ASD will return to repeat the progressive ratio (PR) assessment one week after completing it the first time to examine the reliability of the measure. | Behavioural | Autism Spectrum Disorder |
| Pairing Protocol15 children with ASD will receive an intervention designed to increase social approach after completing the PR assessment. Participants will attend 2 hour appointments 3-5 days per week in which a therapist will deliver highly preferred items, play with the child, work on teaching communication skills, and teach the child to comply with demands. After completing the intervention (once the child is willingly staying near and interacting with the therapist and complying with instructions), the PR assessment will be repeated to measure change due to the intervention. | Behavioural | Autism Spectrum Disorder |
Primary outcome
Breakpoint achieved for each stimulus
Time frame: Up to one week
The highest schedule requirement completed (i.e., breakpoint) is used as a measure of how much an individual is willing to respond for a given stimulus.
Change in breakpoints
Time frame: Assessment 1 through repeat assessment (up to 4 weeks)
For children receiving the intervention the change between breakpoints across the two PR assessments conducted before and after intervention will be examined.
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 12 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Nathan A Call, 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 Training trials, Progressive Ratio Session and Re-test in people with Autism, 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 4 inclusion and 2 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 12 May 2023. 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?
Breakpoint achieved for each stimulus (time frame: Up to one week). The study lists 2 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 12 May 2023.