Problem BehaviorNCT03423940
Resurgence as Choice: Basic and Clinical Studies
A study testing Functional communication training in people with Problem Behavior and Self-injury, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Background: Functional communication training (FCT) is a commonly used intervention for teaching appropriate communication skills to children with intellectual disabilities who exhibit severe destructive behavior. Read more about this study
- Who is it for?
- Ages 3 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior, Self-injury, Communication
- What is being tested?
- Functional communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- males and females between the ages of 3 and 19;
- problem behavior (e.g., aggression, property destruction, self-injurious behavior) that has been the focus of outpatient behavioral and pharmacological treatment but continues to occur, on average, more than once per hour;
- problem behavior reinforced by social consequences (i.e., significantly higher and stable rates of the behavior in one or more social test conditions of a functional analysis [e.g., attention, escape] relative to the control condition [play] and the test condition for automatic reinforcement [alone or ignore]);
- IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate intellectual disability);
- on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes;
- stable educational plan and placement, with no anticipated changes during the study.
Who cannot join
- Exclusion criteria.
- children not meeting the inclusion criteria above;
- children currently receiving intensive (i.e., 15 or more hours per week), function-based, behavioral treatment for their problem behavior through the school or another program;
- DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
- presence of a comorbid health condition (e.g., blindness) or major mental disorder (e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring frequent hospitalizations);
- children with self-injurious behavior who, based on the results of the risk assessment, cannot be exposed to baseline conditions without placing them at risk of serious or permanent harm (e.g., detached retinas);
- children requiring changes in drug treatment (but such children will be invited to participate after they meet the above criteria for a stable drug regimen).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University Center for Autism Research, Education, and Services
Somerset, New Jersey, 08840
About this study
Official title: Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and Developmental Disabilities
Background: Functional communication training (FCT) is a commonly used intervention for teaching appropriate communication skills to children with intellectual disabilities who exhibit severe destructive behavior. Resurgence as Choice (RaC) Theory, a quantitative model of behavior, may help to explain why treatment relapse often occurs after FCT. This project will use the predictions of RaC to improve FCT treatments.
Objective: To test the predictions made by RaC with human participants who exhibit severe destructive behavior.
Eligibility: Children between the ages of 3 and 19 who display destructive behavior that is maintained by social consequences, who have IQ and adaptive behavior scores between 35 and 70, who are on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes, and who have a stable educational plan and placement will be be eligible to enroll.
Read the detailed description
Children with intellectual disabilities often display severe destructive behaviors that pose significant risk to self or others and represent barriers to community integration. These destructive behaviors are often treated with behavioral interventions derived from a functional analysis (FA), which is used to identify the environmental antecedents and consequences that occasion and reinforce (i.e., reward) the target response. One such treatment is called differential reinforcement of alternative behavior (DRA), which involves extinction (i.e., removal of rewards) of destructive behavior and reinforcement of an alternative communication response with the consequence that previously reinforced destructive behavior. Results from review studies indicate that interventions based on an FA, like DRA, typically reduce problem behavior by 90% or more.
One commonly used DRA intervention is functional communication training (FCT). During FCT, clinicians withhold reinforcement for destructive behavior and teach the individual a functional communication response to access reinforcement. For instance, a clinician may teach the child to exchange communication cards to express their wants and needs. However, DRA interventions reported in the literature have typically been evaluated by experts in controlled research settings, and treatment relapse often occurs in the natural environment when a caregiver is unable reinforce the DRA response every time that the response occurs due to competing responsibilities. Accordingly, a recent investigation of 25 applications of DRA found that relapse of problem behavior occurred in 76% of cases.
Resurgence as Choice Theory helps to explain why treatment relapse occurs under these circumstances and also provides mathematical equations that can be used to predict the variables that increase and decrease the likelihood that treatment relapse will occur. In this project, the investigators have used these equations to identify refinements to DRA that are likely to decrease the probability that treatment relapse will occur when the DRA response is not reinforced. In some cases, these refinements are at odds with what is recommended in the clinical literature on DRA. Therefore, it is important to evaluate these refinements that are derived from Resurgence as Choice Theory in order to determine the best way to implement DRA, so that treatment remains effective when it is implemented with less than perfect precision by caregivers in the natural environment.
The two predictions that are most relevant to our project are (a) resurgence of destructive behavior will decrease with increased DRA treatment duration, and (b) resurgence of destructive behavior will decrease with smaller, rather than larger, decreases in the availability of alternative reinforcement during the process of reinforcement schedule thinning. Accordingly, our project will examine the effects of different durations of DRA on resurgence and evaluate the effects of differently sized decreases in the availability of reinforcement to avoid resurgence. Findings from this project could have vast clinical implications for the treatment of severe destructive behavior.
- Conditions
- Problem Behavior, Self-injury, Communication
- Being tested
- Functional communication training
- Medical subject headings
- Problem Behavior, Self-Injurious Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional communication trainingBehavioural
During functional communication training (FCT), the social consequence (e.g., attention, toys, breaks from instructions) that heretofore reinforced destructive behavior (i.e., as determined through a functional analysis) is delivered contingent on an appropriate communication response, while destructive behavior is on extinction (i.e., reinforcers are no longer provided). For example, if a functional analysis shows that aggression is reinforced by escape from demands, FCT would typically involve (a) teaching the child to access breaks from demands via a functional communication response (FCR; e.g., saying, "Break, please") and (b) placing destructive behavior on extinction (i.e., continuing with scheduled demands independent of destructive behavior).
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Treatment Dosage | Experimental | In Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration. Receives: Behavioral: Functional communication training |
| Evaluation of Size of Decrease in Alternative Reinforcement | Experimental | In Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude. Receives: Behavioral: Functional communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate
Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are highest in the test condition predicted by the model to produce the highest rate of responding.
Measured: Through study completion, an average of 4 months.
Secondary outcomes (1)
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate
Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are lowest in the test condition predicted by the model to produce the lowest rate of responding.
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start28 Jun 2018
- Primary completion31 May 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Problem BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Utah State University
- Responsible party
- Principal investigator, Brian D. Greer, Ph.D., BCBA-D, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423940
- Sponsor's protocol ID
- Pro2019001815
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2018
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share our outcome data using the National Database on Autism Research (NDAR). The investigators also plan to share our outcome data on the human participants in these two experiments who are not diagnosed with autism spectrum disorder to better understand how complex, comorbid disorders (e.g., self-injury) differ in individuals with and without autism spectrum disorder.
Publications
Greer BD, Fisher WW, Saini V, Owen TM, Jones JK. Functional communication training during reinforcement schedule thinning: An analysis of 25 applications. J Appl Behav Anal. 2016 Mar;49(1):105-21. doi: 10.1002/jaba.265. Epub 2015 Oct 20.
PubMed 26482103Shahan TA, Craig AR. Resurgence as Choice. Behav Processes. 2017 Aug;141(Pt 1):100-127. doi: 10.1016/j.beproc.2016.10.006. Epub 2016 Oct 26.
PubMed 27794452Craig AR, Shahan TA. Behavioral momentum theory fails to account for the effects of reinforcement rate on resurgence. J Exp Anal Behav. 2016 May;105(3):375-92. doi: 10.1002/jeab.207.
PubMed 27193242Carr EG, Durand VM. Reducing behavior problems through functional communication training. J Appl Behav Anal. 1985 Summer;18(2):111-26. doi: 10.1901/jaba.1985.18-111.
PubMed 2410400Iwata BA, Dorsey MF, Slifer KJ, Bauman KE, Richman GS. Toward a functional analysis of self-injury. J Appl Behav Anal. 1994 Summer;27(2):197-209. doi: 10.1901/jaba.1994.27-197.
PubMed 8063622Tiger JH, Hanley GP, Bruzek J. Functional communication training: a review and practical guide. Behav Anal Pract. 2008 Spring;1(1):16-23. doi: 10.1007/BF03391716.
PubMed 22477675Shadish WR, Hedges LV, Pustejovsky JE. Analysis and meta-analysis of single-case designs with a standardized mean difference statistic: a primer and applications. J Sch Psychol. 2014 Apr;52(2):123-47. doi: 10.1016/j.jsp.2013.11.005. Epub 2013 Dec 27.
PubMed 24606972Hagopian LP, Boelter EW, Jarmolowicz DP. Reinforcement schedule thinning following functional communication training: review and recommendations. Behav Anal Pract. 2011 Summer;4(1):4-16. doi: 10.1007/BF03391770.
PubMed 22532899Saini V, Miller SA, Fisher WW. Multiple schedules in practical application: Research trends and implications for future investigation. J Appl Behav Anal. 2016 Jun;49(2):421-44. doi: 10.1002/jaba.300. Epub 2016 Mar 15.
PubMed 26990754Fisher WW, Kelley ME, Lomas JE. Visual aids and structured criteria for improving visual inspection and interpretation of single-case designs. J Appl Behav Anal. 2003 Fall;36(3):387-406. doi: 10.1901/jaba.2003.36-387.
PubMed 14596583Hyman SL, Fisher W, Mercugliano M, Cataldo MF. Children with self-injurious behavior. Pediatrics. 1990 Mar;85(3 Pt 2):437-41.
