Resurgence as Choice: Basic and Clinical Studies

NCT03423940 | Completed Results

• 1 other identifier: Pro2019001815
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Problem Behavior; Self-injury; Communication

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Through study completion, an average of 4 months.

Study Arms (2)

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.

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.

Behavioral: Functional communication training

Interventions

Functional communication training BEHAVIORAL

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).

Evaluation of Size of Decrease in Alternative Reinforcement; Evaluation of Treatment Dosage

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Utah State University: collaborator

Study Sites (1)

Rutgers University Center for Autism Research, Education, and Services

Somerset, New Jersey, 08840, United States

Location

Related Publications (12)

• 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.

  PMID: 26482103 BACKGROUND

• 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.

  PMID: 27794452 BACKGROUND

• Craig 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.

  PMID: 27193242 BACKGROUND

• Carr 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.

  PMID: 2410400 BACKGROUND

• Iwata 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.

  PMID: 8063622 BACKGROUND

• Tiger 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.

  PMID: 22477675 BACKGROUND

• Shadish 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.

  PMID: 24606972 BACKGROUND

• 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.

  PMID: 22532899 BACKGROUND

• Saini 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.

  PMID: 26990754 BACKGROUND

• Fisher 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.

  PMID: 14596583 BACKGROUND

• Hyman SL, Fisher W, Mercugliano M, Cataldo MF. Children with self-injurious behavior. Pediatrics. 1990 Mar;85(3 Pt 2):437-41.

  PMID: 2304806 BACKGROUND

• Emerson 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.

  PMID: 11263632 BACKGROUND

MeSH Terms

Conditions

Problem Behavior; Self-Injurious Behavior; Communication

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Results Point of Contact

• Title: Brian D. Greer, Ph.D., BCBA-D
• Organization: Rutgers, The State University of New Jersey

brian.greer@rutgers.edu

848-800-8505

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consortium Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 6, 2018
• Study Start: June 28, 2018
• Primary Completion: May 31, 2023
• Study Completion: August 2, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)