CBT for Anger and Aggression in Children: a Pilot Study of Irritability and Suicidality
17. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Petah Tikva, Israel, 49100
- Geha Mental Health Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Andre navne:
|
|
Aktiv 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.
|
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Irritability Measured by the Affective Reactivity Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tomer Levy, MD, Geha Mental Health Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. oktober 2021
Primær færdiggørelse (Faktiske)
4. august 2024
Studieafslutning (Faktiske)
10. februar 2025
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
17. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FDAAA 801
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Beginning 6 months after publication and available for 5 years.
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .