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This project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (IDD) and the prevalence of extinction bursts. Extinction bursts, or temporary increases in rates and intensities of behavior during extinction, often preclude the inclusion of extinction in intervention packages meant to suppress severe challenging behavior, despite the fact that extinction is often necessary to generate therapeutic outcomes. Study results will provide insight into how researchers can enhance interventions for the severe challenging behavior of individuals with IDD while mitigating the undesirable collateral effects (i.e., extinction bursts) of therapeutic action (i.e., extinction). Expanded access to study results will be made available to those who inquire after all data have been obtained and analyzed.
The Goal of this project is to identify mechanisms responsible for bursts, and to facilitate strategic extensions toward discovery for treatments of challenging behavior. AIM 1: In the service of this goal, the investigators aim to evaluate the accuracy of an efficient alternative to demand-curve analysis (i.e., progressive ratio reinforcer analysis) in quantifying reinforcer value (i.e., Pmax). AIM 2: Investigators also aim to evaluate the utility of manipulating baseline reinforcement parameters for controlling bursts when those manipulations are informed by the results of demand-curve analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Cheap" Unit Price, Establishing Operation | Experimental | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. |
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| "Cheap" Unit Price, Abolishing Operation | Experimental | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. |
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| "Expensive" Unit Price, Establishing Operation | Experimental | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. |
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| "Expensive" Unit Price, Abolishing Operation | Experimental | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demand Informed Moderator Analysis | Behavioral | This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Response Rate During Extinction | This term describes the highest rate of responding observed during extinction and will be depicted as a proportion of baseline. For example, assuming the mean rate of responding during the final three sessions of baseline is 3 responses per minute (i.e., [2.8 rpm + 3.2 rpm + 3 rpm] / 3 = 3 rpm), and the highest rate of responding during a single session of extinction is 3.4 rpm, then peak response rate for this hypothetical individual would be 1.13 (i.e., 3.4 / 3 = 1.13). This value will serve as the primary dependent variable for each participant in all between-groups comparisons in our data-analysis plan. | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
| Schedule Value at Breakpoint | The progressive-ratio reinforcer analysis (PRA) is a game of diminishing returns that is considered an assessment of reinforcer value (e.g., if a participant does not value the reinforcer, they will quit sooner than a participant that does value the reinforcer). During the assessment, we increased the "price" (i.e., the schedule value) of reinforcers each time a participant earns two reinforcers at a currently established price. The breakpoint describes the "price" (schedule value; e.g., FR1, FR4, FR7) of the last obtained reinforcer prior to response cessation (i.e., the breakpoint is the last schedule value that supported enough responding to produce a reinforcer, before the participant quit playing the game). Higher breakpoints are interpreted as reflecting higher-value reinforcers. Lower breakpoints are interpreted as reflecting lower-value reinforcers. | PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment. |
| The Schedule Value Designated as Pmax | The progressive fixed-ratio reinforcer analysis (PFRA) is an assessment of consumer demand that first establishes how much of a reinforcer a participant would consume when consumption is free of constraint (i.e., when participants can have as much of the reinforcer as they want; referred to as "bliss-point consumption"). With bliss-point consumption established, PFRA evaluates how much a participant will "spend" (respond) to maintain bliss-point consumption patterns as price (schedule value) is increased. Unlike PRA, prices in the PFRA are held constant within each session and only increase across sessions. Initially, participants "spend" more. Eventually, they "spend" less. The price that produces maximum "spending" (i.e., higher and lower prices yield lower response outputs) is referred to as Pmax. Pmax is one way to quantify a reinforcer's value. That is, reinforcers that produce high Pmax have more value than reinforcers that produce low Pmax. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sessions in Extinction | In addition to between-groups differences in peak-response rate (primary dependent variable), the investigators will also compare between-groups differences in the number of sessions required to achieve response elimination during extinction. | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Habilitative and Training Services (HATS) | Gallatin | Tennessee | 37066 | United States | ||
| Easterseals Tennessee: Prospect |
Peer-reviewed published empirical reports will follow CONSORT reporting guidelines, as well as other principles of rigor and transparency highlighted through the Equator network (https://www.equator-network.org/).
Study protocol, SAP, & ICF will be submitted within 12 months of study completion and will be made available indefinitely. Complete reports will be submitted for peer review within 12 months of study completion.
Data and materials will be made available upon request.
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Prior to randomization, all participants completed an assessment (i.e., the progressive-ratio analysis) that generated our matching variable (i.e., the "breakpoint" produced by the targeted reinforcer).
Five participants dropped out during this assessment (prior to randomization). The reasons for dropping out were scheduling conflicts (x4) and a significant health concern unrelated to this study (x1).
