ABSTRACT. Objective. Increasing numbers of children in the United States (ie, ϳ200 children per 100 000 population) require intensive care annually, because of advances in pediatric therapeutic techniques and a changing spectrum of pediatric disease. These children are especially vulnerable to a multitude of short-and long-term negative emotional, behavioral, and academic outcomes, including a higher risk of posttraumatic stress disorder (PTSD) and a greater need for psychiatric treatment, compared with matched hospitalized children who do not require intensive care. In addition, the parents of these children are at risk for the development of PTSD, as well as other negative emotional outcomes (eg, depression and anxiety disorders). There has been little research conducted to systematically determine the effects of interventions aimed at improving psychosocial outcomes for critically ill children and their parents, despite recognition of the adverse effects of critical care hospitalization on the nonphysiologic well-being of patients and their families. The purpose of this study was to evaluate the effects of a preventive educational-behavioral intervention program, the Creating Opportunities for Parent Empowerment (COPE) program, initiated early in the intensive care unit hospitalization on the mental health/ psychosocial outcomes of critically ill young children and their mothers.Design. A randomized, controlled trial with follow-up assessments 1, 3, 6, and 12 months after hospitalization was conducted with 174 mothers and their 2-to 7-year-old children who were unexpectedly hospitalized in the pediatric intensive care units (PICUs) of 2 children's hospitals. The final sample of 163 mothers ranged in age from 18 to 52 years, with a mean of 31.2 years. Among the mothers reporting race/ethnicity, the sample included 116 white (71.2%), 33 African American (20.3%), 3 Hispanic (1.8%), and 2 Indian (1.2%) mothers. The mean age of the hospitalized children was 50.3 months. Ninetynine children (60.7%) were male and 64 (39.3%) were female. The major reasons for hospitalization were respiratory problems, accidental trauma, neurologic problems, and infections. Fifty-seven percent (n ؍ 93) of the children had never been hospitalized overnight, and none had experienced a previous PICU hospitalization.Interventions. Mothers in the experimental (COPE) group received a 3-phase educational-behavioral intervention program 1) 6 to 16 hours after PICU admission, 2) 2 to 16 hours after transfer to the general pediatric unit, and 3) 2 to 3 days after their children were discharged from the hospital. Control mothers received a structurally equivalent control program. The COPE intervention was based on self-regulation theory, control theory, and the emotional contagion hypothesis. The COPE program, which was delivered with audiotapes and matching written information, as well as a parent-child activity workbook that facilitated implementing the audiotaped information, focused on increasing 1) parents' knowledge and understanding of ...