Status:
COMPLETED
Resurgence as Choice: Basic and Clinical Studies
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Utah State University
Conditions:
Problem Behavior
Self-injury
Eligibility:
All Genders
3-19 years
Phase:
NA
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 destruct...
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 behav...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \- 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).
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03423940
Start Date
June 28 2018
End Date
August 2 2023
Last Update
September 3 2024
Active Locations (1)
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1
Rutgers University Center for Autism Research, Education, and Services
Somerset, New Jersey, United States, 08840