Scabies Infection While Expressing Human Milk for Critically Ill Infants: Is It Safe?

Background: Scabies infections of the breast in lactating individuals are not well described, especially how maternal infection can impact human milk feeding of hospitalized infants in the intensive care setting. Methods: This case report presents a critically ill female infant with a complex surgical history whose mother had an active scabies infection around the breast postpartum and wished to provide expressed human milk. Results: In this case report, human milk was recommended despite maternal scabies infection. Conclusion: Given the limited information that is known about the risk of scabies transmission in human milk for critically ill infants, this case adds to the knowledge base and supports the call for further research.

Awareness of the Maternal Health Benefits of Lactation Among U.S. Pregnant Individuals.

INTRODUCTION: We assessed awareness of the maternal health benefits of lactation among a sample of nulliparous pregnant individuals in the United States, identified variables associated with awareness of these benefits, and examined whether awareness of these benefits impacts breastfeeding attitudes or intentions. METHODS: We administered a web-based survey to nulliparous U.S.-born individuals carrying a singleton gestation of at least 28 weeks. We assessed awareness of the maternal health benefits of lactation using 10 items to create a summative score. We examined variation in awareness of these benefits by demographic characteristics, health insurance, and personal or family health history and used multivariable models to estimate associations between awareness of the maternal health benefits of lactation and breastfeeding intentions. RESULTS: Of the 675 individuals invited to complete surveys, 451 (67%) responded. Only 50% were aware that breastfeeding lowers maternal risk of breast cancer; fewer were aware that breastfeeding lowers the risk of ovarian cancer (35%), diabetes (27%), and hypertension and heart disease (26%). Awareness of the maternal benefits of lactation did not vary by age or race/ethnicity. However, significant regional variation was noted. In multivariable models, scores of awareness of the maternal health benefits of breastfeeding were significantly associated with intentions to breastfeed for at least 12 months (adjusted odds ratio, 1.23; 95% confidence interval, 1.11, 1.37). CONCLUSIONS: Efforts to increase awareness of the maternal health benefits of lactation are still needed. Increasing awareness of the maternal health benefits of lactation may strengthen intentions to breastfeed as recommended.

Prenatal Counseling on the Maternal Health Benefits of Lactation: A Randomized Trial.

Objective: To assess the effects of prenatal counseling about the maternal health benefits of lactation on postpartum knowledge, breastfeeding intentions, and infant feeding behaviors. Materials and Methods: We conducted a randomized trial with 411 nulliparous U.S.-born women carrying a singleton gestation. Participants were recruited online; after completing a baseline survey that assessed breastfeeding knowledge and intentions, participants were randomized to receive a 10-minute virtual counseling session about the benefits of breastfeeding or attention-control counseling about smoke-free homes. We collected data on breastfeeding knowledge, intentions, and infant feeding behaviors through 12 months postpartum and conducted an intention-to-treat analysis. Results: On enrollment, awareness of the maternal health benefits of lactation was similarly low in both study groups. Postpartum, participants who received this prenatal counseling intervention had significantly greater awareness that breastfeeding decreases maternal risk of breast cancer, ovarian cancer, diabetes, heart disease, and rheumatoid arthritis (p < 0.001 for all). On enrollment, intended duration of breastfeeding was similar between groups (10.1 months versus 9.7 months, p = 0.41). At 1-month postpartum, intended duration of breastfeeding had increased from baseline among those who received this counseling (+0.7 months versus -0.7 months among controls, p = 0.004); among intervention participants intended duration of breastfeeding decreased less at 3 (-0.8 versus -1.6, p = 0.18), 6 (-2.0 versus -3.0, p = 0.06), 9 (-2.8 versus -4.2, p = 0.03), and 12 months postpartum (-4.8 versus -6.2, p = 0.09). Rates of exclusive breastfeeding and any breastfeeding were similar between groups. Conclusion: Prenatal counseling on the maternal health benefits of lactation increases awareness of these maternal health benefits and extends intended duration of breastfeeding. ClinicalTrials.gov Identifier: NCT04601987.

