Clinical Research
Clinical research and its application in communities is a vital component of improving America’s health. CDM participates in several NIH experimental studies and clinical trials whose goal is to provide the infrastructure for the rapid transfer of science-based treatment—one of the main focus points of the NIH Roadmap.
Many CDM projects focus on understanding and preventing the deterioration in glycemic control, treatment adherence, family relationships, and quality of life that often occur in families during the transition to adolescence of children with type 1 diabetes. The following projects are all funded by the National Institute on Child Health and Development (NICHD):
- Family Management of Childhood Diabetes (Type 1): Data Coordinating Center
CDM is one of two firms partnering to serve as the coordinating center for a large, multi-site clinical trial investigating a behavioral intervention targeting improved adherence and glycemic control among adolescents with Type 1 diabetes. This Coordinating Center collects five waves of data, via home visits and telephone interviews for 480 parent-child dyads (960 subjects) and provides data management and analysis. - Diabetes Management Personal Trainer Study
CDM is collecting data for a randomized trial investigating the role of parents and youth in managing children’s Type 1 diabetes, as well as the feasibility and effectiveness of a personal diabetes trainer in promoting adherence to a management regimen among early adolescents. A sample of 90 youth (ages 11 to 16) and their parents (180 subjects) are followed for two years. - Perception of Childhood Diabetes Study
CDM is collecting data from 90 parent-child dyads (180 subjects) for a longitudinal study of factors that predict adherence to a diabetes regimen for children with Type 1 diabetes, with a particular focus on adolescent developmental transitions. - Follow-up to the Developmental Influences on Management of Type 1 Diabetes and the Diabetes Management Studies
The CDM Group is collecting follow-up data from 180 parent-child dyads who participated in two NICHD longitudinal studies assessing developmental influences on management of Type 1 diabetes.
CDM brings its experience in the substance abuse field to two other clinical research projects:
- CDM, as a subcontractor, participates in the Clinical Coordinating Center (CCC) for the National Institute on Drug Abuse (NIDA) Clinical Trials Network’s (CTN). The CTN conducts multi-site clinical trials to determine the effectiveness of drug abuse treatment interventions in diverse community-based treatment setting and diverse patient populations. The CTN will also transfer research results to treatment programs, clinicians, and their patients to improve the quality of drug abuse treatment throughout the nation.
CDM provides education, training, and protocol development and support for common tools used across the CTN, such as the Common Assessment Battery (CAB) that will serve to standardize assessment procedures, facilitate training across protocols, and enable meta-analyses of study results from all CTN protocols. CDM also provides training on Core Modules which are composed of the CAB and a training on Good Clinical Practice (GCP) for conducting ethically responsible clinical trials research.
- X-Pack: Testing the Efficacy of a Smoking Cessation Aid for Young Smokers. This experimental design study tests the acceptability and efficacy of a smoking cessation aid for young smokers. The aid, called the X-Pack, includes cigarette alternatives, a list of reasons for quitting, a quitting commitment, information about smoking and quitting, and motivational advice. Using a CATI system, CDM conducted two telephone interviews (2 months and 6 months post intervention) with 80 undergraduate college students. This study is funded by the NICHD.