PubMed 2304806Emerson E, Kiernan C, Alborz A, Reeves D, Mason H, Swarbrick R, Mason L, Hatton C. The prevalence of challenging behaviors: a total population study. Res Dev Disabil. 2001 Jan-Feb;22(1):77-93. doi: 10.1016/s0891-4222(00)00061-5.
PubMed 11263632
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT03423940
- Acronym / sponsor ID
- Pro2019001815
- Conditions
- Problem Behavior, Self-injury, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Utah State University
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Functional communication training (FCT) is a commonly used intervention for teaching appropriate communication skills to children with intellectual disabilities who exhibit severe destructive behavior. Resurgence as Choice (RaC) Theory, a quantitative model of behavior, may help to explain why treatment relapse often occurs after FCT. This project will use the predictions of RaC to improve FCT treatments.
Objective: To test the predictions made by RaC with human participants who exhibit severe destructive behavior.
Eligibility: Children between the ages of 3 and 19 who display destructive behavior that is maintained by social consequences, who have IQ and adaptive behavior scores between 35 and 70, who are on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes, and who have a stable educational plan and placement will be be eligible to enroll.
Detailed description
Children with intellectual disabilities often display severe destructive behaviors that pose significant risk to self or others and represent barriers to community integration. These destructive behaviors are often treated with behavioral interventions derived from a functional analysis (FA), which is used to identify the environmental antecedents and consequences that occasion and reinforce (i.e., reward) the target response. One such treatment is called differential reinforcement of alternative behavior (DRA), which involves extinction (i.e., removal of rewards) of destructive behavior and reinforcement of an alternative communication response with the consequence that previously reinforced destructive behavior. Results from review studies indicate that interventions based on an FA, like DRA, typically reduce problem behavior by 90% or more.
One commonly used DRA intervention is functional communication training (FCT). During FCT, clinicians withhold reinforcement for destructive behavior and teach the individual a functional communication response to access reinforcement. For instance, a clinician may teach the child to exchange communication cards to express their wants and needs. However, DRA interventions reported in the literature have typically been evaluated by experts in controlled research settings, and treatment relapse often occurs in the natural environment when a caregiver is unable reinforce the DRA response every time that the response occurs due to competing responsibilities. Accordingly, a recent investigation of 25 applications of DRA found that relapse of problem behavior occurred in 76% of cases.
Resurgence as Choice Theory helps to explain why treatment relapse occurs under these circumstances and also provides mathematical equations that can be used to predict the variables that increase and decrease the likelihood that treatment relapse will occur. In this project, the investigators have used these equations to identify refinements to DRA that are likely to decrease the probability that treatment relapse will occur when the DRA response is not reinforced. In some cases, these refinements are at odds with what is recommended in the clinical literature on DRA. Therefore, it is important to evaluate these refinements that are derived from Resurgence as Choice Theory in order to determine the best way to implement DRA, so that treatment remains effective when it is implemented with less than perfect precision by caregivers in the natural environment.
The two predictions that are most relevant to our project are (a) resurgence of destructive behavior will decrease with increased DRA treatment duration, and (b) resurgence of destructive behavior will decrease with smaller, rather than larger, decreases in the availability of alternative reinforcement during the process of reinforcement schedule thinning. Accordingly, our project will examine the effects of different durations of DRA on resurgence and evaluate the effects of differently sized decreases in the availability of reinforcement to avoid resurgence. Findings from this project could have vast clinical implications for the treatment of severe destructive behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Treatment Dosage | Experimental | Behavioral: Functional communication trainingIn Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration. |
| Evaluation of Size of Decrease in Alternative Reinforcement | Experimental | Behavioral: Functional communication trainingIn Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude. |
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- males and females between the ages of 3 and 19;
- problem behavior (e.g., aggression, property destruction, self-injurious behavior) that has been the focus of outpatient behavioral and pharmacological treatment but continues to occur, on average, more than once per hour;
- problem behavior reinforced by social consequences (i.e., significantly higher and stable rates of the behavior in one or more social test conditions of a functional analysis [e.g., attention, escape] relative to the control condition [play] and the test condition for automatic reinforcement [alone or ignore]);
- IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate intellectual disability);
- on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes;
Key exclusion criteria (7 listed)
- Exclusion criteria.
