NCT07603986

Brief Summary

This pilot study evaluated whether cognitive behavioral therapy for anger and aggression, added to treatment as usual, was associated with reductions in irritability and suicidal ideation in preteen children with externalizing disorders. Children aged 8 to 12 years who were referred to an outpatient child psychiatry clinic for irritability, anger outbursts, or reactive aggression were assigned to CBT-AA plus treatment as usual or treatment as usual alone. The intervention included individual child sessions focused on emotion regulation, problem-solving, and social skills, with parent guidance sessions. Irritability and suicidal ideation were assessed at baseline, during treatment, at the end of treatment, and at follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

May 11, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Cognitive Behavioral TherapyIrritabilityPreteen ChildrenSuicidal IdeationSuicidal Behavior

Outcome Measures

Primary Outcomes (1)

  • Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13

    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.

    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.

Secondary Outcomes (3)

  • Change in Irritability Measured by the Affective Reactivity Index

    Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.

  • Change in Suicidal Ideation Severity Measured by the Columbia-Suicide Severity Rating Scale

    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.

  • Occurrence of Suicidal Behavior Measured by the Columbia-Suicide Severity Rating Scale

    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.

Study Arms (2)

Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU)

EXPERIMENTAL

Participants received cognitive behavioral therapy for anger and aggression in addition to treatment as usual.

Behavioral: Cognitive Behavioral Therapy for Anger and AggressionBehavioral: Treatment as Usual (TAU)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants received treatment as usual alone, including routine psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.

Behavioral: Treatment as Usual (TAU)

Interventions

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

Also known as: CBT-AA
Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU)

Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.

Also known as: TAU
Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU)Treatment as Usual (TAU)

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geha Mental Health Center

Petah Tikva, 49100, Israel

Location

Related Publications (8)

  • Sukhodolsky DG, Scahill L. Cognitive-behavioral therapy for anger and aggression in children. Guilford Press; 2012.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 38419494BACKGROUND
  • 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.

    PMID: 30293122BACKGROUND
  • 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.

    PMID: 22193671BACKGROUND
  • 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.

    PMID: 22574736BACKGROUND
  • 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.

    PMID: 38228758BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Cognitive Behavioral Therapymycophenolic adenine dinucleotideTherapeutics

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tomer Levy, MD

    Geha Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label). Participants and research staff were not blinded to treatment allocation. Therapists were not involved in outcome measurement. Outcomes were based primarily on parent- and child-report questionnaires, with suicidality assessed by research clinicians.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel treatment arms: cognitive behavioral therapy for anger and aggression plus treatment as usual, or treatment as usual alone. Initial allocation used a computerized randomization procedure with sequentially numbered, sealed opaque envelopes. Because of pragmatic outpatient clinic constraints, later assignments were determined by treatment capacity and order of referral rather than by participant clinical characteristics.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 22, 2026

Study Start

October 22, 2021

Primary Completion

August 4, 2024

Study Completion

February 10, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the published results may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and applicable institutional and ethics requirements. Data will not be publicly posted because the dataset includes sensitive pediatric mental health and suicidality information.

Shared Documents
ANALYTIC CODE
Time Frame
Beginning 6 months after publication and available for 5 years.
Access Criteria
De-identified individual participant data underlying the published results and analytic code may be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include a methodologically sound proposal and will be reviewed by the study investigators. Data sharing will be subject to applicable institutional approval, ethics requirements, and a data use agreement. Data will not be publicly posted because they include sensitive pediatric mental health and suicidality information.

Locations