Intellectual Disabilities (F70-F79)NCT07137273
Optimizing Dimensions of Reinforcement
A study testing Operant Conditioning Tasks with Reinforcement Manipulations in people with Intellectual Disabilities (F70-F79) and Autism, run by Auburn University at 3 sites in United States.
Trial summary
This study is designed to better understand how certain features of reinforcement affect learning and motivation in individuals with intellectual and developmental disabilities (IDD). Participants will take part in a series of structured teaching sessions that involve simple tasks and reward-based feedback. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Intellectual Disabilities (F70-F79), Autism
- What is being tested?
- Operant Conditioning Tasks with Reinforcement Manipulations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 6 years of age
- Documented neurodevelopmental condition
- Engagement in problem behavior (e.g., aggression, self-injury, property destruction) that can be measured during study sessions
- Ability to follow simple instructions
- Ability to participate in tabletop choice-based tasks
- Availability to complete all scheduled study sessions
- Provision of informed consent by participant or legally authorized representative
Who cannot join
- Severe sensory or motor impairments that would prevent participation in tabletop tasks
- Current or recent participation (within the past 30 days) in another interventional behavioral research study that could interfere with study outcomes
- Medical or behavioral conditions judged by investigators to pose a safety risk or interfere with data collection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Center for Autism Research, Treatment, and Training
Auburn, Alabama, 36830
John Falligant, 205-807-2371, jmf0031@auburn.edu
Madeline Levin, M.S., 334-844-4412, mjl0083@auburn.edu
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Louis P Hagopian, PhD, 443-923-2841, hagopian@kennedykrieger.org
- Recruiting
Oakland University
Rochester Hills, Michigan, 48309
Michael P Kranak, PhD, 304-374-5150, kranak@oakland.edu
About this study
Official title: Optimizing Dimensions of Reinforcement to Enhance Behavioral Interventions
This study is designed to better understand how certain features of reinforcement affect learning and motivation in individuals with intellectual and developmental disabilities (IDD). Participants will take part in a series of structured teaching sessions that involve simple tasks and reward-based feedback. By changing the timing and amount of rewards, we aim to learn how these factors influence the ability to acquire and maintain new skills. This information may help improve behavioral interventions for individuals with IDD in the future. The study does not involve medications or procedures intended to change participants' health status.
Read the detailed description
This study examines how key parameters of reinforcement-specifically the timing and amount of rewards-affect learning, motivation, and performance in individuals with intellectual and developmental disabilities (IDD). The experimental design is informed by the Mathematical Principles of Reinforcement (MPR), a quantitative framework for understanding the relationship between reinforcement schedules and behavior.
Participants will complete tabletop tasks in a controlled setting. Tasks are designed to be simple and accessible, such as pressing a button or selecting a picture, and correct responses will earn small rewards. Across sessions, we will systematically vary reinforcement parameters, including inter-reinforcement interval and reinforcer magnitude, to evaluate their effects on response rate, accuracy, and persistence.
This is a Basic Experimental Studies with Humans (BESH) clinical trial, meaning the interventions are intended to understand fundamental behavioral processes, not to produce direct clinical benefit. The data will be analyzed using statistical models derived from MPR to identify which reinforcement dimensions are most effective in maintaining high rates of responding. The results may help refine behavior intervention strategies for individuals with IDD by providing an evidence-based understanding of how to optimize reinforcement delivery.
- Conditions
- Intellectual Disabilities (F70-F79), Autism
- Being tested
- Operant Conditioning Tasks with Reinforcement Manipulations
- Keywords
- Operant Conditioning, Neurodevelopmental disorders, Behavioral interventions
- Medical subject headings
- Intellectual Disability, Autistic Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant Conditioning Tasks with Reinforcement ManipulationsBehavioural
This behavioral intervention involves structured operant conditioning tasks. Reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically manipulated to evaluate their effects on behavioral allocation. The primary objective is to assess how variations in reinforcement contingencies influence choice patterns. The procedures are designed to examine fundamental behavioral processes rather than to provide therapeutic benefit.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm: Manipulation of Reinforcement Schedules | Experimental | Participants will complete an operant conditioning task in which reinforcement schedules are systematically manipulated to evaluate changes in response patterns. All participants receive the same sequence of experimental conditions, which involve varying the availability and distribution of points exchangeable for preferred items or activities. No health-related treatment is provided; the procedures are designed to examine basic behavioral processes related to reinforcement dynamics. Receives: Behavioral: Operant Conditioning Tasks with Reinforcement Manipulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of behavior across schedules
Number of target responses allocated emitted during experimental sessions in which reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically varied. This measure will be derived from response data recorded during operant conditioning tasks. Changes in allocation patterns will be compared across schedule conditions to assess the effect of reinforcement manipulations.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start7 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disabilities (F70-F79)Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same sequence of experimental conditions. The design allows for within-subject comparisons across phases of the intervention to evaluate changes in operant responding under different schedule arrangements.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Oakland University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Responsible party
- Principal investigator, John Michael Falligant, Auburn University
- Investigators
- John M Falligant, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137273
- Sponsor's protocol ID
- R21HD113881
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and confidentiality, only aggregate data and summary results will be disseminated through publications, presentations, and ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dimensions of Reinforcement to Enhance Behavioral Interventions
- ClinicalTrials.gov ID
- NCT07137273
- Acronym / sponsor ID
- R21HD113881
- Conditions
- Intellectual Disabilities (F70-F79), Autism
- Keywords
- Operant Conditioning, Neurodevelopmental disorders, Behavioral interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Oakland University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Aug 2025 (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.
