IrritabilityNCT07603986
CBT for Anger and Aggression in Children: a Pilot Study of Irritability and Suicidality
A study testing Cognitive Behavioral Therapy for Anger and Aggression and Treatment as Usual (TAU) in people with Irritability and Anger, run by Geha Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Irritability, Anger, Externalizing Behavior
- What is being tested?
- Cognitive Behavioral Therapy for Anger and Aggression and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Oct 2021to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Cognitive Behavioral Therapy for Anger and Aggression, Treatment as Usual (TAU)
- Keywords
- Cognitive Behavioral Therapy, Irritability, Preteen Children, Suicidal Ideation, Suicidal Behavior
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Anger and AggressionBehavioural
Also called CBT-AA
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
Treatment as Usual (TAU)Behavioural
Also called TAU
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy for Anger and Aggression; Behavioral: 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. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 Oct 2021
- Primary completion4 Aug 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for IrritabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist, The Israel Ministry of Science
- Responsible party
- Sponsor
- Investigators
- Tomer Levy, MD, Principal investigator, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603986
- Sponsor's protocol ID
- FDAAA 801
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
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.
PubMed 38419494Benarous 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.
PubMed 30293122Posner 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.
PubMed 22193671Stringaris 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.
PubMed 22574736Dissanayake 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.
PubMed 38228758
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Anger and Aggression in Children: A Pilot Study of Irritability and Suicidality
- ClinicalTrials.gov ID
- NCT07603986
- Acronym / sponsor ID
- FDAAA 801
- Keywords
- Cognitive Behavioral Therapy, Irritability, Preteen Children, Suicidal Ideation, Suicidal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Collaborators
- Chief Scientist, The Israel Ministry of Science
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU) | Experimental | Behavioral: Cognitive Behavioral Therapy for Anger and Aggression, Behavioral: Treatment as Usual (TAU)Participants received cognitive behavioral therapy for anger and aggression in addition to treatment as usual. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Anger and AggressionAlso: CBT-AAProtocol-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 | Behavioural | Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU) |
| Treatment as Usual (TAU)Also: TAURoutine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic. | Behavioural | Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU), Treatment as Usual (TAU) |
Primary outcome
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
Time frame: 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.
3 secondary outcomes
Change in Irritability Measured by the Affective Reactivity Index
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- BackgroundSukhodolsky DG, Scahill L. Cognitive-behavioral therapy for anger and aggression in children. Guilford Press; 2012.
- BackgroundSukhodolsky 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
- BackgroundSukhodolsky 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: PubMed 38419494Leibenluft 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.
- Background: PubMed 30293122Benarous 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.
- Background: PubMed 22193671Posner 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.
- Background: PubMed 22574736Stringaris 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.
- Background: PubMed 38228758Dissanayake 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomer Levy, MD principal investigator
Geha Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Anger and Aggression and Treatment as Usual (TAU) in people with Irritability and Anger, run by Geha Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603986, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.