RECRUITING

Manualized Assessment and Treatment Model of Challenging Behavior

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Manualized Assessment and Treatment Model of Challenging Behavior

Quick Facts

Study Start:2024-04-08

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05928247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. children from ages 3 to 17; 2. challenging behavior that occurs at least 10 times a day, despite previous treatment; 3. challenging behavior maintained by social positive or automatic reinforcement; 4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment; 5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free; 6. stable educational plan and placement with no anticipated changes during the child's treatment.	1. patients who do not meet the inclusion criteria; 2. patients currently receiving 15 or more hours per week of treatment for their challenging behavior; 3. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism); 4. a comorbid health condition or major mental disorder that would interfere with study participation; 5. 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); 6. 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.

Inclusion Criteria

Exclusion Criteria

1. children from ages 3 to 17;
2. challenging behavior that occurs at least 10 times a day, despite previous treatment;
3. challenging behavior maintained by social positive or automatic reinforcement;
4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment;
5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;
6. stable educational plan and placement with no anticipated changes during the child's treatment.

1. patients who do not meet the inclusion criteria;
2. patients currently receiving 15 or more hours per week of treatment for their challenging behavior;
3. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
4. a comorbid health condition or major mental disorder that would interfere with study participation;
5. 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);
6. 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.

Contacts and Locations

Study Contact

Wayne Fisher, PhD

CONTACT

8488008503

wayne.fisher@rutgers.edu

Serena Claiborne

CONTACT

8488008504

sclaibor@rutgers.edu

Study Locations (Sites)

Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services

Somerset, New Jersey, 08873

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-04-08

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Problem Behavior
Aggression
Self-Injury