OBJECTIVE:This study reports 6- and 12-month follow-up for the families of adolescents with diabetes who participated in a trial of Behavioral-Family Systems Therapy (BFST).RESEARCH DESIGN AND METHODS:A total of 119 families of adolescents with type 1 diabetes were randomized to 3 months of treatment with either BFST, an education and support (ES) group, or current therapy (CT). Family relationships, adjustment to diabetes, treatment adherence, and diabetic control were assessed at baseline, after 3 months of treatment, and 6 and 12 months later. This report focuses on the latter two evaluations.RESULTS:Compared with CT and ES, BFST yielded lasting improvements in parent-adolescent relationships and diabetes-specific conflict. Delayed effects on treatment adherence emerged at 6- and 12-month follow-ups. There were no immediate or delayed effects on adolescents' adjustment to diabetes or diabetic control.CONCLUSIONS:BFST yielded lasting improvement in parent-adolescent relationships and delayed improvement in treatment adherence, but it had no effect on adjustment to diabetes or diabetic control. A variety of adaptations to BFST could enhance its impact on diabetes outcomes.

OBJECTIVE:To describe the short-term results of a controlled trial of Behavioral Family Systems Therapy (BFST) for families of adolescents with diabetes.METHODS:We randomized 119 families of adolescents with diabetes to 3 months' treatment with either BFST, an education and support Group (ES), or current therapy (CT). Family relationships, psychological adjustment to diabetes, treatment adherence and diabetic control were assessed at baseline, after 3 months of treatment (reported here), and 6 and 12 months later.RESULTS:Compared with CT and ES, BFST yielded more improvement in parent-adolescent relations and reduced diabetes-specific conflict. Effects on psychological adjustment to diabetes and diabetic control were less robust and depended on the adolescent's age and gender. There were no effects on treatment adherence.CONCLUSIONS:BFST yielded some improvement in parent-adolescent relationships; its effects on diabetes outcomes depended on the adolescent's age and gender. Factors mediating the effectiveness of BFST must be clarified.

Compared the social validity of behavior therapy vs. support group interventions for reduction of parent-adolescent conflict among families of adolescents with diabetes. Families were randomized to 10 sessions of an Education and Support group (ES) or 10 sessions of Behavioral Family Systems Therapy (BFST). We compared participants' social validity ratings of BFST and ES using the Treatment Evaluation Questionnaire (TEQ). Mean TEQ scores were significantly more positive for BFST than ES and, for 13 of 20 items, BFST was rated significantly more positively by parents and/or adolescents. Adolescents rated ES less positively than did parents. Fathers' responses reflected fewer differences between ES and BFST. Results extend previous research on BFST and confirm its superiority over ES for targeting family conflict.

The recently completed Diabetes Control and Complications Trial (DCCT) has elicited renewed interest in behavior change strategies, because intensive therapy of 1DDM in the DCCT was a comprehensive behavioral change program with unequivocal health benefits (1,2). Intensive therapy lowered blood glucose levels and slowed the appearance and progression of microvascular and neuropathic complications because participants changed many behaviors, including testing blood glucose and administering insulin more frequently, quantifying and regulating dietary intake, and modifying diet, insulin, and physical activity to balance their effects on blood glucose levels. It is natural to ask what can be learned from the DCCT about changing behavior that is pertinent to diabetes management in clinical practice. The DCCT compared two treatment programs that differed in many ways. Among the differences between the two treatments was the more frequent use of behavioral change strategies in the intensive therapy group. Use of specific behavior change strategies depended on the needs of individual patients. In addition, while the framework of intensive therapy was dictated by the study protocol, the detailed application of behavioral change strategies is presumed to have varied with the skills and preferences of each Clinical Center staff, as was also true of other elements of treatment such as insulin management and the choice of pump or multiple injection therapy. Consequently, there were uncontrolled differences across clinics and individuals in the use of behavioral interventions. Therefore, the DCCT Study Group has not attempted to draw systematic conclusions about the effectiveness of specific behavioral change strategies or other elements of the intensive therapy program. Nevertheless, it is possible to offer opinions on the behavioral strategies that seemed most helpful. To generate a broad synthesis of practical lessons from the DCCT, the first author recruited collaborators from several DCCT Clinics and disciplines, including nursing, nutrition, clinical psychology, psychiatry, and social work. The practical lessons we offer here were not discovered or used for the first time in the DCCT, but are well grounded in a large body of literature, examples of which we cite. A short list of additional reading is also included. The point emphasized here is that the DCCT has demonstrated that these strategies are truly effective in achieving longterm behavioral changes and health benefits in subjects with IDDM. Before discussing specific behavioral change strategies, we wish to articulate a general principle suggested by the DCCT: ordinary people can adopt and maintain substantial behavioral changes. Because of the extraordinary adherence of the DCCT volunteers to the protocol, it has been implied that they were so well

