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Disruptive Behavior | Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

Disruptive Behavior research study

What is the primary objective of this study?

This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive behavior such as 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. CBT is a behavioral intervention that consists of 12 one-hour long, 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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Disruptive Behavior

Aggression

Anger

Irritability

Noncompliance

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Cognitive-Behavioral Therapy for Aggression

Behavioral:Supportive Psychotherapy (SPT)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cognitive-Behavioral Therapy (CBT) for Aggressive BehaviorCBT is a behavioral intervention that consists of 12 one-hour long, 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.

Supportive Psychotherapy (SPT)SPT consists of 12 one-hour sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being

Study Status

Active, not recruiting

Start Date: November 14, 2013

Completed Date: December 1, 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The Clinical Global Impression - Improvement (CGI-I) Score

Secondary Outcome: The Child Behavior Checklist (CBCL)

Study sponsors, principal investigator, and references

Principal Investigator: Denis G. Sukhodolsky, Ph.D.

Lead Sponsor: Yale University

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT01965184

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