Regulatory and ethical principles in research involving children and individuals with developmental disabilities

Children and individuals with developmental disabilities (DD) compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable participation. Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy.     

Children's competence for assent and consent: a review of empirical findings

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identifies several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interest approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence and comparison of children's competence for treatment and research decisions.     

Brain development in autism: early overgrowth followed by premature arrest of growth

Due to the relatively late age of clinical diagnosis of autism, the early brain pathology of children with autism has remained largely unstudied. The increased use of retrospective measures such as head circumference, along with a surge of MRI studies of toddlers with autism, have opened a whole new area of research and discovery. Recent studies have now shown that abnormal brain overgrowth occurs during the first 2 years of life in children with autism. By 2-4 years of age, the most deviant overgrowth is in cerebral, cerebellar, and limbic structures that underlie higher-order cognitive, social, emotional, and language functions. Excessive growth is followed by abnormally slow or arrested growth. Deviant brain growth in autism occurs at the very time when the formation of cerebral circuitry is at its most exuberant and vulnerable stage, and it may signal disruption of this process of circuit formation. The resulting aberrant connectivity and dysfunction may lead to the development of autistic behaviors. To discover the causes, neural substrates, early-warning signs and effective treatments of autism, future research should focus on elucidating the neurobiological defects that underlie brain growth abnormalities in autism that appear during these critical first years of life.     

Comorbidity in compulsive hoarding: a case report

A 56-year-old male presented with compulsive hoarding along with attention-deficit/hyperactivity disorder and schizotypal personality disorder. Hoarding has been described as difficult to treat both pharmacologically and behaviorally, and this patient's comorbid conditions also contributed to his overall impairment. The patient's treatment regimen of fluvoxamine, amphetamine salts, and risperidone, along with behavioral therapy, has helped with hoarding behaviors, motivation, procrastination, and increased socialization. Hoarding may be a unique subtype of obsessive-compulsive disorder with poorer prognosis and distinct neuroanatomic dysfunction. Augmentation with stimulants may provide benefits in aspects of hoarding such as procrastination, especially in patients with comorbid attention-deficit hyperactivity disorder.     

Impact of recent findings on study design of future autism clinical trials

There are specific challenges to studying the design of pharmacologic trials in child/adolescent and adult autism, such as subject stratification and parallel versus crossover designs. This article describes how optimal study design is influenced by subject selection and outcome measures chosen. Lessons learned in study design from the Research Units on Pediatric Psychopharmacology Autism Network trial with risperidone, Seaver Center trials with fluoxetine and valproate, Dartmouth trials with amantadine, and National Institutes of Health secretin trials are highlighted. The Internet System for Assessing Autistic Children system for managing multicenter clinical trials in autism and statistical issues in autism research are also described.     

The use of a distractor-assigned response slows later responding in a location negative priming task

Responding to a target's location takes longer when that location has recently contained a distractor event (ignored-repetition [IR] trial) relative to when it has been unoccupied (control trial). This is known as the location negative priming (NP) effect. We aimed to determine whether the elevated reaction time observed for IR trials was due to the reuse of a distractor location (location locus) and/or to the need to execute a (just inhibited) distractor response (response locus). We isolated these loci latency effects by using many-to-one and one-to-many location-response assignments. Our results showed that reusing a distractor location hastened target processing at that position (facilitative location locus), whereas the production of a distractor response was associated with a time cost (interfering response locus). Accordingly, part of the latency elevation seen with IR trials results from the need on these occasions to execute ajust inhibited (distractor) response, and, hence, the location NP effect has a response locus.     

Competitive martial arts and aggressiveness: a 2-yr. longitudinal study among young boys

This study is a follow-up study of Reynes and Lorant's studies assessing the effect of one year of judo and karate training on aggressiveness scores among young boys. The data reported here were obtained after a second year of practice, 14 judoka, 9 karateka, and 20 control participants who filled out the Buss-Perry Aggression Questionnaire three times, 1 year apart. At the first assessment, all participants, born the same year, were 8 yr. old and at the third they were 10 yr. old. Analysis indicated that after two years of practice, karate training seemed to have neither positive nor negative effects on aggressiveness scores, while judo training seemed to have a negative effect on anger scores. However, the results suggested the importance of kata or meditation in training sessions on self-control acquisition for such young boys.     

Equivalents of Mingle and Positive Paradox

Relevant logic is a proper subset of classical logic. It does not include among its theorems any ofpositive paradox A (B A)mingle A (A A)linear order (A B) (B A)unrelated extremes (A ) (B B¯)This article shows that those four formulas have different effects when added to relevant logic, and then lists many formulas that have the same effect as positive paradox or mingle.     

Transition planning and recidivism among mentally ill juvenile offenders

OBJECTIVES: To determine the extent to which transition planning and community service would predict lower levels of recidivism among mentally ill juvenile offenders. DESIGN: Review of legal, medical and social service records including examination of 3-month period following community release. PARTICIPANTS: Juvenile offenders incarcerated for 6 months or more (N = 44) transitioning to community. MEASURES: Child and Adolescent Functional Assessment Scale (CAFAS), sum of different documented pre- and post-release discharge planning contacts, documented community service contacts. OUTCOMES: Re-offense during the first year post-release. RESULTS: Documented community service contacts in the 3 months following discharge were rare for mental health (20.5%), substance abuse (38.6%), financial assistance (29.5%), and school placement (34.1%). The average number of different pre-release and post-release discharge planning contacts was also low, M(SD)=1.86(1.68) and M(SD)= 2.34(1.71) respectively. Post-release discharge planning and the receipt of financial assistance and mental health services were all associated with lower levels of reoffending. CONCLUSIONS: Community transition planning, including the coordination and provision of community services, is an essential component of community reintegration for juvenile offenders and is associated with lower rates of recidivism during the first year post-discharge.