Objective To describe the psychometric properties of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) interview, which surveys additional disorders not assessed in prior K-SADS, contains improved probes and anchor points, includes diagnosis-specific impairment ratings, generates DSM-III-R and DSM-IV diagnoses, and divides symptoms surveyed into a screening interview and five diagnostic supplements. Method Subjects were 55 psychiatric outpatients and 11 normal controls (aged 7 through 17 years). Both parents and children were used as informants. Concurrent validity of the screen criteria and the K-SADS-PL diagnoses was assessed against standard self-report scales. Interrater ( n = 15) and test-retest ( n = 20) reliability data were also collected (mean retest interval: 18 days; range: 2 to 38 days). Results Rating scale data support the concurrent validity of screens and K-SADS-PL diagnoses. Interrater agreement in scoring screens and diagnoses was high (range: 93% to 100%). Test-retest reliability κ coefficients were in the excellent range for present and/or lifetime diagnoses of major depression, any bipolar, generalized anxiety, conduct, and oppositional defiant disorder (.77 to 1.00) and in the good range for present diagnoses of posttraumatic stress disorder and attention-deficit hyperactivity disorder (.63 to .67). Conclusion Results suggest the K-SADS-PL generates reliable and valid child psychiatric diagnoses. J. Am. Acad. Child Adolesc. Psychiatry , 1997, 36(7): 980–988.

Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): Initial Reliability and Validity Data

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

https://www.bmj.com/content/bmj/340/bmj.c869.full.pdf

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

Objective Autism spectrum disorders are now recognized to occur in up to 1% of the population and to be a major public health concern because of their early onset, lifelong persistence, and high levels of associated impairment. Little is known about the associated psychiatric disorders that may contribute to impairment. We identify the rates and type of psychiatric comorbidity associated with ASDs and explore the associations with variables identified as risk factors for child psychiatric disorders. Method A subgroup of 112 ten- to 14-year old children from a population-derived cohort was assessed for other child psychiatric disorders (3 months' prevalence) through parent interview using the Child and Adolescent Psychiatric Assessment. DSM-IV diagnoses for childhood anxiety disorders, depressive disorders, oppositional defiant and conduct disorders, attention-deficit/hyperactivity disorder, tic disorders, trichotillomania, enuresis, and encopresis were identified. Results Seventy percent of participants had at least one comorbid disorder and 41% had two or more. The most common diagnoses were social anxiety disorder (29.2%, 95% confidence interval [Cl)] 13.2-45.1), attention-deficit/hyperactivity disorder (28.2%, 95% Cl 13.3-43.0), and oppositional defiant disorder (28.1 %, 95% Cl 13.9-42.2). Of those with attention-deficit/hyperactivity disorder, 84% received a second comorbid diagnosis. There were few associations between putative risk factors and psychiatric disorder. Conclusions Psychiatric disorders are common and frequently multiple in children with autism spectrum disorders. They may provide targets for intervention and should be routinely evaluated in the clinical assessment of this group. J. Am. Acad. Child Adolesc. Psychiatry , 2008;47(8):921-929.

Psychiatric disorders in children with autism spectrum disorders: Prevalence, comorbidity, and associated factors in a population-derived sample

