Psychological Treatments for Youth With Severe Irritability.

NCT02531893 | Recruiting

• 2 other identifiers: 15018215-M-0182
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD. Objective: To test two whether IBT and CBT can decrease severe irritability in children and youth. Eligibility: Children 8-17 years old with DMDD. Their symptoms must have started before age 10. Design: Participants will be screened with a review of their symptoms. Parents and participants will answer questions. Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT. Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions. Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable. Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews. Participants will do practice activities at home. Participants doing IBT will have up to 14 sessions over 10 weeks. Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home. Participants and parents answer questions about their progress.

Conditions

Irritability

Keywords

Interpretation Bias Training; Cognitive Behavioral Therapy; Children; Natural History

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impression--Improvement score

  Clinician administered measure to assess clinical symptoms

  Every two weeks

• Affective Reactivity Index (ARI)

  Clinician administered measure to assess clinical symptoms

  Every two weeks

Secondary Outcomes (1)

• parent and self-report measures of irritability, depression, anxiety, anger, social status, and aggression, as well as clinician ratings of depression, anxiety, and impairment

  Weekly

Study Arms (1)

Irritable youth

Participants meet full DMDD criteria for IBT and either full DMDD or one of two core DMDD criteria for CBT.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All outpatients, ages 8-17, enrolled in NIMH-DIRP Protocol 02-M-0021, and who are on stable, community treatment will be invited to participate in this study.

You may qualify if:

• Age 8-17 years
• Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.
• Must meet DSM 5 diagnostic criteria for DMDD which are (for CBT, must meet lifetime history of either DMDD or one of two core DMDD criteria \[b or c\]):
• Must meet all of the following:
• Diagnosis must first be made between ages 6-18 years
• Abnormal mood (specifically, anger and/or irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).
• Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week.
• The symptoms in b and c above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.
• The onset of symptoms must be prior to age 10 years.
• The symptoms are severe in at least one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (verbal aggression) in a second setting.
• Patients must be fluent in English
• All instruments have not been validated in other languages.
• Psychotherapy will be designed and conducted in English.
• On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more).
• Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.

You may not qualify if:

• The individual exhibits any of these cardinal bipolar symptoms:
• Elevated or expansive mood.
• Grandiosity or inflated self-esteem.
• Decreased need for sleep.
• Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).
• A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.
• Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.
• IQ\<70
• The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.
• Meets criteria for alcohol or substance abuse three months prior to enrollment.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (16)

• Leibenluft E. Severe mood dysregulation, irritability, and the diagnostic boundaries of bipolar disorder in youths. Am J Psychiatry. 2011 Feb;168(2):129-42. doi: 10.1176/appi.ajp.2010.10050766. Epub 2010 Dec 1.

  PMID: 21123313 BACKGROUND

• Leibenluft E, Stoddard J. The developmental psychopathology of irritability. Dev Psychopathol. 2013 Nov;25(4 Pt 2):1473-87. doi: 10.1017/S0954579413000722.

  PMID: 24342851 BACKGROUND

• Brotman MA, Kircanski K, Stringaris A, Pine DS, Leibenluft E. Irritability in Youths: A Translational Model. Am J Psychiatry. 2017 Jun 1;174(6):520-532. doi: 10.1176/appi.ajp.2016.16070839. Epub 2017 Jan 20.

  PMID: 28103715 BACKGROUND

• Naim R, German RE, White J, Pandya U, Dombek K, Clayton M, Perlstein S, Henry LM, Kircanski K, Lorenzo-Luaces L, Brotman MA. Treatment adherence, therapeutic alliance, and clinical outcomes during an exposure-based cognitive-behavioral therapy for pediatric irritability. BMC Psychiatry. 2025 Feb 26;25(1):181. doi: 10.1186/s12888-025-06601-0.

  PMID: 40012036 DERIVED

• Grasser LR, Erjo T, Goodwin MS, Naim R, German RE, White J, Cullins L, Tseng WL, Stoddard J, Brotman MA. Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol. BMC Psychiatry. 2023 Dec 11;23(1):926. doi: 10.1186/s12888-023-05421-4.

  PMID: 38082431 DERIVED

• Linke JO, Haller SP, Xu EP, Nguyen LT, Chue AE, Botz-Zapp C, Revzina O, Perlstein S, Ross AJ, Tseng WL, Shaw P, Brotman MA, Pine DS, Gotts SJ, Leibenluft E, Kircanski K. Persistent Frustration-Induced Reconfigurations of Brain Networks Predict Individual Differences in Irritability. J Am Acad Child Adolesc Psychiatry. 2023 Jun;62(6):684-695. doi: 10.1016/j.jaac.2022.11.009. Epub 2022 Dec 21.

