Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-24 @ 4:25 PM
Ignite Modification Date: 2025-12-24 @ 4:25 PM
NCT ID: NCT00644566
Brief Summary: Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during residency to deal with the complexities of ADHD management. In addition, the system of care under which pediatricians practice do not afford the time availability that is required to properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a patient to a child mental health specialist, many obstacles, including but not limited to stigma, insurance issues, and long waiting lists, often interfere with the patient actually receiving services for his/her ADHD. This research project seeks to examine an innovative model of care in which a child psychologist is located on the premises of a pediatric office and is available to share the care of patients with the pediatrician in order to address ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this model of care and that patients will ultimately have better outcomes. The beginning of our pilot has shown under-identification to be a barrier to care as well, and thus we propose to implement a quality improvement initiative to screen children for psychosocial issues as well. As we have had trouble with recruitment and unfortunately have had more children randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where all subjects, instead of randomization, are entered into shared care.
Detailed Description: Study Goals: A. To compare patients with ADHD (Attention Deficit Hyperactivity Disorder) treated by a pediatric provider in collaboration with a co-located psychologist/ADHD care manager available for evaluation/assessment and ongoing shared-care consultation to patients with ADHD in a pediatric primary care clinic treated as usual. 1. Patients treated by the pediatricians with the added co-located services will have clinical outcomes that are superior to those that receive usual care 1. Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services 2. A higher proportion of patients treated by the pediatric providers and psychologists than those in usual care receive doses of medication that are consistent with AAP (American Academy of Pediatrics) recommendations 2. Patients whose providers are offered to receive the aid of the co-located psychologists will be more likely to be co-managed by the pediatrician than referred out to the community. 3. Parents will be more satisfied with care in the shared care model than in usual care B. Pediatricians' morale and attitudes to the treatment of ADHD will improve with the addition of a co-located psychologist. C. ADDITIONAL AIMS: 1. To assist a pediatric primary care clinic in implementing a quality improvement initiative to help pediatric providers better identify ADHD by implementing the PSC-17, a general psychosocial checklist. 2. Study the usefulness of using the PSC 17 screen as a clinical tool to identify ADHD in the primary care office by obtaining results and tracking physician disposition planning based on results. D. Operationalize Shared Care by examining what happens in such an arrangement, and see if patient recruitment and provider buy-in improves when shared care is assured.
Study: NCT00644566
Study Brief:
Protocol Section: NCT00644566