Clinical trial NCT01965184: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Official title: Using CBT to Examine Circuitry of Frustrative Non-reward in Aggressive Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Aggression
Anger
Irritability
Noncompliance
Keywords: child
cognitive behavioral therapy
CBT
aggression
disruptive behavior
treatment
frustrative non-reward
irritability
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-10-18
Enrollment: 101
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cognitive-behavioral therapy (CBT) is a behavioral intervention that consists of 12 weekly sessions. During CBT children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger provoking for their child. This study is conducted to examine whether reduction of behavioral problems including anger outbursts, irritability, aggression and noncompliance after CBT may be paralleled by changes in areas of the brain responsible for emotion regulation and social perception.

Eligibility criteria: Inclusion Criteria:

1. Boys and girls, 8 to 16 years of age.
2. T-Score \> 65 on the parent-rated Aggressive Behavior Scale of the Child Behavior Checklist (CBCL).
3. Unmedicated or on stable medication for aggression, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.
4. Children can speak English sufficiently enough to participate in CBT and study assessments.
5. Children should have 1) no metal medical implants, 2) a body weight of less than 250 lbs. and 3) no claustrophobia. \[These are necessitated by the safety requirements of the fMRI.\]
6. Children should be able to meet fMRI data quality requirements at baseline \[to enable pre- to post-treatment comparison.\]
7. Families can commute to the Yale Child Study Center in New Haven, CT for weekly visits.

Exclusion Criteria:

1. IQ below 85.
2. 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.
3. 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.
4. Concurrent psychotherapy can continue, but CBT for aggression is exclusionary. Subjects will be asked not to initiate any new child psychotherapy during the study.

Primary outcomes:
measure: Modified Overt Aggression Scale
timeFrame: basline (week 0)
measure: Modified Overt Aggression Scale
timeFrame: midpoint (week 6)
measure: Modified Overt Aggression Scale
timeFrame: endpoint (week 12)
measure: Modified Overt Aggression Scale
timeFrame: follow up (3 months)
measure: The Clinical Global Impression - Improvement Score
timeFrame: basline (week 0)
measure: The Clinical Global Impression - Improvement Score
timeFrame: midpoint (week 6)
measure: The Clinical Global Impression - Improvement Score
timeFrame: endpoint (week 12)
measure: The Clinical Global Impression - Improvement Score
timeFrame: follow up (3 months)
Secondary outcomes:
measure: The Child Behavior Checklist
timeFrame: basline (week 0)
measure: The Child Behavior Checklist
timeFrame: midpoint (week 6)
measure: The Child Behavior Checklist
timeFrame: endpoint (week 12)
measure: The Child Behavior Checklist
timeFrame: follow up (3 months)
Other outcomes:
measure: functional magnetic resonance imaging (fMRI)
timeFrame: baseline (week 0)
measure: Electroencephalography (EEG)
timeFrame: baseline (week 0)
measure: functional magnetic resonance imaging (fMRI)
timeFrame: endpoint (week 12)
measure: Electroencephalography (EEG)
timeFrame: endpoint (week 12)
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Denis G. Sukhodolsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sukhodolsky, D. G. & Scahill, L. (2012). Cognitive-behavioral therapy for anger and aggression in children. New York: Guilford Press.
citation: Sukhodolsky DG, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-421. doi: 10.1097/CHI.0b013e3181985050.
citation: Perlman SB, Pelphrey KA. Developing connections for affective regulation: age-related changes in emotional brain connectivity. J Exp Child Psychol. 2011 Mar;108(3):607-20. doi: 10.1016/j.jecp.2010.08.006. Epub 2010 Oct 23.