- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603986
CBT for Anger and Aggression in Children: a Pilot Study of Irritability and Suicidality
CBT for Anger and Aggression in Children: A Pilot Study of Irritability and Suicidality
Study Overview
Status
Intervention / Treatment
Detailed Description
This was a partially randomized, pragmatic pilot study conducted in a child psychiatric outpatient clinic at Geha Mental Health Center in Israel. The study included children aged 8 to 12 years with externalizing disorders, including ADHD, oppositional defiant disorder, intermittent explosive disorder, disruptive mood dysregulation disorder, or conduct disorder, who were referred because of clinically significant irritability and/or reactive aggression.
Participants were assigned to cognitive behavioral therapy for anger and aggression plus treatment as usual or to treatment as usual alone. During the initial treatment cycle, allocation was conducted using a computerized randomization procedure with sequentially numbered, sealed opaque envelopes and stratification by recent suicidal ideation or suicidal behavior. In later treatment cycles, assignment was constrained by therapist availability and scheduling within the outpatient service. For these later assignments, participants were allocated according to treatment capacity and order of referral rather than by participant clinical characteristics.
CBT-AA was delivered as an individual, in-person, protocol-based treatment. The intervention focused on three main domains: emotion regulation, social problem-solving, and social skills. Treatment as usual consisted of routine psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
The primary outcome was irritability, assessed with the Irritability and Dysregulation of Emotions Questionnaire-13 and the Affective Reactivity Index. Secondary outcomes included suicidal ideation and suicidal behavior assessed using the Columbia-Suicide Severity Rating Scale. Assessments were conducted at baseline, after treatment modules, at the end of treatment, and during follow-up.
The study was approved by the Institutional Helsinki Committee of Geha Mental Health Center. This record is being submitted retrospectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Petah Tikva, Israel, 49100
- Geha Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child age 8 to 12 years
- Parent or guardian able to read and write in Hebrew
- Receiving care in the Geha outpatient child and adolescent clinics
- Clinical diagnosis of ADHD, oppositional defiant disorder, intermittent explosive disorder, disruptive mood dysregulation disorder, or conduct disorder
- Irritability and/or reactive aggression as the reason for treatment seeking
Exclusion Criteria:
- Psychotic disorder or bipolar disorder
- Substance use
- Autism spectrum disorder
- IQ score less than 75 or clinical diagnosis of intellectual disability
- Immediate suicide risk requiring hospitalization as determined by the referring clinician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU)
Participants received cognitive behavioral therapy for anger and aggression in addition to treatment as usual.
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Protocol-based individual cognitive behavioral therapy for anger and aggression delivered in person in an outpatient child psychiatry clinic.
The intervention included three treatment modules: emotion regulation, social problem-solving, and social skills.
The emotion regulation module focused on recognizing anger triggers, monitoring emotional intensity, labeling emotions, identifying bodily signs of anger, and using strategies to reduce physiological arousal.
The social problem-solving module focused on interpreting social cues, considering other perspectives, generating alternative responses, and managing the effect of anger on thinking and decision-making.
The social skills module focused on assertiveness, prosocial responses to interpersonal conflict, role-play, guided practice, and generalization of skills to daily situations.
Parent guidance sessions were included, and parents were briefed by therapists during the treatment process.
The intervention was delivered in addition to t
Other Names:
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Other Names:
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Active Comparator: Treatment as Usual (TAU)
Participants received treatment as usual alone, including routine psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
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Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Time Frame: Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Irritability was assessed using the Irritability and Dysregulation of Emotions Questionnaire-13.
Parent-report and child-report versions were administered.
Items are rated on a 7-point Likert scale from -3 to +3, and summary scores were calculated as the mean of completed items.
Higher scores indicate greater irritability.
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Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Irritability Measured by the Affective Reactivity Index
Time Frame: Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Irritability was assessed using the Affective Reactivity Index.
Parent-report and child-report versions were administered.
Items are rated on a 3-point Likert scale, and summary scores were calculated as the mean of completed items.
Higher scores indicate greater irritability.
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Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Change in Suicidal Ideation Severity Measured by the Columbia-Suicide Severity Rating Scale
Time Frame: Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Suicidal ideation severity was assessed for the relevant C-SSRS reference period at each assessment.
The primary suicidal ideation analysis used baseline, end of treatment, 1-month follow-up, and 3-month follow-up assessments.
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Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Occurrence of Suicidal Behavior Measured by the Columbia-Suicide Severity Rating Scale
Time Frame: Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Suicidal behavior was assessed using the Columbia-Suicide Severity Rating Scale.
Suicidal behavior was coded as present if a suicide attempt, interrupted attempt, or aborted attempt was reported by either the parent or the child during the assessment period.
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Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tomer Levy, MD, Geha Mental Health Center
Publications and helpful links
General Publications
- Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10.
- Leibenluft E, Allen LE, Althoff RR, Brotman MA, Burke JD, Carlson GA, Dickstein DP, Dougherty LR, Evans SC, Kircanski K, Klein DN, Malone EP, Mazefsky CA, Nigg J, Perlman SB, Pine DS, Roy AK, Salum GA, Shakeshaft A, Silver J, Stoddard J, Thapar A, Tseng WL, Vidal-Ribas P, Wakschlag LS, Stringaris A. Irritability in Youths: A Critical Integrative Review. Am J Psychiatry. 2024 Apr 1;181(4):275-290. doi: 10.1176/appi.ajp.20230256. Epub 2024 Feb 29.
- Sukhodolsky DG, Scahill L. Cognitive-behavioral therapy for anger and aggression in children. Guilford Press; 2012.
- Sukhodolsky DG, Golub A, Stone EC, Orban L. Dismantling anger control training for children: A randomized pilot study of social problem-solving versus social skills training components. Behavior Therapy. 2005;36(1):15-23. doi:10.1016/S0005-7894(05)80050-4
- Sukhodolsky DG, Kassinove H, Gorman BS. Cognitive-behavioral therapy for anger in children and adolescents: A meta-analysis. Aggression and Violent Behavior. 2004;9(3):247-269. doi:10.1016/j.avb.2003.08.005
- Benarous X, Consoli A, Cohen D, Renaud J, Lahaye H, Guile JM. Suicidal behaviors and irritability in children and adolescents: a systematic review of the nature and mechanisms of the association. Eur Child Adolesc Psychiatry. 2019 May;28(5):667-683. doi: 10.1007/s00787-018-1234-9. Epub 2018 Oct 6.
- Dissanayake AS, Dupuis A, Arnold PD, Burton CL, Crosbie J, Schachar RJ, Levy T. Is irritability multidimensional: Psychometrics of The Irritability and Dysregulation of Emotion Scale (TIDES-13). Eur Child Adolesc Psychiatry. 2024 Aug;33(8):2767-2780. doi: 10.1007/s00787-023-02350-1. Epub 2024 Jan 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDAAA 801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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