Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (NCT01965184) | Clinical Trial Compass
CompletedNot Applicable
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
United States101 participantsStarted 2013-11-14
Plain-language summary
This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive behavior such as irritability, anger and aggression in children and adolescents. CBT will be compared to Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned (like the flip of a coin) to receive CBT or SPT. Participants will be also asked to complete functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks (recordings/images of brain activity) before and after treatment.
Who can participate
Age range
8 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Boys and girls, 8 to 16 years of age.
. T-Score \> 65 on the parent-rated Aggressive Behavior Scale of the Child Behavior Checklist (CBCL).
. Unmedicated or on stable medication for aggression, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.
. Children can speak English sufficiently enough to participate in CBT and study assessments.
. Children should have 1) no metal medical implants, 2) a body weight of less than 250 lbs. and 3) no claustrophobia. \[These are necessitated by the safety requirements of the fMRI.\]
. Children should be able to meet fMRI data quality requirements at baseline \[to enable pre- to post-treatment comparison.\]
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Overt Aggression Scale
Timeframe: basline (week 0)
2
Modified Overt Aggression Scale
Timeframe: midpoint (week 6)
3
Modified Overt Aggression Scale
Timeframe: endpoint (week 12)
4
Modified Overt Aggression Scale
Timeframe: follow up (3 months)
5
The Clinical Global Impression - Improvement Score
Timeframe: basline (week 0)
6
The Clinical Global Impression - Improvement Score
Timeframe: midpoint (week 6)
7
The Clinical Global Impression - Improvement Score
Timeframe: endpoint (week 12)
8
The Clinical Global Impression - Improvement Score
. Families can commute to the Yale Child Study Center in New Haven, CT for weekly visits.
Exclusion criteria
. IQ below 85.
. Children across various DSM diagnoses will be eligible for participation. However, significant levels of psychopathology that require immediate clinical attention such as severe depression or psychosis will be exclusionary because it will require alternative treatments.
. Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder, brain injury based on medical history which can interfere with participation in the study.
. Concurrent psychotherapy can continue, but CBT for aggression is exclusionary. Subjects will be asked not to initiate any new child psychotherapy during the study.