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Objective: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents., Method: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations., Results: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim., Conclusions: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties.

The objective of the study was to determine whether the frequency and severity of sleep problems were greater in children of affectively ill mothers than in children of control mothers. Sleep problems were studied in children of mothers with a diagnosis of unipolar (N = 38) and bipolar (N = 23) affective illness and children of mothers with no current or past psychiatric diagnosis (N = 24). Mothers' reports on the Child Behavior Checklist (CBCL) were obtained three times, 4 years apart, on sibling pairs (ages 1.5-3.5 and 5-8 years, respectively, at first assessment). In addition, on the third assessment, the Diagnostic Interview for Children and Adolescents was filled out by mothers and children. In both siblings, sleep problems, as assessed through the CBCL, were more frequent and severe in children of affectively ill mothers. In younger siblings, the persistence of sleep problems was more frequent in children of affectively ill mothers. Co-occurrence of sleep problems among siblings was more frequent in children of affectively ill mothers than in those of control mothers.

Family, dyadic, and individual functioning were examined in 18 control families and 41 families with a history of maternal affective illness-including 26 in which husbands also had a history of psychiatric illness. Assessments of functioning, based on observed family interactions, indicated that families with a history of affective illness are more likely to have functional problems, and that problems may differ as a function of type of diagnosis and number of ill parents. Findings suggest that clinical program planning should take into account variability within groups, as well as individual competencies.

The expressed affect of clinically depressed and nondepressed mothers as measured by the Schedule for Affective Disorders and Schizophrenia: Lifetime Version (SADS-L) and their children (1 1/2 to 3 1/2 years) was observed in seminatural situations. The objectives were to investigate how maternal depression enters into affective interactions between mother and child and how the affect patterns of mother and child are related. Forty-nine unipolar and 24 bipolar depressed mothers and 45 nondepressed mothers were observed on 2 days, 2 weeks apart, for a total of 5 h. Each minute was coded for the predominant affect of mother and child. Affects relevant to depression (anxious--said, irritable--angry, downcast, pleasant, tender-affectionate) were coded. Depressed mothers expressed significantly more negative affect than did control mothers. Mothers' expressed affect and their self-reports of affect on days of observation were unrelated. Mother's and child's affects, measured on different days, were significantly correlated. Unipolar mothers and mothers severely depressed spent significantly more time in prolonged bouts of negative affect. There was significant synchrony between their bouts and the negative bouts of their daughters. Gender of child was related to mother's and child's affect, and to relations between mother's and child's affect.

Earlier research suggests that the natural verbal discourse of mothers with their children can be important in clarifying, verifying, and evaluating the behavior in which a child is engaged, in attributing qualities to the child, and in influencing the child's self-perceptions. We investigated the potential influences of parental affective illness (bipolar affective disorder and unipolar depression in contrast to no history of psychiatric illness) on such "labeling" behavior in a sample of 61 mothers and their older (school-age) and younger (preschool-age) children. It was hypothesized that the dispositions characterizing affective illness (specifically, negativity and disengagement) would be reflected in the labeling statements of mothers with a diagnosis as they interacted with their children. Based on videotaped interactions during a visit to a home-like laboratory apartment, labeling statements were identified in terms of speaker and person being labeled ("addressee") and coded (positive, negative, mixed, or neutral) for judgmental and affective quality of the statement and reaction of the addressee. Data were analyzed (a) by family unit and (b) my mother to child statements. The general pattern of findings indicated, in relative terms, an excess of negativity on the part of family members in the bipolar group and a dearth of negative affect for mothers in the unipolar group. Negativity in the bipolar group appeared to be especially likely when the setting involved mothers and two male children. Additionally, findings are discussed in terms of sex differences in vulnerability to depression.

The course of social-emotional development of young children of affectively ill and well parents was assessed. The families were classified by mother's diagnosis: bipolar illness (N = 22), unipolar depression (N = 41), and normal (N = 37). Father's diagnosis also was obtained. Pairs of siblings were studied; the younger was between 1 1/2 and 3 1/2 years and the older between 5 and 8 years when the study began. They were seen again 3 years later. Psychiatric assessment and mother's report were used to evaluate children's disruptive behavior, anxiety, and depressive characteristics. The frequency of problem-level behavior changed over time in relation to mother's diagnosis. By middle and late childhood, significantly more children of affectively ill than well mothers had depressive and disruptive problems and multiple behavior problems. Offspring of unipolar mothers developed problems earlier and both siblings were more likely to have behavior problems.

