Clinical trial NCT05790668: Motivational Refinements for Facilitating Reinforcement Schedule Thinning
Official title: Motivational Refinements for Facilitating Reinforcement Schedule Thinning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decreasing Destructive Behavior
Increasing Functional Communicative Behavior
Keywords: functional communication training
reinforcement schedule thinning
resurgence
treatment relapse
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Destructive behavior represents a comorbid condition of developmental disability for which risk increases with intellectual disability severity, communication deficits, and co-occurring autism spectrum disorder. Destructive behavior, such as self-injurious behavior and aggression, causes harm to the child and others and increases the risk for institutionalization, social isolation, physical restraint, medication overuse, and abuse. Clinicians have used functional analyses to identify the variables that reinforce destructive behavior and to develop effective, function-based treatments. Functional communication training (FCT) is an empirically supported, function-based treatment that decreases destructive behavior. Using FCT, the clinician teaches the child to use a functional communication response (FCR) to request the reinforcer maintaining destructive behavior, while placing destructive behavior on extinction. For example, if functional analysis results showed that attention reinforced destructive behavior, the clinician would provide attention when the child used the FCR ("Play with me, please") and would not provide attention for destructive behavior. Two limitations of FCT are that (a) schedules of reinforcement maintaining the FCR must often be thinned gradually to levels that are practical for caregivers to implement consistently in the home and in the community, and (b) this necessary process of reinforcement schedule thinning regularly causes destructive behavior to increase following initially effective treatment, a form of treatment relapse called resurgence. The current project aims to improve these limitations of FCT by (a) hastening the process of reinforcement schedule thinning by removing unnecessary schedule-thinning steps using the results of a progressive interval assessment and (b) mitigating the resurgence of destructive behavior by providing stimuli that highly compete with the reinforcer maintaining destructive behavior. The investigators will conduct a randomized clinical trial to evaluate the extent to which these two promising refinements to FCT improve the process of reinforcement schedule thinning, and an exploratory experiment will examine the interactive effects of these two approaches. This novel project has the potential to substantially improve standards of care guiding the treatment of severe destructive behavior and to improve the long-term outcomes for children and families afflicted by these debilitating behavior disorders.

Detailed description: The severe destructive behavior (e.g., self-injury, aggression) of children with intellectual developmental disorder is prevalent, often dangerous, and negatively impacts social integration and quality of life (Borthwick-Duffy, 1994; Crocker et al., 2006). Function-based interventions that rely on differential reinforcement of alternative behavior reduce such problematic behavior effectively (Greer et al., 2016; Hagopian et al., 1998; Rooker et al., 2013), but the clinical utility of this approach is hampered in two critically important ways. First, schedules of reinforcement maintaining alternative behavior must be thinned to levels that are practical for caregivers to implement consistently in the home and in the community (Greer et al., 2016; Hagopian et al., 2011). This necessary process of schedule thinning often requires substantial time and resources to complete and typically comprises the most expensive portion of routine, clinical service delivery for this referral concern. Second, and exacerbating the first, is the consistent finding that schedule thinning often produces a form of treatment relapse called resurgence (Briggs et al., 2018; Mitteer et al., 2022; Muething et al., 2020; Shahan et al., 2020). The experimenters propose two clinically indicated, and theoretically grounded, methods of accelerating the process of schedule thinning while mitigating the resurgence of severe destructive behavior.

Recent research from the investigators has shown that the quantitative theory of resurgence called Resurgence as Choice (RaC) (Greer \& Shahan, 2019; Shahan et al., 2019; Shahan \& Craig, 2017) accurately describes how decrements in the availability of reinforcement predict the amount of resurgence of destructive behavior during the process of schedule thinning (Shahan \& Craig, 2017), a finding recently verified in a nonhuman animal study (Shahan et al., 2020). Importantly, clinical and laboratory research alike has shown, as RaC predicts, that simply thinning reinforcement in small, gradual steps, the approach most commonly used by clinicians, does not prevent resurgence-relapse inevitably occurs once the schedule reaches a break point (Briggs et al., 2018; Shahan et al., 2020; Shahan \& Craig, 2017; Shahan \& Greer, 2021). RaC theory states that motivation for the functional reinforcer maintaining destructive behavior (parameter a in RaC equations) plays an important role in determining whether and to what extent destructive behavior will resurge during schedule thinning (Greer et al., 2019; Shahan et al., 2019; Shahan \& Craig, 2017), a prediction well-supported by recent pilot work from the investigators on (a) individualizing the starting point for schedule thinning using a progressive interval assessment (PIA) (Miller et al., 2021) and (b) providing competing stimuli to hasten schedule thinning (Fuhrman et al, 2018; Miller et al., 2021). According to RaC theory, these two clinically indicated manipulations facilitate schedule thinning by respectively (a) tailoring the initial schedule of reinforcement to each patient's unique level of motivation for the functional reinforcer and (b) dampening motivation for the functional reinforcer by delivering an alternative and competing source of reinforcement. Additionally, theoretical and empirical work in the area of behavioral economics provides independent support for these two manipulations. This project will further the clinical and theoretical understanding of how motivational variables affect resurgence as it occurs in practice, and the project has the potential to substantially improve standards of care guiding the treatment of severe destructive behavior.

The experimenters will conduct a study to identify whether quantitatively informed refinements can improve efficiency and efficacy of reinforcement schedule thinning when treating severe destructive behavior. The project has three specific aims:

Specific Aim 1: The experimenters will extend pilot work on the utility of individualizing the starting point for reinforcement schedule thinning based on the results of a PIA. The experimenters will accomplish this by conducting reinforcement schedule thinning in two distinct stimulus contexts, one informed by the results of a PIA and another not so informed.

