- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Petah Tikva, Israele, 49100
- Geha Mental Health Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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
Altri nomi:
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Irritability Measured by the Affective Reactivity Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Tomer Levy, MD, Geha Mental Health Center
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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- FDAAA 801
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