A pediatric, practice-based, randomized trial of drinking and smoking prevention and bicycle helmet, gun, and seatbelt safety promotion

Objective. To prevent early adolescent health risk behaviors and to maintain or improve safety behaviors, we compared the effects of 2 interventions, delivered through pediatric primary care practices. The interventions, based on an office systems' approach, sought to prevent early drinking and smoking or to influence bicycle helmet use, gun storage, and seatbelt safety for children who were followed from fifth/sixth grades through eighth/ninth grades. Design. Settings and Participants. Twelve pediatric practices in New England were paired according to practice size and assigned randomly within pairs to deliver the multicomponent interventions, which built on pediatric primary care clinicians performing as counselors and role models during health supervision visits and other office encounters. Intervention. One intervention arm focused on alcohol and tobacco use. The other intervention arm focused on gun safety, bicycle helmet, and seatbelt use. Office systems provided infrastructure that supported the clinician's role. Clinician messages encouraged family communication and rule setting about the issues of the middle school years. The intervention was initiated during a health supervision visit and continued for 36 months. Both child and parent received quarterly newsletters to reinforce the clinician messages. Outcome Measures. The primary outcomes were ever drinking alcohol, ever smoking, ever using smokeless tobacco, using a bicycle helmet in the previous year, using a seatbelt in the previous 30 days, and guns in the child's home in locked storage. Results. The pediatric practices recruited 85% (N = 3525) of the practices' fifth/sixth grade children and their responding parents. We obtained 36 months' follow-up data on 2183 child-parent pairs. Chart audit verified that the intervention was implemented. Additional data from interviews and surveys showed that parents, children, and pediatric clinicians found the intervention useful. Despite this, comparisons between the 2 study arms show no significant intervention effects in the prevention of alcohol and tobacco use or gun storage or seatbelt safety. There was a negative effect in the alcohol arm. Only bicycle helmet use showed a positive outcome. Conclusion. With rigorous evaluation, 2 office interventions failed to produce desired outcomes. Coordinated multiple settings for prevention interventions are probably necessary.