This study is designed to better understand how certain features of reinforcement affect learning and motivation in individuals with intellectual and developmental disabilities (IDD). Participants will take part in a series of structured teaching sessions that involve simple tasks and reward-based feedback. By changing the timing and amount of rewards, we aim to learn how these factors influence the ability to acquire and maintain new skills. This information may help improve behavioral interventions for individuals with IDD in the future. The study does not involve medications or procedures intended to change participants' health status.
Detailed description
This study examines how key parameters of reinforcement-specifically the timing and amount of rewards-affect learning, motivation, and performance in individuals with intellectual and developmental disabilities (IDD). The experimental design is informed by the Mathematical Principles of Reinforcement (MPR), a quantitative framework for understanding the relationship between reinforcement schedules and behavior.
Participants will complete tabletop tasks in a controlled setting. Tasks are designed to be simple and accessible, such as pressing a button or selecting a picture, and correct responses will earn small rewards. Across sessions, we will systematically vary reinforcement parameters, including inter-reinforcement interval and reinforcer magnitude, to evaluate their effects on response rate, accuracy, and persistence.
This is a Basic Experimental Studies with Humans (BESH) clinical trial, meaning the interventions are intended to understand fundamental behavioral processes, not to produce direct clinical benefit. The data will be analyzed using statistical models derived from MPR to identify which reinforcement dimensions are most effective in maintaining high rates of responding. The results may help refine behavior intervention strategies for individuals with IDD by providing an evidence-based understanding of how to optimize reinforcement delivery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same sequence of experimental conditions. The design allows for within-subject comparisons across phases of the intervention to evaluate changes in operant responding under different schedule arrangements.
| Arm | Type | Receives |
|---|---|---|
| Single-Arm: Manipulation of Reinforcement Schedules | Experimental | Behavioral: Operant Conditioning Tasks with Reinforcement ManipulationsParticipants will complete an operant conditioning task in which reinforcement schedules are systematically manipulated to evaluate changes in response patterns. All participants receive the same sequence of experimental conditions, which involve varying the availability and distribution of points exchangeable for preferred items or activities. No health-related treatment is provided; the procedures are designed to examine basic behavioral processes related to reinforcement dynamics. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- At least 6 years of age
- Documented neurodevelopmental condition
- Engagement in problem behavior (e.g., aggression, self-injury, property destruction) that can be measured during study sessions
- Ability to follow simple instructions
- Ability to participate in tabletop choice-based tasks
Key exclusion criteria (3 listed)
- Severe sensory or motor impairments that would prevent participation in tabletop tasks
- Current or recent participation (within the past 30 days) in another interventional behavioral research study that could interfere with study outcomes
- Medical or behavioral conditions judged by investigators to pose a safety risk or interfere with data collection
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 |
|---|---|---|
| Operant Conditioning Tasks with Reinforcement ManipulationsThis behavioral intervention involves structured operant conditioning tasks. Reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically manipulated to evaluate their effects on behavioral allocation. The primary objective is to assess how variations in reinforcement contingencies influence choice patterns. The procedures are designed to examine fundamental behavioral processes rather than to provide therapeutic benefit. | Behavioural | Single-Arm: Manipulation of Reinforcement Schedules |
Primary outcome
Change in rate of behavior across schedules
Time frame: 3 months
Number of target responses allocated emitted during experimental sessions in which reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically varied. This measure will be derived from response data recorded during operant conditioning tasks. Changes in allocation patterns will be compared across schedule conditions to assess the effect of reinforcement manipulations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No. To protect participant privacy and confidentiality, only aggregate data and summary results will be disseminated through publications, presentations, and ClinicalTrials.gov.
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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.
Center for Autism Research, Treatment, and Training
Auburn, United States
John M Falligant, PhD principal investigator
Auburn University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operant Conditioning Tasks with Reinforcement Manipulations in people with Intellectual Disabilities (F70-F79) and Autism, run by Auburn University at 3 sites 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of behavior across schedules (time frame: 3 months). 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 27 Aug 2025.