Physician personal breastfeeding experience and clinical care of the breastfeeding dyad.

BACKGROUND: Prior research suggests that physicians' personal experience with breastfeeding may influence their attitudes toward breastfeeding. This phenomenon has not been explored in well-newborn care physician leaders, whose administrative responsibilities often include drafting and approval of hospital breastfeeding and formula supplementation policies. METHODS: We conducted a mixed-methods study, surveying physicians in the Better Outcomes through Research for Newborns (BORN) network. We examined physician attitudes toward recommending breastfeeding and their breastfeeding experience. Qualitative analysis was conducted on responses to the question: "How do you think your breastfeeding experience influences your clinical practice?" RESULTS: Of 71 participants, most (92%) had a very positive attitude toward breastfeeding with 75% of respondents reporting personal experience with breastfeeding. Of these, 68% had a very positive experience, 25% had a somewhat positive experience, and 6% had a neutral experience. Four themes emerged with respect to the effect of breastfeeding experience on practice: (1) empathy with breastfeeding struggles, (2) increased knowledge and skills, (3) passion for breastfeeding benefits, and (4) application of personal experience in lieu of evidence-based medicine, particularly among those who struggled with breastfeeding. CONCLUSIONS: Well-newborn care physician leaders reported positive attitudes about breastfeeding, increased support toward breastfeeding persons, and a perception of improved clinical lactation skills. Those who struggled with breastfeeding reported increased comfort with recommending formula supplementation to their own patients. Medical education about evidence-based breastfeeding support practices and provision of lactation support to physicians has the potential to affect public health through improved care for the patients they serve.

Adverse Childhood Experiences and Developmental Delay in Young US Children.

INTRODUCTION: Adverse childhood experiences (ACEs) are common and have been associated with poor developmental outcomes. We aimed to investigate the relationship between early ACE exposure, subsequent diagnosis of developmental delay, and receipt of developmental delay services by young children. In addition, we aimed to assess the impact of health-promoting behaviors such as breastfeeding and daily reading on these relationships. METHODS: In this cross-sectional analysis of nationally-representative data from the 2017-2018 National Survey of Children's Health, we examined the relationship between ACEs, prior breastfeeding, daily reading, and developmental delay diagnosis among 7837 children aged 3-5 years, using multivariate logistic regression to adjust for family, personal, and sociodemographic characteristics. RESULTS: We found a dose-dependent relationship between ACEs and developmental delay diagnosis; compared to those without ACEs, developmental delay was more common among those with either one ACE (aOR = 2.03, 95% CI 1.17-3.52) or two or more ACEs (aOR = 2.34, 95% CI 1.25-4.37). Neither breastfeeding (exclusively breastfed for 6 months vs. never breastfed aOR = 0.70, 95% CI 0.33-1.46) nor daily reading (no reading versus daily reading aOR = 1.15, CI 0.57-2.33) were associated with incidence of developmental delay among study participants. There was no significant difference in receipt of services intended to meet developmental needs between children with and without ACEs. DISCUSSION: Children with very early ACE exposure are at increased risk for diagnosis of developmental delay. Early screening for ACEs and developmental delay may mitigate the early developmental manifestations of ACE exposure in vulnerable children.

As poor developmental outcomes are related to ACEs, children aged 3­5 years should be routinely screened for ACE exposure. Although breastfeeding and daily reading have multiple benefits to children, they do not adequately mitigate the developmental delays associated with ACE exposure.

Using human-centered design to develop a nurse-to-family telehealth intervention for pediatric transfers.