OBJECTIVE - To describe the methods used to implement intensive and conventional therapies in the Diabetes Control and Complications Trial (DCCT) and the metabolic results that occurred with the different treatment regimens.RESEARCH DESIGN AND METHODS - The DCCT was a controlled clinical trial that demonstrated the beneficial effect of intensive therapy on the long-term complications of insulin-dependent diabetes mellitus (IDDM). A total of 1,441 volunteers with IDDM, aged 13-39, from 29 centers in the U.S. and Canada, were randomly assigned to conventional or intensive diabetes therapy. Intensive therapy, which used multiple daily injections (MDI) of insulin (greater than or equal to 3 injections/day) or continuous subcutaneous insulin infusion (CSII), was implemented by a team that included diabetes nurses, dietitians, behavioral experts, and diabetologists. Volunteers in the intensive treatment group could use MDI or CSII, based on patient and clinic preference, and could switch between therapies over the course of the study. The volunteers were followed for a mean of 6.5 years (range 3-9 years).RESULTS - A detailed analysis of implementation of the two treatments indicates that intensive and conventional treatment subjects adhered to their respective insulin injection regimens >97% of the time. Adherence to other elements of intensive treatment was similarly high and resulted in median HbA(1c) values between 6.7 and 7.2, compared with 8.7-9.2 with conventional therapy, over the course of the study. Severe hypoglycemia occurred three times more often in intensively treated subjects. Although subjects on intensive treatment were not randomly assigned to MDI or CSII, we compared those subjects who used either of these methods for greater than or equal to 90% of the study time. CSII-treated patients maintained a mean HbA(1c) of 6.8 vs. 7.0 in MDI-treated subjects during the trial (P < 0.05). The frequency of hypoglycemia with coma and seizure and diabetic ketoacidosis was modestly higher with CSII than with MDI.CONCLUSIONS - Intensive therapy was implemented successfully in the DCCT. The detailed description herein will serve to facilitate translation of the DCCT results to the clinical setting.

Objective: To determine the magnitude of the decrease in the risk of retinopathy progression observed with intensive treatment and its relationship to baseline retinopathy severity and duration of follow-up.Design: Randomized clinical trial, with 3 to 9 years of follow-up.Setting and Patients: Between 1983 and 1989, 29 centers enrolled 1441 patients with insulin-dependent diabetes mellitus aged 13 to 39 years, including 726 patients with no retinopathy and a duration of diabetes of 1 to 5 years (primary prevention cohort) and 715 patients with very mild to moderate nonproliferative diabetic retinopathy and a duration of diabetes of 1 to 15 years (secondary intervention cohort). Ninety-five percent of all scheduled examinations were completed.Interventions: Intensive treatment consisted of the administration of insulin at least three times a day by injection or pump, with doses adjusted based on self-blood glucose monitoring and with the goal of normoglycemia. Conventional treatment consisted of one or two daily insulin injections.Outcome Measures: Change between baseline and follow-up visits on the Early Treatment Diabetic Retinopathy Study retinopathy severity scale, assessed with masked gradings of stereoscopic color fundus photographs obtained every 6 months.Results: Cumulative 8.5-year rates of retinopathy progression by three or more steps at two consecutive visits were 54.1% with conventional treatment and 11.5% with intensive treatment in the primary prevention cohort and 49.2% and 17.1% in the secondary intervention cohort. At the 6- and 12-month visits, a small adverse effect of intensive treatment was noted (''early worsening''), followed by a beneficial effect that increased in magnitude with time. Beyond 3.5 years of follow-up, the risk of progression was five or more times lower with intensive treatment than With conventional treatment. Once progression occurred, subsequent recovery was at lease two times more likely with intensive treatment than with conventional treatment. Treatment effects were similar in all baseline retinopathy severity subgroups.Conclusion: The results of the Diabetes Control and Complications Trial strongly support the recommendation that most patients with insulin-dependent diabetes mellitus use intensive treatment, aiming for levels of glycemia as close to the nondiabetic range as is safely possible.

This article examines the relationships among family stress, family capabilities, and the health status of 53 children diagnosed with insulin-dependent diabetes mellitus. Assessments were done at an outpatient diabetes clinic of family coping, resources, and stress; disease-related knowledge; metabolic control (HbA1); and endogenous insulin (C peptide). Results indicated that higher levels of family stress and lower levels of family resources as reported by fathers were significantly associated with poor metabolic control. Multiple regression analyses revealed that levels of family stress and resources were more strongly related to metabolic control than were disease variables such as C peptide levels. Moreover, family stress was directly associated with metabolic control, and family resources showed indirect linkages. Findings suggest that family stress and resources are potential areas for social work intervention in children recently diagnosed with diabetes.