Specific Aim 2: Basing the starting point on a PIA, the experimenters will assess the extent to which providing competing stimuli from a competing stimulus assessment quickens the process of schedule thinning when competing stimuli are available in one, but not another, unique stimulus context.

Specific Aim 3: The experimenters will examine the potential interaction effects between these two approaches by conducting PIAs with no, low, moderate, and high competing stimuli to determine the schedule duration at which schedule thinning should commence with each competing stimulus.

Eligibility criteria: Inclusion Criteria:

* boys and girls from ages 3 to 17
* destructive behavior that occurs at least 10 times a day, despite previous treatment
* destructive behavior reinforced by social consequences
* stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment
* on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free
* stable educational plan and placement with no anticipated changes during the child's treatment

Exclusion Criteria:

* patients who do not meet the inclusion criteria
* patients currently receiving 15 or more hours per week of treatment for their destructive behavior
* Diagnostic and Statistical Manual-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism)
* a comorbid health condition or major mental disorder that would interfere with study participation
* occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on routine clinical-risk assessment
* patients requiring changes to protective supports for self-injury or drug treatment, but investigators will invite these patients to participate when protective supports and drug regimen are stable

Primary outcomes:
measure: Destructive behavior (responses per minute)
timeFrame: Through study completion, an average of 4 weeks.
measure: Discriminated functional communication responses (percentage)
timeFrame: Through study completion, an average of 4 weeks.
measure: Efficiency of schedule thinning
timeFrame: Through study completion, an average of 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Douglass Developmental Disabilities Center
state: New Jersey
city: Somerset
country: United States
facility: Rutgers University Center for Autism Research, Education, and Services
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Brian D Greer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borthwick-Duffy SA. Epidemiology and prevalence of psychopathology in people with mental retardation. J Consult Clin Psychol. 1994 Feb;62(1):17-27. doi: 10.1037//0022-006x.62.1.17.
citation: Briggs AM, Fisher WW, Greer BD, Kimball RT. Prevalence of resurgence of destructive behavior when thinning reinforcement schedules during functional communication training. J Appl Behav Anal. 2018 Jul;51(3):620-633. doi: 10.1002/jaba.472. Epub 2018 May 17.
citation: Crocker AG, Mercier C, Lachapelle Y, Brunet A, Morin D, Roy ME. Prevalence and types of aggressive behaviour among adults with intellectual disabilities. J Intellect Disabil Res. 2006 Sep;50(Pt 9):652-61. doi: 10.1111/j.1365-2788.2006.00815.x.
citation: Fuhrman AM, Greer BD, Zangrillo AN, Fisher WW. Evaluating competing activities to enhance functional communication training during reinforcement schedule thinning. J Appl Behav Anal. 2018 Oct;51(4):931-942. doi: 10.1002/jaba.486. Epub 2018 Jun 29.
citation: 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.
citation: Greer BD, Shahan TA. Resurgence as Choice: Implications for promoting durable behavior change. J Appl Behav Anal. 2019 Jul;52(3):816-846. doi: 10.1002/jaba.573. Epub 2019 May 3.
citation: Hagopian 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.
citation: Hagopian LP, Fisher WW, Sullivan MT, Acquisto J, LeBlanc LA. Effectiveness of functional communication training with and without extinction and punishment: a summary of 21 inpatient cases. J Appl Behav Anal. 1998 Summer;31(2):211-35. doi: 10.1901/jaba.1998.31-211.
citation: Miller SA, Fisher WW, Greer BD, Saini V, Keevy MD. Procedures for determining and then modifying the extinction component of multiple schedules for destructive behavior. J Appl Behav Anal. 2022 Mar;55(2):463-480. doi: 10.1002/jaba.896. Epub 2021 Dec 12.
citation: Mitteer DR, Greer BD, Randall KR, Haney SD. On the scope and characteristics of relapse when treating severe destructive behavior. J Appl Behav Anal. 2022 Jun;55(3):688-703. doi: 10.1002/jaba.912. Epub 2022 Mar 15.
citation: Muething C, Pavlov A, Call N, Ringdahl J, Gillespie S. Prevalence of resurgence during thinning of multiple schedules of reinforcement following functional communication training. J Appl Behav Anal. 2021 Apr;54(2):813-823. doi: 10.1002/jaba.791. Epub 2020 Oct 25.
citation: Rooker GW, Jessel J, Kurtz PF, Hagopian LP. Functional communication training with and without alternative reinforcement and punishment: an analysis of 58 applications. J Appl Behav Anal. 2013 Dec;46(4):708-22. doi: 10.1002/jaba.76. Epub 2013 Aug 22.
citation: Shahan TA, Browning KO, Nall RW. Resurgence as Choice in Context: Treatment duration and on/off alternative reinforcement. J Exp Anal Behav. 2020 Jan;113(1):57-76. doi: 10.1002/jeab.563. Epub 2019 Nov 27.
citation: Shahan TA, Browning KO, Nist AN, Sutton GM. Resurgence and downshifts in alternative reinforcement rate. J Exp Anal Behav. 2020 Sep;114(2):163-178. doi: 10.1002/jeab.625. Epub 2020 Aug 27.
citation: Shahan 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.
citation: Shahan TA, Greer BD. Destructive behavior increases as a function of reductions in alternative reinforcement during schedule thinning: A retrospective quantitative analysis. J Exp Anal Behav. 2021 Sep;116(2):243-248. doi: 10.1002/jeab.708. Epub 2021 Jul 4.