Objective: To develop a nurse-to-family telehealth intervention for pediatric inter-facility transfers using the human-centered design approach. Methods: We conducted the inspiration and ideation phases of a human-centered design process from July 2022 to December 2022. For the inspiration phase, we conducted a qualitative cross-sectional case study design over 3 months. We used thematic analysis with the framework approach of parent and provider interviews. Five team members individually coded transcripts and then met to discuss memos, update a construct summary sheet, and identify emerging themes. The team adapted themes into "How Might We" statements. For the ideation phase, multidisciplinary stakeholders brainstormed solutions to the "How Might We" statements in a design workshop. Workshop findings informed the design of a nurse-to-family telehealth intervention, which was iteratively revised over 2 months based on stakeholder feedback sessions. Results: We conducted interviews with nine parents, 11 nurses, and 13 physicians. Four themes emerged supporting the promise of a nurse-to-family telehealth intervention, the need to effectively communicate the intervention purpose, the value of a user-friendly workflow, and the essentiality of ensuring that diverse populations equitably benefit from the intervention. "How Might We" statements were discussed among 22 total workshop participants. Iterative adaptations were made to the intervention until feedback from workshop participants and 67 other stakeholders supported no further improvements were needed. Conclusion: Human-centered design phases facilitated stakeholder engagement in developing a nurse-to-family telehealth intervention. This intervention will be tested in an implementation phase as a feasibility and pilot trial.

Understanding of Lactational Amenorrhea As a Contraceptive Method Among U.S. Pregnant Women.

Introduction: The lactational amenorrhea method (LAM) of postpartum contraception is more effective than typical use of condoms or birth control pills. However, LAM may be underutilized due to incomplete perinatal counseling. Methods: We compared perceptions of the effectiveness of postpartum contraceptives including LAM among U.S.-born nulliparous pregnant women recruited using social media for a trial (NCT04601987). We used descriptive statistics to summarize data. Results: Of 760 individuals screened, 627 were invited to participate, and 451 (72%) were enrolled. Most (81%) had a college degree; 79% intended to breastfeed for at least 1 month. Only 8% believed exclusive breastfeeding reduces the chance of pregnancy "a lot" within 6 months of delivery and 2% indicated that exclusive breastfeeding is typically more effective than birth control pills or condoms. Compared with those planning to use other postpartum contraceptives, the 17% of respondents who planned to use LAM were more likely to know that breastfeeding delays return of menses (84% versus 44%, p ≤ 0.0001) and provides protection from pregnancy until menses return (54% versus 22%, p ≤ 0.0001). Although 25% of those planning to use LAM believed exclusive breastfeeding reduces pregnancy risk by "a lot," only 5% thought LAM is more effective than birth control pills and only 9% thought that it is more effective than condoms. Conclusions/Implications: First-time U.S. mothers are often unaware of breastfeeding's effects on menses and fertility. Clinicians providing counseling about postpartum contraceptive options should include more information on LAM.

Nurse-to-family telehealth for pediatric transfers: protocol for a feasibility and pilot cluster randomized controlled trial.

BACKGROUND: Children presenting to emergency departments of community hospitals may require transfer to a children's hospital for more definitive care, but the transfer process can be distressing and burdensome to patients, families, and the healthcare system. Using telehealth to bring the children's hospital nurse virtually to the bedside of the child in the emergency department has the potential to promote family-centered care and minimize triage issues and other transfer-associated burdens. To explore the feasibility of the nurse-to-family telehealth intervention, we are conducting a pilot study. METHODS: This parallel cluster randomized controlled feasibility and pilot trial will randomize six community emergency departments to use either nurse-to-family telehealth (intervention) or usual care (control) for pediatric inter-facility transfers. All eligible children presenting to a participating site during the study period who require inter-facility transfer will be included. Eligibility requires that there be an English-speaking adult parent or guardian at the emergency department bedside. We will examine feasibility objectives that assess protocol assignment adherence, fidelity, and survey response rates. We will measure subject-level exploratory outcome data to test feasibility of data collection and to obtain effect size estimates; exploratory outcomes include family-centered care, family experience, parent acute stress, parent distress, and change in level of care. Additionally, we will conduct a mixed methods implementation evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. DISCUSSION: The findings from this trial will increase our understanding about nurse-to-family telehealth during pediatric transfers. The mixed methods implementation evaluation will provide relevant insight about the contextual factors that influence the implementation and rigorous evaluation of our intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05593900. First Posted: October 26, 2022. Last Update Posted: December 5, 2022.

Vaccination and treatment options for SARS-CoV2 infection affecting lactation and breastfeeding.

