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 range8 Years – 16 Years
SexALL
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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 \[to enable pre- to post-treatment comparison.\]
✓. 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.
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
. Concurrent psychotherapy can continue, but CBT for aggression is exclusionary. Subjects will be asked not to initiate any new child psychotherapy during the study.