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临床试验/NCT05928247
NCT05928247招募中不适用

Manualized Assessment and Treatment Model of Challenging Behavior

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Rate of Problem Behavior

研究概览

简要总结

Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.

详细描述

The investigators will stratify participants according to the severity of their challenging behavior (harmful or milder forms of challenging behavior).

Criteria for Harmful Challenging Behavior Participants will be classified as exhibiting harmful challenging behavior if they meet all the following criteria and as exhibiting milder challenging behavior if they do not meet all these criteria.

  1. The child displays one or more of the following challenging behaviors (operationally defined on the Destructive Behavior Severity Scale, see attached) daily: (a) aggression, (b) elopement, (c) injury risk behavior, (d) pica, (e) property destruction, and/or (f) SIB.
  2. The child's challenging behaviors are at a severity level that poses a clear and serious risk to oneself, others, or the environment (Severity Level 2 or higher on the Destructive Behavior Severity Scale, see attached).
  3. The child's challenging behavior causes clear and significant stress on the child's family members (e.g., siblings are deprived of parental attention; family members are restricted from maintaining employment, going on family outings, attending church, eating at a restaurant, or taking a vacation due to the child's challenging behavior).
  4. The child has had at least 3 months of outpatient behavior therapy with insufficient improvement in the challenging behavior or the child's challenging behavior poses an imminent danger to oneself or others such that less intensive services would be contraindicated.
  5. The child has had at least 3 months of outpatient psychopharmacological intervention by a psychiatrist or developmental pediatrician with insufficient improvement in the challenging behavior, or the psychiatrist or developmental pediatrician has recommended adding intensive behavioral intervention.

The manualized protocol has three general components that will be used with participants in both groups including: (a) assessment, (b) treatment, and (c) caregiver training and generalization.

Assessment

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children from ages 3 to 17;
  • challenging behavior that occurs at least 10 times a day, despite previous treatment;
  • challenging behavior maintained by social positive or automatic reinforcement;
  • 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.

排除标准

  • patients who do not meet the inclusion criteria;
  • patients currently receiving 15 or more hours per week of treatment for their challenging behavior;
  • DSM-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 our routine clinical-risk assessment (Betz, 2011);
  • patients requiring changes to protective supports for self-injury or drug treatment, but the investigators will invite these patients to participate when protective supports and drug regimen are stable.

研究组 & 干预措施

Functional Analysis Treatment for Harmful Challenging Behavior

Experimental

If challenging behavior is found to be socially maintained, the investigators will recommend functional communication training (FCT) to teach a functional communication response (FCR) (e.g., touching a card with a picture of the participant consuming the reinforcer), but the investigators will also offer NCR as a potential treatment option to the caregivers. During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. If the parents choose NCR over FCT for socially maintained challenging behavior, the investigators will deliver the functional and competing reinforcers on time-based schedules. If challenging behavior is found to be automatically maintained, the investigators will recommend using NCR with competing items and response blocking for treatment. The investigators will use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of these treatments.

干预措施: Functional Communication Training (FCT) (Behavioral)

Functional Analysis Treatment for Harmful Challenging Behavior

Experimental

If challenging behavior is found to be socially maintained, the investigators will recommend functional communication training (FCT) to teach a functional communication response (FCR) (e.g., touching a card with a picture of the participant consuming the reinforcer), but the investigators will also offer NCR as a potential treatment option to the caregivers. During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. If the parents choose NCR over FCT for socially maintained challenging behavior, the investigators will deliver the functional and competing reinforcers on time-based schedules. If challenging behavior is found to be automatically maintained, the investigators will recommend using NCR with competing items and response blocking for treatment. The investigators will use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of these treatments.

干预措施: Non-Contingent Reinforcement (NCR) (Behavioral)

Functional Analysis Treatment for Harmful Challenging Behavior

Experimental

If challenging behavior is found to be socially maintained, the investigators will recommend functional communication training (FCT) to teach a functional communication response (FCR) (e.g., touching a card with a picture of the participant consuming the reinforcer), but the investigators will also offer NCR as a potential treatment option to the caregivers. During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. If the parents choose NCR over FCT for socially maintained challenging behavior, the investigators will deliver the functional and competing reinforcers on time-based schedules. If challenging behavior is found to be automatically maintained, the investigators will recommend using NCR with competing items and response blocking for treatment. The investigators will use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of these treatments.

干预措施: Competing Items and Response Blocking (Behavioral)

Functional Analysis Treatment for Milder Challenging Behavior

Experimental

Caregivers of patients with mild challenging behavior will receive training using the Research Units in Behavioral Intervention (RUBI) protocol informed by the functional analysis conducted as a part of the initial assessment (Bearss et al., 2018). The RUBI protocol includes 11 core modules and 7 optional modules on training caregivers to apply behavior-analytic techniques to help manage challenging behaviors.

干预措施: Research Units in Behavioral Intervention (RUBI) protocol (Behavioral)

结局指标

主要结局

Rate of Problem Behavior

时间窗: 2 years

The investigators will collect continuous, direct-observation measures of destructive behavior throughout all phases of the study. They will compare rates of destructive behavior during assessment, treatment, caregiver training, and followup.

次要结局

  • Clinical Global Impressions Severity Subscale(2 years)
  • Caregiver report(2 years)
  • Aberrant Behavior Checklist Irritability Subscale(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne W. Fisher, Ph.D., BCBA-D, LP

Director of RUCARES and CSH-RUCARES/ Henry Rutgers Endowed Professor of Pediatrics

Rutgers, The State University of New Jersey

研究点 (2)

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