  PMID: 36563874 DERIVED

• Haller SP, Archer C, Jeong A, Jaffe A, Jones EL, Harrewijn A, Naim R, Linke JO, Stoddard J, Brotman MA. Changes in Internalizing Symptoms During the COVID-19 Pandemic in a Transdiagnostic Sample of Youth: Exploring Mediators and Predictors. Child Psychiatry Hum Dev. 2024 Feb;55(1):206-218. doi: 10.1007/s10578-022-01382-z. Epub 2022 Jul 6.

  PMID: 35794298 DERIVED

• Haller SP, Stoddard J, Botz-Zapp C, Clayton M, MacGillivray C, Perhamus G, Stiles K, Kircanski K, Penton-Voak IS, Bar-Haim Y, Munafo M, Towbin KE, Brotman MA. A Randomized Controlled Trial of Computerized Interpretation Bias Training for Disruptive Mood Dysregulation Disorder: A Fast-Fail Study. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):37-45. doi: 10.1016/j.jaac.2021.05.022. Epub 2021 Jun 17.

  PMID: 34147585 DERIVED

• Naim R, Kircanski K, Gold A, German RE, Davis M, Perlstein S, Clayton M, Revzina O, Brotman MA. Across-subjects multiple baseline trial of exposure-based cognitive-behavioral therapy for severe irritability: a study protocol. BMJ Open. 2021 Mar 10;11(3):e039169. doi: 10.1136/bmjopen-2020-039169.

  PMID: 33692176 DERIVED

• Linke JO, Abend R, Kircanski K, Clayton M, Stavish C, Benson BE, Brotman MA, Renaud O, Smith SM, Nichols TE, Leibenluft E, Winkler AM, Pine DS. Shared and Anxiety-Specific Pediatric Psychopathology Dimensions Manifest Distributed Neural Correlates. Biol Psychiatry. 2021 Mar 15;89(6):579-587. doi: 10.1016/j.biopsych.2020.10.018. Epub 2020 Nov 9.

  PMID: 33386133 DERIVED

• Linke J, Kircanski K, Brooks J, Perhamus G, Gold AL, Brotman MA. Exposure-Based Cognitive-Behavioral Therapy for Disruptive Mood Dysregulation Disorder: An Evidence-Based Case Study. Behav Ther. 2020 Mar;51(2):320-333. doi: 10.1016/j.beth.2019.05.007. Epub 2019 May 21.

  PMID: 32138941 DERIVED

• Haller SP, Kircanski K, Stringaris A, Clayton M, Bui H, Agorsor C, Cardenas SI, Towbin KE, Pine DS, Leibenluft E, Brotman MA. The Clinician Affective Reactivity Index: Validity and Reliability of a Clinician-Rated Assessment of Irritability. Behav Ther. 2020 Mar;51(2):283-293. doi: 10.1016/j.beth.2019.10.005. Epub 2019 Nov 27.

  PMID: 32138938 DERIVED

• Cardinale EM, Kircanski K, Brooks J, Gold AL, Towbin KE, Pine DS, Leibenluft E, Brotman MA. Parsing neurodevelopmental features of irritability and anxiety: Replication and validation of a latent variable approach. Dev Psychopathol. 2019 Aug;31(3):917-929. doi: 10.1017/S095457941900035X. Epub 2019 May 8.

  PMID: 31064595 DERIVED

• Haller SP, Stoddard J, MacGillivray C, Stiles K, Perhamus G, Penton-Voak IS, Bar-Haim Y, Munafo MR, Brotman MA. A double-blind, randomized, placebo-controlled trial of a computer-based Interpretation Bias Training for youth with severe irritability: a study protocol. Trials. 2018 Nov 14;19(1):626. doi: 10.1186/s13063-018-2960-5.

  PMID: 30428909 DERIVED

• Stringaris A, Vidal-Ribas P, Brotman MA, Leibenluft E. Practitioner Review: Definition, recognition, and treatment challenges of irritability in young people. J Child Psychol Psychiatry. 2018 Jul;59(7):721-739. doi: 10.1111/jcpp.12823. Epub 2017 Oct 30.

  PMID: 29083031 DERIVED

• Brotman MA, Kircanski K, Leibenluft E. Irritability in Children and Adolescents. Annu Rev Clin Psychol. 2017 May 8;13:317-341. doi: 10.1146/annurev-clinpsy-032816-044941.

  PMID: 28482689 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Melissa A Brotman, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa A Brotman, Ph.D.

CONTACT

(301) 435-6645; melissa.brotman@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: August 25, 2015
• Study Start: November 17, 2015
• Primary Completion (Estimated): May 8, 2028
• Study Completion (Estimated): May 8, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04-16

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)