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CBT for Anger and Aggression in Children: a Pilot Study of Irritability and Suicidality

17 mai 2026 mis à jour par: Geha Mental Health Center

CBT for Anger and Aggression in Children: A Pilot Study of Irritability and Suicidality

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

46

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Petah Tikva, Israël, 49100
        • Geha Mental Health Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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
Autres noms:
  • CBT-AA
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Autres noms:
  • TU
Comparateur actif: 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.
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Autres noms:
  • TU

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Délai: 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.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Irritability Measured by the Affective Reactivity Index
Délai: Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
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.
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
Délai: 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.
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.
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
Délai: 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.
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.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Tomer Levy, MD, Geha Mental Health Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 octobre 2021

Achèvement primaire (Réel)

4 août 2024

Achèvement de l'étude (Réel)

10 février 2025

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

17 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

Beginning 6 months after publication and available for 5 years.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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