Gonadal and adrenal hormone levels appear to be linked to the stressors experienced by young adolescents. Adjustment problems were accompanied by a profile of lower gonadal steroids and higher adrenal androgen levels, primarily androstenedione. Later gonadal maturation may be a result of stress suppressing the reproductive axis. Higher levels of androstenedione may be indicative of chronic levels of stress. However, the findings for androstenedione are complicated by the fact that androstenedione was related to cortisol only in males. Furthermore, androstenedione as a weak androgenic has low potential for affecting behavior, directly. Cortisol levels were related to the frequency of distress behavior in a challenging situation. The relations disappeared with experience in the setting. These findings are consistent with prior animal and human studies. However, while distress behavior in a challenging situation decreased over the one-year period, cortisol levels did not. Sustained physiological arousal in a challenging situation may have long-term implications for the mental health of adolescents. A question for further exploration is whether individual differences in reactivity in one challenging situation, like the clinic visit, is predictive of reactivity in other settings. Adolescence appears to be an ideal period of development in which to examine the interactions between environmental and physiological causes and sequelae of stress. It is characterized by measurable changes in hormonal status and physical maturation and behavior. Studying the intricate interactions between these two sets of changes has only just begun. A larger question yet to be examined is whether interaction between hormones and behavior are unique to adolescence or whether they are indicative of hormone-behavior processes characteristic of the entire life-span. Adjustment and social stressors, adrenal activation, and reproductive maturation may constitute a "vicious" cycle of interrelated factors during adolescence. Adjustment problems could cause activation of the adrenal glands which would cause gonadal suppression and later maturation. The latter could constitute an added stressor reentering the cycle and potentiating the "abnormality". In our population of normal adolescents, this cycle is obviously active within a normal range. In these adolescents stress arising from either endogenous or exogenous sources was not a debilitating force. Rather, they fell within a normal range with various degrees of adjustment, adrenal activation and gonadal maturation.(ABSTRACT TRUNCATED AT 400 WORDS)

Cross-sectional data are presented on 108 young adolescents (56 boys, 52 girls), ages 9 to 14 years. The measures were: for all subjects, pubertal stage (Tanner criteria for genital/breast and pubic hair stage); height and weight; serum hormone concentrations for gonadotropins (luteinizing hormone and follicle-stimulating hormone), sex steroids (testosterone, estradiol, and the computed testosterone to estradiol ratio), adrenal androgens (dehydroepiandrosterone, dehydroepiandrosterone sulfate, and androstenedione), and testosterone-estradiol binding globulin. In addition, testicular volume for boys and menarchial status for girls are reported. The study goal was to provide interrelations among these measures, based on the same sample, and examine their interchangeability. Results suggest that it would be reasonable to compare research across as well as within studies based on different markers. Multiple regression analysis showed that the strongest hormone correlates of pubertal development were androgen levels (primarily testosterone in boys and primarily dehydroepiandrosterone sulphate and androstenedione in girls). Estradiol level in girls was the strongest correlate only for menarchial status. Level of testosterone-estradiol binding globulin, which was lower at successive pubertal stages for boys and showed no consistent differences for girls, may be a useful measure for studying the developmental processes and gender differences during puberty.

The relationship between performance and off-task behavior was examined as a function of childrens anxiety level in a clearly evaluative situation. 48 fourth-and fifth-grade boys and girls (assigned to low, middle, and high anxiety groups by their scores on the Test Anxiety Scale for Children) performed anagram tasks in the presence of an experimenter also working on anagrams. Frequency and direction of off-task glancing were used as measures of off-task behavior. As expected, both performance and off-task glancing were related to anxiety: high-anxious children hag than low- and middle-anxious children. It was proposed that anxious children's history of failure makes them more sensitive to and highly reliant on external feedback and evaluation and less likely to solve problems on their own. It was suggested that the performance of these children, who typically have greater ability than they show in evaluative situations, may be improved by increasing their on-task orientation through task-inherent and task-related feedback.

Relations among hormone levels, emotional dispositions, and aggressive attributes were examined in 56 boys and 52 girls, age 9 to 14 years. The adolescents represented all 5 stages of pubertal development. Serum levels of gonadotropins, gonadal steroids, adrenal androgens, and testosterone-estradiol binding globulin were assessed. Levels of these hormones were related to stage of pubertal development and were assumed to represent relatively stable biological characteristics. The emotional dispositions assessed were adolescent self-reported anger, nervousness, sadness, and impulse control. The aggressive attributes assessed were mother-reported acting out and aggressive behavior problems and rebellious and nasty characteristics. Hormone levels were related to emotional dispositions and aggressive attributes for boys but not for girls. For example, higher levels of androstenedione in boys were related to higher levels of acting-out behavior problems. Level of testosterone-estradiol binding globulin was negatively related to sad affect and acting out behavior.