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Background Children with callous‐unemotional (CU) traits are at high lifetime risk of antisocial behavior. It is unknown if treatments for disruptive behavior disorders are as effective for children with CU traits (DBD+CU) as those without (DBD‐only), nor if treatments directly reduce CU traits. Separate multilevel meta‐analyses were conducted to compare treatment effects on DBD symptoms for DBD+CU versus DBD‐only children and evaluate direct treatment‐related reductions in CU traits, as well as to examine moderating factors for both questions. Methods We systematically searched PsycINFO, PubMed, Cochran Library (Trials), EMBASE, MEDLINE, APA PsycNet, Scopus, and Web of Science. Eligible studies were randomized controlled trials, controlled trials, and uncontrolled studies evaluating child‐focused, parenting‐focused, pharmacological, family‐focused, or multimodal treatments. Results Sixty studies with 9,405 participants were included (Mage = 10.04, SDage = 3.89 years, 25.09% female, 44.10% racial/ethnic minority). First, treatment was associated with similar reductions in DBD symptoms for DBD+CU (SMD = 1.08, 95% CI = 0.45, 1.72) and DBD‐only (SMD = 1.01, 95% CI = 0.38, 1.64). However, DBD+CU started (SMD = 1.18, 95% CI = 0.57, 1.80) and ended (SMD = 0.73, p < .001; 95% CI = 0.43, 1.04) treatment with more DBD symptoms. Second, although there was no overall direct effect of treatment on CU traits (SMD = .09, 95% CI = −0.02, 0.20), there were moderating factors. Significant treatment‐related reductions in CU traits were found for studies testing parenting‐focused components (SMD = 0.21, 95% CI = 0.06, 0.35), using parent‐reported measures (SMD = 0.16, 95% CI = 0.04, 0.28), rated as higher quality (SMD = 0.26, 95% CI = 0.13, 0.39), conducted outside the United States (SMD = 0.19, 95% CI = 0.05, 0.32), and with less than half the sample from a racial/ethnic minority group (SMD = 0.15, 95% CI = 0.002, 0.30). Conclusions DBD+CU children improve with treatment, but their greater DBD symptom severity requires specialized treatment modules that could be implemented alongside parenting programs. Conclusions are tempered by heterogeneity across studies and scant evidence from randomized controlled trials.

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IntroductionIrritability is defined as a tendency towards anger in response to frustration. Clinically, impairing irritability is a significant public health problem. There is a need for mechanism-based psychotherapies targeting severe irritability as it manifests in the context of disruptive mood dysregulation disorder (DMDD). This study protocol describes a randomised multiple baseline design testing the preliminary efficacy of a new treatment, exposure-based cognitive-behavioral therapy for severe irritability in youth, which also integrates components of parent management training. We will investigate associations of this intervention with primary clinical measures, as well as ecological momentary assessment measures.Methods and analysisForty youth will be enrolled. Participants, aged 8–17 years, must present at least one of two core symptoms of DMDD: abnormal mood or increased reactivity to negative emotional stimuli, with severe impairment in one domain (home, school, peers) and moderate in another, or moderate impairment in at least two domains. Each participant is randomised to a 2-week, 4-week or 6-week baseline observation period, followed by 12 active treatment sessions. Clinical ratings are conducted at baseline, biweekly (clinician), weekly (parent/child) throughout treatment, post-treatment, and 3-month and 6-month follow-up (clinician). Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures. Secondary outcome measures include parent and child reports of irritability. Post hoc additional symptom measures include clinician, parent and self-ratings of depression, anxiety and overall functional impairment. Prospective, digitally based event sampling of symptoms is acquired for a week pre-treatment, mid-treatment and post-treatment. Based on our pathophysiological model of irritability implicating frustrative non-reward, aberrant threat processing and instrumental learning, we probe these three brain-based targets using functional MRI paradigms to assess target engagement.Ethics and disseminationThe research project and all related materials were submitted and approved by the appropriate Institutional Review Board (IRB) of the National Institute of Mental Health (NIMH).Trial registration numbersNCT02531893 and NCT00025935.