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New treatment option for Problem Behavior
Official title Extensions of Resurgence as Choice
ClinicalTrials.gov ID: NCT05537610
What this study is testing
- What it's testing
- Although behavioral treatments for decreasing destructive behavior, such as differential reinforcement of alternative behavior (DRA), are effective in the clinic, problem behavior often returns when a caregiver does not give the child their way in the natural environment (e.g., caregiver is busy with an infant sibling). This form of treatment relapse is known as resurgence.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17. Healthy volunteers may be eligible.
You may be able to join if
- boys and girls from ages 3 to 17;
- problem behavior that occurs at least 10 times a day, despite previous treatment;
- problem behavior maintained by social positive 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;
You likely can't join if
- patients who do not meet the inclusion criteria;
- patients currently receiving 15 or more hours per week of treatment for their problem 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...
- patients requiring changes to protective supports for self-injury or drug treatment, but we will invite these patients to participate when protective...
See the full eligibility criteria
- boys and girls from ages 3 to 17;
- problem behavior that occurs at least 10 times a day, despite previous treatment;
- problem behavior maintained by social positive 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.
- patients who do not meet the inclusion criteria;
- patients currently receiving 15 or more hours per week of treatment for their problem 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;
- patients requiring changes to protective supports for self-injury or drug treatment, but we will invite these patients to participate when protective supports and drug regimen are stable.
The study team makes the final eligibility decision.
Where it's taking place
- Somerset, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Somerset, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.