Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (RDoC-CBT)

Yale University

Status: Completed

Conditions: Noncompliance; Aggression; Anger; Irritability; Disruptive Behavior

Treatments: Behavioral: Cognitive-Behavioral Therapy for Anger and Aggression; Behavioral: Supportive Psychotherapy (SPT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01965184

0102012121-C

R01MH101514 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Cognitive-Behavioral Therapy for Anger and Aggressive Behavior

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-Behavioral Therapy for Anger and Aggression

Supportive Psychotherapy (SPT)

Active Comparator group

Description:

SPT consists of 12 sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being

Treatment:

Behavioral: Supportive Psychotherapy (SPT)