- children not meeting the inclusion criteria above;
- children currently receiving intensive (i.e., 15 or more hours per week), function-based, behavioral treatment for their problem behavior through the school or another program;
- DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
- presence of a comorbid health condition (e.g., blindness) or major mental disorder (e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring frequent hospitalizations);
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 |
|---|---|---|
| Functional communication trainingDuring functional communication training (FCT), the social consequence (e.g., attention, toys, breaks from instructions) that heretofore reinforced destructive behavior (i.e., as determined through a functional analysis) is delivered contingent on an appropriate communication response, while destructive behavior is on extinction (i.e., reinforcers are no longer provided). For example, if a functional analysis shows that aggression is reinforced by escape from demands, FCT would typically involve (a) teaching the child to access breaks from demands via a functional communication response (FCR; e.g., saying, "Break, please") and (b) placing destructive behavior on extinction (i.e., continuing with scheduled demands independent of destructive behavior). | Behavioural | Evaluation of Size of Decrease in Alternative Reinforcement, Evaluation of Treatment Dosage |
Primary outcome
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate
Time frame: Through study completion, an average of 4 months.
Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are highest in the test condition predicted by the model to produce the highest rate of responding.
1 secondary outcome
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate
Time frame: Through study completion, an average of 4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26482103Greer BD, Fisher WW, Saini V, Owen TM, Jones JK. Functional communication training during reinforcement schedule thinning: An analysis of 25 applications. J Appl Behav Anal. 2016 Mar;49(1):105-21. doi: 10.1002/jaba.265. Epub 2015 Oct 20.
- Background: PubMed 27794452Shahan TA, Craig AR. Resurgence as Choice. Behav Processes. 2017 Aug;141(Pt 1):100-127. doi: 10.1016/j.beproc.2016.10.006. Epub 2016 Oct 26.
- Background: PubMed 27193242Craig AR, Shahan TA. Behavioral momentum theory fails to account for the effects of reinforcement rate on resurgence. J Exp Anal Behav. 2016 May;105(3):375-92. doi: 10.1002/jeab.207.
- Background: PubMed 2410400Carr EG, Durand VM. Reducing behavior problems through functional communication training. J Appl Behav Anal. 1985 Summer;18(2):111-26. doi: 10.1901/jaba.1985.18-111.
- Background: PubMed 8063622Iwata BA, Dorsey MF, Slifer KJ, Bauman KE, Richman GS. Toward a functional analysis of self-injury. J Appl Behav Anal. 1994 Summer;27(2):197-209. doi: 10.1901/jaba.1994.27-197.
- Background: PubMed 22477675Tiger JH, Hanley GP, Bruzek J. Functional communication training: a review and practical guide. Behav Anal Pract. 2008 Spring;1(1):16-23. doi: 10.1007/BF03391716.
- Background: PubMed 24606972Shadish WR, Hedges LV, Pustejovsky JE. Analysis and meta-analysis of single-case designs with a standardized mean difference statistic: a primer and applications. J Sch Psychol. 2014 Apr;52(2):123-47. doi: 10.1016/j.jsp.2013.11.005. Epub 2013 Dec 27.
- Background: PubMed 22532899Hagopian LP, Boelter EW, Jarmolowicz DP. Reinforcement schedule thinning following functional communication training: review and recommendations. Behav Anal Pract. 2011 Summer;4(1):4-16. doi: 10.1007/BF03391770.
- Background: PubMed 26990754Saini V, Miller SA, Fisher WW. Multiple schedules in practical application: Research trends and implications for future investigation. J Appl Behav Anal. 2016 Jun;49(2):421-44. doi: 10.1002/jaba.300. Epub 2016 Mar 15.
- Background: PubMed 14596583Fisher WW, Kelley ME, Lomas JE. Visual aids and structured criteria for improving visual inspection and interpretation of single-case designs. J Appl Behav Anal. 2003 Fall;36(3):387-406. doi: 10.1901/jaba.2003.36-387.
- Background: PubMed 2304806Hyman SL, Fisher W, Mercugliano M, Cataldo MF. Children with self-injurious behavior. Pediatrics. 1990 Mar;85(3 Pt 2):437-41.
- Background: PubMed 11263632Emerson E, Kiernan C, Alborz A, Reeves D, Mason H, Swarbrick R, Mason L, Hatton C. The prevalence of challenging behaviors: a total population study. Res Dev Disabil. 2001 Jan-Feb;22(1):77-93. doi: 10.1016/s0891-4222(00)00061-5.
- Individual participant dataSharing planned: Yes. The investigators plan to share our outcome data using the National Database on Autism Research (NDAR). The investigators also plan to share our outcome data on the human participants in these two experiments who are not diagnosed with autism spectrum disorder to better understand how complex, comorbid disorders (e.g., self-injury) differ in individuals with and without autism spectrum disorder.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional communication training in people with Problem Behavior and Self-injury, run by Rutgers, The State University of New Jersey 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 6 inclusion and 7 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 3 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate (time frame: Through study completion, an average of 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423940, which also lists 12 linked publications.
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 3 Sep 2024.