Objectives: The purposes of this study were to identify age-related changes in objectively recorded sleep patterns across the human life span in healthy individuals and to clarify whether sleep latency and percentages of stage 1, stage 2, and rapid eye movement (REM) sleep significantly change with age. Design: Review of literature of articles published between 1960 and 2003 in peer-reviewed journals and meta-analysis. Participants: 65 studies representing 3,577 subjects aged 5 years to 102 years. Measurement: The research reports included in this meta-analysis met the following criteria: (1) included nonclinical participants aged 5 years or older; (2) included measures of sleep characteristics by “all night” polysomnography or actigraphy on sleep latency, sleep efficiency, total sleep time, stage 1 sleep, stage 2 sleep, slow-wave sleep, REM sleep, REM latency, or minutes awake after sleep onset; (3) included numeric presentation of the data; and (4) were published between 1960 and 2003 in peer-reviewed journals. Results: In children and adolescents, total sleep time decreased with age only in studies performed on school days. Percentage of slow-wave sleep was significantly negatively correlated with age. Percentages of stage 2 and REM sleep significantly changed with age. In adults, total sleep time, sleep efficiency, percentage of slow-wave sleep, percentage of REM sleep, and REM latency all significantly decreased with age, while sleep latency, percentage of stage 1 sleep, percentage of stage 2 sleep, and wake after sleep onset significantly increased with age. However, only sleep efficiency continued to significantly decrease after 60 years of age. The magnitudes of the effect sizes noted changed depending on whether or not studied participants were screened for mental disorders, organic diseases, use of drug or alcohol, obstructive sleep apnea syndrome, or other sleep disorders. Conclusions: In adults, it appeared that sleep latency, percentages of stage 1 and stage 2 significantly increased with age while percentage of REM sleep decreased. However, effect sizes for the different sleep parameters were greatly modified by the quality of subject screening, diminishing or even masking age associations with different sleep parameters. The number of studies that examined the evolution of sleep parameters with age are scant among school-aged children, adolescents, and middle-aged adults. There are also very few studies that examined the effect of race on polysomnographic sleep parameters.

https://sites.oxy.edu/clint/physio/article/MetaAnalysisofQuantitativeSleepParametersFromChildhoodtoOldAgeOhayon2004.pdf

Meta-Analysis of Quantitative Sleep Parameters From Childhood to Old Age in Healthy Individuals: Developing Normative Sleep Values Across the Human Lifespan

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.

http://www.people.vcu.edu/~albest/Guidance/CONSORTjama.pdf

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

• The reliability of assessment of Research Diagnostic Criteria and DSM-III axis I affective disorders in children and adolescents was studied using a semistructured diagnostic interview. The Schedule for Affective Disorders and Schizophrenia (SADS) for School-Age Children (Kiddie SADS) Present Episode Version, an adaptation of the adult SADS for children was used. Fifty-two subjects, aged 6 through 17 years, were interviewed in a test-retest format by one of three pairs of interviewers. Assessment of symptoms and composite scales of the depressive syndrome were determined to have acceptable reliability, as were three depressive diagnoses. Conduct disorder was assessed with high reliability. Four anxiety disorders and their composite symptoms were assessed with unacceptable reliability; only separation anxiety was assessed with acceptable reliability. The results of this study showed generally lower reliability of symptoms, scales, and diagnoses than did two studies of adults using the SADS.

The Assessment of Affective Disorders in Children and Adolescents by Semistructured Interview: Test-Retest Reliability of the Schedule for Affective Disorders and Schizophrenia for School-Age Children, Present Episode Version

Objectives To review the historical development, reliability, validity, administrative characteristics, and uses of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). Method The various past and current K-SADS editions were reviewed as was the literature describing their uses. Results Three DSM-IV -compatible versions of the K-SADS are in general use, 1 present state (K-SADS-P IVR) and 2 epidemiological editions (K-SADS-E and K-SADS-P/L). All 3 interviews provide a current diagnostic assessment. The K-SADS-P IVR also evaluates the worst past episode during the preceding year, while the K-SADS-E and -P/L provide a lifetime diagnosis. The K-SADS-E and -P/L are primarily categorical diagnostic interviews while the K-SADS-P IVR, which also measures symptom severity, can be used to monitor treatment response. All editions have good rater reliability. However, the quality of the validating data set for the K-SADS is limiting. Conclusions The K-SADS is a viable interview schedule to assess current, past, and lifetime diagnostic status in children and adolescents. It is has the potential to further aide in the validation of psychiatric disorders. The substantial rater training required for reliable administration and the need for more validation work remain its drawbacks.

Historical Development and Present Status of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

• Symptom frequency and severity were compared in two sequential clinically referred samples of 95 children and 92 adolescents, aged 6 to 18 years, all medically healthy, assessed with the Schedule for Affective Disorders and Schizophrenia for School Age Children, Present Episode, who met unmodified Research Diagnostic Criteria for major depressive disorder (MDD). There were no significant differences between the two groups in the majority of depressive symptoms. However, prepubertal children had greater depressed appearance, somatic complaints, psychomotor agitation, separation anxiety, phobias, and hallucinations, whereas adolescents had greater anhedonia, hopelessness, hypersomnia, weight change, use of alcohol and illicit drugs, and lethality of suicide attempt, but not severity of suicidal ideation or intent. Adolescents with a duration of the depressive episode of two years or greater had significantly higher rates of suicidal ideation and intent, lethality, and number of suicide attempts than youngsters with depressive episodes of shorter duration. A principal components factor analysis of psychiatric symptoms was carried out in all 296 youngsters evaluated during the same period who met DSM-III criteria for any Axis I diagnosis. The majority had an affective disorder. Factors were quite similar for both adolescents and children and included an "endogenous" and an "anxious" factor, as in many studies of adult depression. In addition, three other factors were found: negative cognitions, appetite and weight changes, and a conduct factor. Suicidal ideation was a component of both the negative cognitions factor and the conduct factor. It is concluded that the similarities across school age in the phenomenology of MDD far outweigh the few differences and that, therefore, developmental changes across this age range, once assessment variance in this age group is controlled for, have only mild to moderate effects on the expression of a limited number of affective symptoms in youngsters with MDD.

The Clinical Picture of Major Depression in Children and Adolescents

ContextThe efficacy, safety, and tolerability of selective serotonin reuptake
inhibitors (SSRIs) in the treatment of adults with major depressive disorder
(MDD) are well established. Comparatively few data are available on the effects
of SSRIs in depressed children and adolescents.ObjectiveTo evaluate the efficacy and safety of sertraline compared with placebo
in treatment of pediatric patients with MDD.Design and SettingTwo multicenter randomized, double-blind, placebo-controlled trials
were conducted at 53 hospital, general practice, and academic centers in the
United States, India, Canada, Costa Rica, and Mexico between December 1999
and May 2001 and were pooled a priori.ParticipantsThree hundred seventy-six children and adolescents aged 6 to 17 years
with Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition–defined MDD of at least moderate severity.InterventionPatients were randomly assigned to receive a flexible dosage (50-200
mg/d) of sertraline (n = 189) or matching placebo tablets (n = 187) for 10
weeks.Main Outcome MeasuresChange from baseline in the Children's Depression Rating Scale–Revised
(CDRS-R) Best Description of Child total score and reported adverse events.ResultsSertraline-treated patients experienced statistically significantly
greater improvement than placebo patients on the CDRS-R total score (mean
change at week 10, –30.24 vs –25.83, respectively; P = .001; overall mean change, –22.84 vs –20.19, respectively; P = .007). Based on a 40% decrease in the adjusted CDRS-R
total score at study end point, 69% of sertraline-treated patients compared
with 59% of placebo patients were considered responders (P = .05). Sertraline treatment was generally well tolerated. Seventeen
sertraline-treated patients (9%) and 5 placebo patients (3%) prematurely discontinued
the study because of adverse events. Adverse events that occurred in at least
5% of sertraline-treated patients and with an incidence of at least twice
that in placebo patients included diarrhea, vomiting, anorexia, and agitation.ConclusionThe results of this pooled analysis demonstrate that sertraline is an
effective and well-tolerated short-term treatment for children and adolescents
with MDD.

https://jamanetwork.com/journals/jama/articlepdf/197174/JOC22408.pdf

Paul J. Ambrosini

Papers

The Assessment of Affective Disorders in Children and Adolescents by Semistructured Interview: Test-Retest Reliability of the Schedule for Affective Disorders and Schizophrenia for School-Age Children, Present Episode Version

Historical Development and Present Status of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

The Clinical Picture of Major Depression in Children and Adolescents

Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials.

Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder