Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

17. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

46

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: Cognitive Behavioral Therapy for Anger and Aggression
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
Andere Namen:
  • CBT-AA
Verhalten: Treatment as Usual (TAU)
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Andere Namen:
  • Tau
Aktiver Komparator: 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.
Verhalten: Treatment as Usual (TAU)
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Andere Namen:
  • Tau

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Irritability Measured by the Affective Reactivity Index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Geha Mental Health Center

Mitarbeiter

Chief Scientist, The Israel Ministry of Science

Ermittler

  • Hauptermittler: Tomer Levy, MD, Geha Mental Health Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Oktober 2021

Primärer Abschluss (Tatsächlich)

4. August 2024

Studienabschluss (Tatsächlich)

10. Februar 2025

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FDAAA 801

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

Beginning 6 months after publication and available for 5 years.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Cognitive Behavioral Therapy for Anger and Aggression

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Macedonia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren