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OBJECTIVE: To enhance the quality of care and clinical outcomes for children and adolescents with major depressive disorder (MDD) and persistent depressive disorder (PDD). The aims are as follows: (1) to summarize empirically based guidance about the psychosocial and psychopharmacologic treatment of MDD and PDD in children and adolescents; and (2) to summarize expert-based guidance about the assessment of these disorders as an integral part of treatment, and the implementation of empirically based treatments for these disorders in clinical practice. METHOD: Statements about the treatment of MDD and PDD are based upon empirical evidence derived from a critical systematic review of the scientific literature conducted by the Research Triangle Institute International-University of North Carolina at Chapel Hill (RTI-UNC) Evidence-based Practice Center under contract with the Agency for Healthcare Research and Quality (AHRQ). Evidence from meta-analyses published since the AHRQ/RTI-UNC review is also presented to support or refute the AHRQ findings. Guidance about the assessment and clinical implementation of treatments for MDD and PDD is informed by expert opinion and consensus as presented in previously published clinical practice guidelines, chapters in leading textbooks of child and adolescent psychiatry, the DSM-5-TR, and government-affiliated prescription drug information websites. RESULTS: Psychotherapy (specifically, cognitive-behavioral and interpersonal therapies) and selective serotonin reuptake inhibitor (SSRI) medication have some rigorous (randomized controlled trials, meta-analyses) empirical support as treatment options. Because effective treatment outcomes are predicated in part upon accuracy of the diagnosis, depth of the clinical formulation, and breadth of the treatment plan, comprehensive, evidence-based assessment may enhance evidence-based treatment outcomes. CONCLUSION: Disproportionate to the magnitude of the problem, there are significant limitations in the quality and quantity of rigorous empirical support for the etiology, assessment, and treatment of depression in children and adolescents. In the context of a protracted severe shortage of child and adolescent-trained behavioral health specialists, the demonstration of convenient, efficient, cost-effective, and user-friendly delivery mechanisms for safe and effective treatment of MDD and PDD is a key research need. Other research priorities include the sequencing and comparative effectiveness of depression treatments, delineation of treatment mediators and moderators, effective approaches to treatment nonresponders and disorder relapse/recurrence, long-term effects and degree of suicide risk with SSRI use, and the discovery of novel pharmacologic or interventional treatments.
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Antidepresivos , Trastorno Depresivo Mayor , Adolescente , Niño , Humanos , Antidepresivos/uso terapéutico , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/tratamiento farmacológico , Psicoterapia , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Resultado del TratamientoRESUMEN
Adolescent Substance Use DisordersSubstance use disorders contribute to the leading causes of death among adolescents, including homicide and suicide. Here, Simon et al. review the most recent published data on adolescent substance use disorders and the implications for clinical practice.
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Measurement-based care in adolescent substance use is an important element of the evidence-based framework of Screening, Brief Intervention, and Referral to Treatment (SBIRT). Use of a validated measure for detecting substance use, misuse, and substance use disorders is significantly more effective than the use of unvalidated tools or clinician intuition. There are now a variety of established and new validated screening tools that are available for use with adolescents and that capture the range of adolescent substance use behaviors. This area, however, continues to evolve rapidly.
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Práctica Clínica Basada en la Evidencia , Tamizaje Masivo , Derivación y Consulta , Trastornos Relacionados con Sustancias , Adolescente , Humanos , Psicometría , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/terapia , Encuestas y CuestionariosRESUMEN
Objective: To examine the effectiveness of four doses of psychostimulant medication, combining extended-release methylphenidate (ER-MPH) in the morning with immediate-release MPH (IR-MPH) in the afternoon, on cognitive task performance. Method: The sample comprised 24 children (19 boys and 5 girls) who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision (DSM-IV-TR) criteria for an autism spectrum disorder (ASD) on the Autism Diagnostic Interview-R and the Autism Diagnostic Observation Schedule, and had significant symptoms of attention-deficit/hyperactivity disorder (ADHD). This sample consisted of elementary school-age, community-based children (mean chronological age = 8.8 years, SD = 1.7; mean intelligence quotient = 85; SD = 16.8). Effects of placebo and three dose levels of ER-MPH (containing 0.21, 0.35, and 0.48 mg/kg equivalent of IR-MPH) on cognitive task performance were compared using a within-subject, crossover, placebo-controlled design. Each of the four MPH dosing regimens (placebo, low-dose MPH, medium-dose MPH, and high-dose MPH) was administered for 1 week; the dosing order was counterbalanced across children. Results: MPH treatment was associated with significant performance gains on cognitive tasks tapping sustained attention, selective attention, and impulsivity/inhibition. Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied. Conclusion: The results of this study suggest that MPH formulations are associated with significant improvements on cognitive task performance in children with ASD and ADHD.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno del Espectro Autista/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Cognición/efectos de los fármacos , Preparaciones de Acción Retardada/uso terapéutico , Metilfenidato/uso terapéutico , Niño , Estudios Cruzados , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Masculino , Pruebas Neuropsicológicas , Resultado del TratamientoRESUMEN
Anxiety disorders are among the most common psychiatric disorders in children and adolescents. As reviewed in this guideline, both cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitor (SSRI) medication have considerable empirical support as safe and effective short-term treatments for anxiety in children and adolescents. Serotonin norepinephrine reuptake inhibitor (SNRI) medication has some empirical support as an additional treatment option. In the context of a protracted severe shortage of child and adolescent-trained behavioral health specialists, research demonstrating convenient, efficient, cost-effective, and user-friendly delivery mechanisms for safe and effective treatments for child and adolescent anxiety disorders is an urgent priority. The comparative effectiveness of anxiety treatments, delineation of mediators and moderators of effective anxiety treatments, long-term effects of SSRI and SNRI use in children and adolescents, and additional evaluation of the degree of suicide risk associated with SSRIs and SNRIs remain other key research needs.
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Terapia Cognitivo-Conductual , Inhibidores de Captación de Serotonina y Norepinefrina , Adolescente , Trastornos de Ansiedad/tratamiento farmacológico , Niño , Humanos , Serotonina , Inhibidores Selectivos de la Recaptación de SerotoninaRESUMEN
Objective: Study goals were to (1) provide a rationale for developing a composite primary outcome score that includes symptom severity for attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation, plus symptom-induced impairment; (2) demonstrate weighting methods to calculate the composite score using a sample of children diagnosed with ADHD and aggression; and (3) identify the optimal weighting method most sensitive to change, as measured by effect sizes. Methods: We conducted secondary data analyses from the previously conducted Treatment of Severe Childhood Aggression (TOSCA) study. Children aged 6-12 years were recruited through academic medical centers or community referrals. The composite primary outcome comprised the ADHD, oppositional defiant disorder, disruptive mood dysregulation disorder, and peer conflict subscales from the Child and Adolescent Symptom Inventory (CASI), a DSM (Diagnostic and Statistical Manual)-referenced rating scale of symptom severity and symptom-induced impairment. Five weighting methods were tested based on input from senior statisticians. Results: The composite score demonstrated a larger (Cohen's d) effect size than the individual CASI subscales, irrespective of the weighting method (10%-55% larger). Across all weighting methods, effect sizes were similar and substantial: approximately a two-standard deviation symptom reduction (range: -1.97 to -2.04), highest for equal item and equal subscale weighting, was demonstrated, from baseline to week 9, among all TOSCA participants. The composite score showed a medium positive correlation with the Clinical Global Impressions-Severity scores, 0.46-0.47 for all weighting methods. Conclusions: A composite score that included severity and impairment ratings of ADHD and emotional dysregulation demonstrated a more robust pre-post change than individual subscales. This composite may be a more useful indicator of clinically relevant improvement in heterogeneous samples with ADHD than single subscales, avoiding some of the statistical limitations associated with multiple comparisons. Among the five similar weighting methods, the two best appear to be the equal item and equal subscale weighting methods.
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Síntomas Afectivos/psicología , Agresión/psicología , Trastorno por Déficit de Atención con Hiperactividad/fisiopatología , Déficit de la Atención y Trastornos de Conducta Disruptiva/fisiopatología , Trastorno por Déficit de Atención con Hiperactividad/psicología , Niño , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Humanos , Masculino , Trastornos del Humor/psicología , Escalas de Valoración Psiquiátrica , Índice de Severidad de la EnfermedadRESUMEN
Intellectual disability (intellectual developmental disorder) (ID/IDD) is both a psychiatric disorder and a risk factor for co-occurring psychiatric disorders in children and adolescents. DSM-5 introduced important changes in the conceptualization and diagnosis of ID/IDD, and current research studies clarify assessment and treatment of co-occurring psychiatric disorders in this population. Optimal assessment and treatment of psychiatric illness in children and adolescents with ID/IDD includes modifications in diagnostic and treatment techniques, appreciation of variations in the clinical presentation of psychiatric disorders, an understanding of the spectrum of etiologies of behavioral disturbance, and knowledge of psychosocial and medical interventions.
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Discapacidad Intelectual , Trastornos Mentales , Adolescente , Niño , Comorbilidad , Discapacidades del Desarrollo , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Humanos , Discapacidad Intelectual/diagnóstico , Discapacidad Intelectual/epidemiología , Discapacidad Intelectual/terapia , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Trastornos Mentales/terapia , Factores de RiesgoRESUMEN
(Reprinted with permission from Am J Psychiatry 2018; 175:86-90).
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OBJECTIVE: The Treatment of Severe Childhood Aggression (TOSCA) project examined augmentation of stimulant treatment and parent training (PT) with risperidone for severe physical aggression. This article summarizes the clinical implications; reanalyzes the data to examine the utility of 4 criteria for deciding to augment; and presents a treatment algorithm. METHOD: The newly analyzed 4 criteria for augmenting after 3 weeks of stimulant and PT treatment consisted of not meeting a Clinical Global Impressions-Improvement (CGI-I) score of 1 and a normal score (≤15) on the Nisonger Child Behavior Rating Form Disruptive-Total (D-Total); a CGI-I score of 1 or 2 plus 25% improvement in D-Total score; a D-Total score no higher than 15; and a CGI-Severity score of 3 (mild) or better. Effect sizes were calculated. Prior TOSCA publications were reviewed for clinically relevant findings. RESULTS: All 4 criteria resulted in medium or better effect sizes (d = 0.59-0.72) when comparing risperidone with placebo. Providing risperidone to children who did not reach a CGI-I score of 1 plus a D-Total score no higher than 15 resulted in the greatest benefit. In addition, a review of clinically relevant data suggests that stimulant plus PT shows further improvement after 3 weeks even without augmentation. CONCLUSION: For those children who did not attain a CGI-I score of 1 and a D-total score no higher than 15, adding risperidone maximized the number of children benefitting from treatment and the average amount of benefit. Unless clinical circumstances dictate otherwise, practitioners should delay an antipsychotic drug for at least 1 month after the optimal stimulant dose is achieved and PT has commenced. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study); http://clinicaltrials.gov; NCT00796302.
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Agresión , Antipsicóticos/uso terapéutico , Déficit de la Atención y Trastornos de Conducta Disruptiva/terapia , Estimulantes del Sistema Nervioso Central/uso terapéutico , Padres/educación , Risperidona/uso terapéutico , Déficit de la Atención y Trastornos de Conducta Disruptiva/diagnóstico , Déficit de la Atención y Trastornos de Conducta Disruptiva/psicología , Niño , Terapia Combinada , Esquema de Medicación , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Escalas de Valoración Psiquiátrica , Resultado del TratamientoAsunto(s)
Psiquiatría , Telemedicina , Adolescente , Niño , Humanos , Psiquiatría/tendencias , Telemedicina/tendenciasRESUMEN
OBJECTIVE: This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). METHOD: Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. RESULTS: Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. CONCLUSIONS: Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record
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Trastorno por Déficit de Atención con Hiperactividad/terapia , Dislexia/terapia , Lectura , Negro o Afroamericano , Trastorno por Déficit de Atención con Hiperactividad/complicaciones , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Niño , Terapia Combinada , Dislexia/complicaciones , Femenino , Humanos , Conducta Impulsiva , Aprendizaje , Masculino , Padres , Cooperación del Paciente , Resultado del TratamientoRESUMEN
Transitional age youth (TAY), developing from adolescence to adulthood, exhibit the highest level of alcohol and other drug use of any other age group. Risk factors mirror those for the development of problems and disorders in adolescents. Early screening of both college students and noncollege high-risk TAY in the community is critical to early and effective intervention. Brief interventions using motivational techniques are effective for many TAY, particularly for those in early stages of problem use on college campuses. Professionals in contact with TAY should be aware of evidence-based interventions and providers for substance use disorders in the community.
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Trastornos Relacionados con Sustancias , Adolescente , Adulto , Humanos , Trastornos Relacionados con Sustancias/diagnóstico , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/etiología , Trastornos Relacionados con Sustancias/terapia , Adulto JovenRESUMEN
OBJECTIVES: Previous "Treatment of Severe Childhood Aggression" (TOSCA) reports demonstrated that many children with severe physical aggression and attention-deficit/hyperactivity disorder (ADHD) responded well to two randomized treatments (parent training [PT]+stimulant+placebo = Basic vs. PT+stimulant+risperidone = Augmented) for 9 weeks. An important clinical question is whether these favorable outcomes are maintained over longer times. METHODS: Clinical responders to the 9-week trial (n = 103/168), defined as Clinical Global Impressions (CGI)-Improvement of much/very much improved plus substantial reduction in parent ratings of disruptiveness, were followed another 12 weeks (21 weeks total) while remaining on blinded treatment. Outcome measures included Clinical Global Impressions scale, Nisonger Child Behavior Rating Form (NCBRF), other parent/teacher-rated scales, laboratory tests, clinician ratings of abnormal movement, and other adverse events (AEs). RESULTS: Parent ratings of problem behavior showed minimal worsening of behavior from end of the 9-week acute trial (expected from regression to the mean after selecting best responders), but outcomes at Extension endpoint were meaningfully improved compared with acute study baseline. As expected, outcomes for Basic and Augmented treatment did not differ among these children selected for good clinical response. During Extension, more Augmented subjects had elevated prolactin; there were no clinically confirmed cases of tardive dyskinesia. Delayed sleep onset was the most frequent Basic AE. We also conducted a last-observation-carried-forward analysis, which included both nonresponders and responders. We found that, at the end of Extension, Augmented subjects had more improvement than Basic subjects on the NCBRF Positive Social subscale (p = 0.005; d = 0.44), the Antisocial Behavior Scale Reactive Aggression subscale (p = 0.03; d = 0.36), and marginally so on the Disruptive Behavior Total subscale (p = 0.058; d = 0.29, the primary outcome). CONCLUSIONS: The medium-term outcomes were good for the participants in both treatment groups, perhaps because they were selected for good response. When nonresponders were included in ITT analyses, there was some indication that Augmented surpassed Basic treatment.
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Agresión/efectos de los fármacos , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Risperidona/administración & dosificación , Agresión/psicología , Antipsicóticos/administración & dosificación , Antipsicóticos/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Estimulantes del Sistema Nervioso Central/uso terapéutico , Niño , Terapia Combinada , Método Doble Ciego , Femenino , Humanos , Masculino , Padres/educación , Escalas de Valoración Psiquiátrica , Risperidona/uso terapéutico , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Professionals have periodically expressed concern that atypical antipsychotics may cause cognitive blunting in treated patients. In this study, we report data from a double-blind, randomized, controlled study of stimulant plus placebo versus combined stimulant and risperidone to evaluate the effects of the atypical antipsychotic on attention and short-term memory. METHODS: A total of 165 (n = 83 combined treatment; n = 82 stimulant plus placebo) children with attention-deficit/hyperactivity disorder and severe physical aggression, aged 6-12 years, were evaluated with Conners' Continuous Performance Test (CPT-II) and the Wechsler Intelligence Scale for Children-III (WISC) Digit Span subscale at baseline, after 3 weeks of stimulant-only treatment, and after six additional weeks of randomized treatment (stimulant+placebo vs. stimulant+risperidone). RESULTS: At 3 weeks, improvement on CPT-II performance (Commissions and Reaction Time Standard Error; p < 0.001) and on Digit Span memory performance (p < 0.006) was noted for the full sample. At study week 9, no difference in CPT-II or Digit Span performance was observed between the randomized groups (ps = 0.41 to 0.83). CONCLUSIONS: Similar to other studies, we found no deleterious effects on attention and short-term memory associated with short-term use of risperidone. NCT00796302.
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Agresión/efectos de los fármacos , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Risperidona/administración & dosificación , Antipsicóticos/administración & dosificación , Antipsicóticos/efectos adversos , Antipsicóticos/uso terapéutico , Estimulantes del Sistema Nervioso Central/efectos adversos , Estimulantes del Sistema Nervioso Central/uso terapéutico , Niño , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Masculino , Memoria a Corto Plazo/efectos de los fármacos , Risperidona/efectos adversos , Risperidona/uso terapéutico , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: Stimulant medication is an efficacious and first-line approach to treating ADHD in adolescence. However, less is known about the effectiveness of this approach as a treatment in real-world settings. The complicated nature of the secondary school environment and documented adolescent nonadherence with stimulant medication may undermine the exportability of this approach. METHOD: This study investigates stimulant medication effectiveness and adherence in a sample of adolescents with ADHD who were observed in their natural secondary school environment. RESULTS: Results indicated that the effect of stimulant medication on adolescent functioning is smaller in naturalistic settings than in previous analogue studies. Long-acting pemoline produced greater adherence than the short-acting methylphenidate (MPH), but parents and adolescents preferred the short-acting MPH. CONCLUSIONS: Overall, adolescents reported very low satisfaction with stimulant medication. Findings are discussed.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Metilfenidato/administración & dosificación , Fracaso Escolar , Adolescente , Niño , Estudios Cruzados , Preparaciones de Acción Retardada , Esquema de Medicación , Femenino , Humanos , Masculino , Cumplimiento de la Medicación , Satisfacción del Paciente , Resultado del TratamientoRESUMEN
This study explored the nature of interactions between adolescent males with ADHD and their mothers, and the effects of methylphenidate (MPH) on an analogue parent-teen interaction task. Twenty-five adolescent males with ADHD ( M = 13.6 years) and their mothers and 14 non-ADHD adolescent males ( M = 13.4 years) and their mothers completed ratings of perceived dyadic conflict. Behavioral observations of dyads during 10-min conflict-resolution tasks were also collected. The ADHD dyads completed these tasks twice, with adolescents receiving either 0.3 mg/kg MPH or placebo. Videotaped sessions were coded using the Parent-Adolescent Interaction Rating Scale. Following the conflict-resolution task, participants rated their perceived conflict and affect during the interaction. Findings indicated higher conflict in the ADHD dyads, and minimal MPH effects on parent-teen interactions during the analogue task. Results suggest that stimulant medication does not produce meaningful acute effects on parent-teen interactions.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Metilfenidato/administración & dosificación , Relaciones Padres-Hijo , Adolescente , Afecto/efectos de los fármacos , Análisis de Varianza , Niño , Conflicto Psicológico , Relación Dosis-Respuesta a Droga , Padre/psicología , Femenino , Humanos , Masculino , Madres/psicología , Autoinforme , Encuestas y CuestionariosRESUMEN
OBJECTIVE: Although a number of studies demonstrate that children with ADHD do not attribute their behavior to taking medication, it remains unstudied whether adolescents, who have a longer history of taking medication for ADHD, show performance attributions to medication. METHOD: A sample of 46 adolescents completed daily attributions for success or failure as a part of their participation in a summer treatment program with a double-blind, placebo-controlled assessment of methylphenidate. RESULTS: Results demonstrated that adolescents with ADHD did not reliably discern active medication from placebo, rarely attributed their performance to the pill, and showed no differences in attributional style as a function of medication status. CONCLUSION: These data indicate that adolescents with ADHD may possess inaccurate beliefs about the effect of stimulant medication on their behavior.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Metilfenidato/administración & dosificación , Logro , Adolescente , Niño , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Masculino , Percepción SocialRESUMEN
OBJECTIVE: The objective of this study was to evaluate 52-week clinical outcomes of children with co-occurring attention-deficit/hyperactivity disorder (ADHD), disruptive behavior disorder, and serious physical aggression who participated in a prospective, longitudinal study that began with a controlled, 9-week clinical trial comparing the relative efficacy of parent training + stimulant medication + placebo (Basic; n = 84) versus parent training + stimulant + risperidone (Augmented; n = 84). METHOD: Almost two-thirds (n = 108; 64%) of families in the 9-week study participated in week 52 follow-ups (Basic, n = 55; Augmented, n = 53) and were representative of the initial study sample. The assessment battery included caregiver and clinician ratings and laboratory tests. RESULTS: Only 43% of participants in the Augmented group and 36% in the Basic group still adhered to their assigned regimen (not significant [NS]); 23% of those in the Augmented group and 11% in the Basic group were taking no medication (NS). Both randomized groups improved baseline to follow-up, but the 3 primary parent-reported behavioral outcomes showed no significant between-group differences. Exploratory analyses indicated that participants in the Augmented group (65%) were more likely (p = .02) to have a Clinical Global Impressions (CGI) severity score of 1 to 3 (i.e., normal to mildly ill) at follow-up than those in the Basic group (42%). Parents rated 45% of children as impaired often or very often from ADHD, noncompliant, or aggressive behavior. The Augmented group had elevated prolactin levels, and the Basic group had decreased weight over time. Findings were generally similar whether groups were defined by randomized assignment or follow-up treatment status. CONCLUSION: Both treatment strategies were associated with clinical improvement at follow-up, and primary behavioral outcomes did not differ significantly. Many children evidenced lingering mental health concerns, suggesting the need for additional research into more effective interventions. Clinical trial registration information-Treatment of Severe Childhood Aggression (the TOSCA Study); http://clinicaltrials.gov/; NCT00796302.