The COVID-19 pandemic has posed considerable challenges to the health of lactating individuals. Vaccination remains one of the most important strategies for prevention of moderate to severe COVID-19 infection and is associated with protective benefits for lactating individuals and their breastfed infants with overall mild side effects. The current recommendations for COVID-19 treatment in lactating individuals includes remdesivir and dexamethasone for hospitalized patients and Paxlovid® (nirmatrelavir + ritonavir) as outpatient treatment in those with mild disease. As the pandemic continues to evolve with new COVID-19 variants, alternative therapeutic options are potentially needed, and it is critical to include lactating individuals in research to evaluate the safety and efficacy of COVID-19 treatment options in this population.

Providing Low-Income Women With a Manual Pump: A Pilot Study.

OBJECTIVES: Low-income, first-time mothers generally breastfeed exclusively and, overall, for a shorter average duration than high-income, multiparous mothers. A potential barrier to breastfeeding success is access to a breast pump for home use. In this pilot study, we estimated the effect of providing a manual breast pump during birth hospitalization for home use on any/exclusive breastfeeding and investigated participant attitudes about manual pumps and their breastfeeding experiences. METHODS: Sixty low-income, first-time mothers were enrolled in a pilot randomized controlled trial. One-half received a manual breast pump and the other half received an attention control. Breastfeeding exclusivity, duration, and use of the manual pump were assessed at 6 and 12 weeks. Qualitative interviews regarding the breastfeeding experience were completed. Thirty-one women answered 13 questions that were then transcribed, coded, and grouped into themes. RESULTS: Participants who were randomized to manual breast pump receipt during birth hospitalization had increased manual pump use at 6 weeks (13/19 [68%] versus controls 5/17 [29%]), there was no effect of pump receipt on any nor exclusive breastfeeding at 12 weeks. In qualitative analysis of the overall breastfeeding experience, participants expressed a need for additional support and had conflicting attitudes regarding breastfeeding and the pumping experience. CONCLUSIONS: Manual breast pump receipt in hospital among low-income, first-time mothers did not affect breastfeeding exclusivity or duration. Participants reported that early and ongoing lactation support is essential. Strategies to improve breastfeeding outcomes low-income, first-time mothers are needed.

Racial Inequities in Breastfeeding Counseling Among Pregnant People Who Use Cannabis.

We examined how breastfeeding advice in the context of cannabis use differed by race and ethnicity. Data from the 2017-2018 PRAMS (Pregnancy Risk Assessment Monitoring System) survey were used to assess differences in breastfeeding guidance related to cannabis use among 1,213 individuals who self-reported cannabis use 3 months before or during pregnancy. A multivariable logistic regression model was specified to examine the extent to which the odds of receiving prenatal advice against breastfeeding if using cannabis differed by self-reported race and ethnicity. We found that non-Hispanic Black people were four times more likely than non-Hispanic White people to be advised against breastfeeding if using cannabis (adjusted odds ratio 4.1, 95% CI 2.1-8.2). Pregnant non-Hispanic Black people were disproportionately advised not to breastfeed if using cannabis.

Bonding, Relaxation, Separation, and Connection: Expressing Human Milk While Videoconferencing with the Hospitalized Premature Infant.

Background: Breast milk feeding is an essential component of safe and effective care of the hospitalized premature infant. There are numerous barriers that impact breast milk expression during a preterm infant's hospitalization. We aimed to explore the experience of using videoconferencing with one's hospitalized premature infant while expressing breast milk. Materials and Methods: We conducted a qualitative study using purposive sampling to recruit lactating parents of premature (<34 weeks) hospitalized infants. We conducted semistructured interviews using an interview guide with 14 open-ended questions regarding the breast milk expression experience. Data collection and analysis were performed iteratively and were analyzed using inductive thematic analysis with a constant comparative approach. Data were organized into themes. Interview recruitment was discontinued when thematic saturation was reached. Results: Seventeen participants completed the interviews and four themes were identified: (1) videoconferencing promotes bonding and connection with the hospitalized infant, (2) videoconferencing provides motivation to pump, (3) videoconferencing reminds participants of the realities of separation from their infant, and (4) videoconferencing connects the whole family to the hospitalized infant. Conclusions: Users of videoconferencing with their hospitalized neonate reported an improved pumping experience while expressing milk for their premature infant. Videoconferencing is also a tool that can connect the whole family to the infant. This study was registered at clinicaltrials.gov (clinicaltrials.gov Identifier: NCT03957941) under the title "FamilyLink and Breastfeeding."

Academy of Breastfeeding Medicine Clinical Protocol #2: Guidelines for Birth Hospitalization Discharge of Breastfeeding Dyads, Revised 2022.

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. The Academy of Breastfeeding Medicine recognizes that not all lactating individuals identify as women. Using gender-inclusive language, however, is not possible in all languages and all countries and for all readers. The position of the Academy of Breastfeeding Medicine (https://doi.org/10.1089/bfm.2021.29188.abm) is to interpret clinical protocols within the framework of inclusivity of all breastfeeding, chestfeeding, and human milk-feeding individuals.

Association of Maternal Confidence and Breastfeeding Practices in Hispanic Women Compared to Non-Hispanic White Women.

Understanding modifiable factors related to breastfeeding initiation and duration is critical to increase breastfeeding rates. Maternal parenting confidence is a modifiable factor whose association with breastfeeding duration has not previously been investigated. In a retrospective cohort of 1023 mother-infant dyads, the association between maternal confidence and breastmilk feeding at 6 and 12 months of age were analyzed. The association of breastmilk frequency categories and maternal confidence score at 6 and 12 months was examined using multinomial logistic regression stratified by race, ethnicity, and adjusted for gestational age. We found that breastmilk feeding frequency at 6 months was negatively associated with the maternal confidence score. After stratification by ethnicity, the association was no longer significant. There was no association between human milk feeding frequency at 12 months and maternal confidence score at 12 months. Our results demonstrate the need for additional research to identify modifiable factors to increase breastfeeding rates.

A riot on campus: The effects of social identity complexity on emotions and reparative attitudes after ingroup-perpetrated violence.

When a group commits a transgression, members who identify closely with the group often engage in defensive strategies in which they are less likely to experience guilt and shame in response to the transgression than are less identified group members. Subsequently, highly identified group members are often less willing to offer reparations to the injured parties. Because appropriate emotional responses and reparations are critical to community reconciliation, the present investigation examined whether social identity complexity-the degree to which individuals perceive their multiple social identities as interrelated-reduced these defensive responses. In the aftermath of a campus riot, emotional responses and reparative attitudes of undergraduate students were assessed. Results indicated that individuals who closely identified with the university were in fact capable of experiencing guilt and shame, but only if they also had complex social identities. A path model indicated that emotional responses, in turn, predicted willingness to provide reparations to the campus community. Accordingly, social identity complexity provides a new approach to understanding responses to ingroup-perpetrated violence.

Two routes toward optimism: how agentic and communal themes in autobiographical memories guide optimism for the future.

Autobiographical memories are particularly adaptive because they function not only to preserve the past, but also to direct our future thoughts and behaviours. Two studies were conducted to examine how communal and agentic themes of positive autobiographical memories differentially predicted the route from autobiographical memories to optimism for the future. Across two studies, results revealed that the degree to which participants focused on communal themes in their autobiographical memories predicted their experience of nostalgia. In turn, the experience of nostalgia increased participants' levels of self-esteem and in turn, optimism for the future. By contrast, the degree to which participants focused on agentic themes in their memories predicted self-esteem and optimism, operating outside the experience of nostalgia. These effects remained even after controlling for self-focused attention. Together, these studies provide greater understanding of the interrelations among autobiographical memory, self-concept, and time, and demonstrate how agency and communion operate to influence perceptions of one's future when thinking about the past.

Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.

OBJECTIVE: The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study. METHODS: TOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ). RESULTS: Of the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors. CONCLUSIONS: These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards. TRIAL REGISTRY: Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .

Risperidone added to parent training and stimulant medication: effects on attention-deficit/hyperactivity disorder, oppositional defiant disorder, conduct disorder, and peer aggression.

OBJECTIVE: In this study, we aimed to expand on our prior research into the relative efficacy of combining parent training, stimulant medication, and placebo (Basic therapy) versus parent training, stimulant, and risperidone (Augmented therapy) by examining treatment effects for attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD) symptoms and peer aggression, symptom-induced impairment, and informant discrepancy. METHOD: Children (6-12 years of age; N = 168) with severe physical aggression, ADHD, and co-occurring ODD/CD received an open trial of parent training and stimulant medication for 3 weeks. Participants failing to show optimal clinical response were randomly assigned to Basic or Augmented therapy for an additional 6 weeks. RESULTS: Compared with Basic therapy, children receiving Augmented therapy experienced greater reduction in parent-rated ODD severity (p = .002, Cohen's d = 0.27) and peer aggression (p = .02, Cohen's d = 0.32) but not ADHD or CD symptoms. Fewer children receiving Augmented (16%) than Basic (40%) therapy were rated by their parents as impaired by ODD symptoms at week 9/endpoint (p = .008). Teacher ratings indicated greater reduction in ADHD severity (p = .02, Cohen's d = 0.61) with Augmented therapy, but not for ODD or CD symptoms or peer aggression. Although both interventions were associated with marked symptom reduction, a relatively large percentage of children were rated as impaired for at least 1 targeted disorder at week 9/endpoint by parents (Basic 47%; Augmented 27%) and teachers (Basic 48%; Augmented 38%). CONCLUSION: Augmented therapy was superior to Basic therapy in reducing severity of ADHD and ODD symptoms, peer aggression, and symptom-induced impairment, but clinical improvement was generally context specific, and effect sizes ranged from small to moderate. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study); http://clinicaltrials.gov/; NCT00796302.

What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder?

OBJECTIVE: Although combination pharmacotherapy is common in child and adolescent psychiatry, there has been little research evaluating it. The value of adding risperidone to concurrent psychostimulant and parent training (PT) in behavior management for children with severe aggression was tested. METHOD: One hundred sixty-eight children 6 to 12 years old (mean age 8.89 ± 2.01 years) with severe physical aggression were randomized to a 9-week trial of PT, stimulant (STIM), and placebo (Basic treatment; n = 84) or PT, STIM, and risperidone (Augmented treatment; n = 84). All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder (n = 124) or conduct disorder (n = 44). Children received psychostimulant (usually Osmotic Release Oral System methylphenidate) for 3 weeks, titrated for optimal effect, while parents received PT. If there was room for improvement at the end of week 3, placebo or risperidone was added. Assessments included parent ratings on the Nisonger Child Behavior Rating Form (Disruptive-Total subscale was the primary outcome) and Antisocial Behavior Scale; blinded clinicians rated change on the Clinical Global Impressions scale. RESULTS: Compared with Basic treatment (PT + STIM [44.8 ± 14.6 mg/day] + placebo [1.88 mg/day ± 0.72]), Augmented treatment (PT + STIM [46.1 ± 16.8 mg/day] + risperidone [1.65 mg/day ± 0.75]) showed statistically significant improvement on the Nisonger Child Behavior Rating Form Disruptive-Total subscale (treatment-by-time interaction, p = .0016), the Nisonger Child Behavior Rating Form Social Competence subscale (p = .0049), and Antisocial Behavior Scale Reactive Aggression subscale (p = .01). Clinical Global Impressions scores were substantially improved for the 2 groups but did not discriminate between treatments (Clinical Global Impressions-Improvement score ≤2, 70% for Basic treatment versus 79% for Augmented treatment). Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment; other adverse events differed modestly from Basic treatment; weight gain in the Augmented treatment group was minor. CONCLUSIONS: Risperidone provided moderate but variable improvement in aggressive and other seriously disruptive child behaviors when added to PT and optimized stimulant treatment. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study), URL: http://clinicaltrials.gov, unique identifier: NCT00796302.