Recruitment entailed flyer distribution through relevant program directors. Directors vetted interest and only passed along contact information of individuals from their organization who expressed interest in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | "Cheap" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| FG001 | "Cheap" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| FG002 | "Expensive" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| FG003 | "Expensive" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | "Cheap" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Response Rate During Extinction | This term describes the highest rate of responding observed during extinction and will be depicted as a proportion of baseline. For example, assuming the mean rate of responding during the final three sessions of baseline is 3 responses per minute (i.e., [2.8 rpm + 3.2 rpm + 3 rpm] / 3 = 3 rpm), and the highest rate of responding during a single session of extinction is 3.4 rpm, then peak response rate for this hypothetical individual would be 1.13 (i.e., 3.4 / 3 = 1.13). This value will serve as the primary dependent variable for each participant in all between-groups comparisons in our data-analysis plan. | Posted | Mean | Standard Deviation | Proportion of baseline (frequency) | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
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Participants spent an average of 73.7 (range 5-323) calendar days completing this study. Adverse events were monitored during appointments throughout study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Cheap" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Lambert | Vanderbilt University | 615-343-0824 | joseph.m.lambert@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2021 | Oct 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2022 | Oct 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D002658 | Developmental Disabilities |
| D008607 | Intellectual Disability |
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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The investigators will enroll 80 adults with developmental disabilities in a low-stakes translational investigation employing a 2x2 factorial, crossed, and randomized matched blocks design, with batched randomization logic. Procedures will include: (a) matching participants within batches according to progressive ratio reinforcer analysis results, and (b) randomly assigning participants to one of four experimental conditions to determine whether information about reinforcer value can be used to set baseline parameters that either promote or eliminate bursts during extinction.
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Participants will be randomized to one of four baseline reinforcement conditions. They will not be informed of which condition they have been assigned to, or why they have been assigned to it.
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| Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters. |
| Response Latency | This term describes the latency from session onset to eventual response cessation during the extinction challenge. | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
| Overall Session Duration | The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters. | Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters. |
| Lebanon |
| Tennessee |
| 37060 |
| United States |
| Possibility Place | Murfreesboro | Tennessee | 37133 | United States |
| Next Steps at Vanderbilt | Nashville | Tennessee | 37203 | United States |
| Chrysalis | Orem | Utah | 84057 | United States |
| Protocol Violation |
|
| BG001 | "Cheap" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| BG002 | "Expensive" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| BG003 | "Expensive" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Disability | It was possible for participants to be diagnosed with more than one disability | Count of Participants | Participants |
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| OG001 | "Cheap" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| OG002 | "Expensive" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
| OG003 | "Expensive" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). |
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| Primary | Schedule Value at Breakpoint | The progressive-ratio reinforcer analysis (PRA) is a game of diminishing returns that is considered an assessment of reinforcer value (e.g., if a participant does not value the reinforcer, they will quit sooner than a participant that does value the reinforcer). During the assessment, we increased the "price" (i.e., the schedule value) of reinforcers each time a participant earns two reinforcers at a currently established price. The breakpoint describes the "price" (schedule value; e.g., FR1, FR4, FR7) of the last obtained reinforcer prior to response cessation (i.e., the breakpoint is the last schedule value that supported enough responding to produce a reinforcer, before the participant quit playing the game). Higher breakpoints are interpreted as reflecting higher-value reinforcers. Lower breakpoints are interpreted as reflecting lower-value reinforcers. | Posted | Mean | Standard Deviation | Schedule Value at Breakpoint | PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment. |
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| Primary | The Schedule Value Designated as Pmax | The progressive fixed-ratio reinforcer analysis (PFRA) is an assessment of consumer demand that first establishes how much of a reinforcer a participant would consume when consumption is free of constraint (i.e., when participants can have as much of the reinforcer as they want; referred to as "bliss-point consumption"). With bliss-point consumption established, PFRA evaluates how much a participant will "spend" (respond) to maintain bliss-point consumption patterns as price (schedule value) is increased. Unlike PRA, prices in the PFRA are held constant within each session and only increase across sessions. Initially, participants "spend" more. Eventually, they "spend" less. The price that produces maximum "spending" (i.e., higher and lower prices yield lower response outputs) is referred to as Pmax. Pmax is one way to quantify a reinforcer's value. That is, reinforcers that produce high Pmax have more value than reinforcers that produce low Pmax. | Posted | Mean | Standard Deviation | The Schedule Value Designated as Pmax | Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters. |
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| Primary | Response Latency | This term describes the latency from session onset to eventual response cessation during the extinction challenge. | Posted | Mean | Standard Deviation | seconds | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
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| Secondary | Number of Sessions in Extinction | In addition to between-groups differences in peak-response rate (primary dependent variable), the investigators will also compare between-groups differences in the number of sessions required to achieve response elimination during extinction. | Posted | Mean | Standard Deviation | Number of sessions in extinction | This measure was obtained throughout the primary assessment (i.e., the extinction challenge) |
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| Secondary | Overall Session Duration | The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters. | Posted | Mean | Standard Deviation | seconds | Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters. |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | "Cheap" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | "Expensive" Unit Price, Establishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | "Expensive" Unit Price, Abolishing Operation | Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand. Demand Informed Moderator Analysis: This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control). | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D002652 | Child Behavior |