Research Design And Methods
This trial has been previously described in detail, including the precise methodology (13-16).
Type 1 diabetic adolescents and their parents were recruited in St. Louis, MO, and Jacksonville, FL. Recruitment included an initial confirmation of eligibility based on demographic factors, followed by a screening process to ensure that enrolled families had at least moderate levels of parent-adolescent conflict. Initially, 380 families were informed of the study. Adolescents eligible for the study met the following criteria: aged 12-17 years; having type 1 diabetes $ 1 year; no other major chronic diseases; no mental retardation; not incarcerated, in foster care, or in residential psychiatric treatment; and no diagnoses of psychosis, major depression, or substance abuse disorder in adolescents or parents during the previous 6 months. Each parent or stepparent residing with the patient was required to participate in the study, and other adult caregivers were allowed to participate.
Then, interested families who met the above criteria (n 5 178) gave their written informed consent and completed two screening questionnaires: the Conflict Behavior Questionnaire (CBQ) (17) and the Diabetes Responsibility and Conflict (DRC) scale (18). Specified cutoff scores were expected to exclude ; 60% of families (CBQ $ 5 and DRC $ 24). Only families in which at least one member obtained a score exceeding one of these cutoffs were eligible. Of 132 families scoring above this criterion, 119 (90%) enrolled in the study. Participants included 119 adolescents, 117 female caregivers, and 82 male caregivers.
Various questionnaires and biochemical data were obtained at baseline evaluation and at follow-up evaluations scheduled at posttreatment (3 months) and again at 6 and 12 months after treatment ended. The questionnaires sought the respondents' ratings of specific behavioral variables over the preceding 3-month period to ensure temporal congruity among the various measures. A detailed manual ensured the equivalence of the procedures at the two sites.
Demographic Factors. Parents reported the basic demographic information and the data needed for estimating socioeconomic status with the Hollingshead Four Factor Index of Social Status (A.B. Hollingshead, unpublished data).
General Parent-Adolescent Relationships. The Parent-Adolescent Relationship Questionnaire (PARQ) was developed by Robin et al. (19) to assess the primary constructs in the behavioral-family systems model of parent-adolescent conflict. It yields three-factor-analytically derived scales: Overt Conflict/Skill Deficits, Extreme Beliefs, and Family Structure. There are separate forms for adolescents (314 true/false items) and parents (280 items), and normative data were available from 314 adolescents and 427 parents. During each administration of this instrument, participants were instructed to rate family behavior over the preceding 3 months. Internal consistency (Cronbach's a coefficient), calculated on data obtained from this sample, ranged from 0.73 to 0.89 for the three scales and did not differ among mothers, fathers, and adolescents. Type 1 Diabetes-Specific Psychological Adjustment. The Teen Adjustment to Diabetes Scale (TADS) is a 21-item Likert-type scale with parallel parent and adolescent forms that measures adolescent behavioral, affective, and attitudinal adjustment to diabetes over a 3-month period (9). Higher scores indicate more favorable adjustment. Internal consistency, calculated from data obtained from a total of 604 participants in the present and previous studies, was 0.88 for adolescents, 0.91 for mothers, and 0.84 for fathers.
The DRC assesses parent-child division of diabetes responsibilities and family conflict over 15 diabetes tasks during the preceding 3 months (18). Only the conflict items were used in this study because family division of diabetes responsibilities was not targeted by BFST in this study. Internal consistency based on the present sample was 0.92 for adolescents, 0.86 for mothers, and 0.89 for fathers.
Type 1 Diabetes Treatment Adherence. The 14-item Self-Care Inventory (SCI), which was validated by Greco et al. (20), was used to measure diabetes treatment adherence during the preceding 3 months. The SCI correlates significantly with corresponding parts of Johnson's (21) recall interview method and with GHb level. Higher scores indicate better treatment adherence. Total scores on the parent and adolescent forms of the SCI were used for this report. Internal consistency based on this sample was 0.76 for adolescents, 0.81 for mothers, and 0.82 for fathers.
Health Status. Using affinity chromatography methods, laboratory staff collected a 3-cm 3 venous blood sample from each patient for total GHb assays to index recent glycemic control. The normal range for the assay was ; 6- 8%, and within the range typical of adolescents with diabetes, it yields results that are 2-3% higher than the HbA1c assay, which has been widely adopted since this study was initiated.
At the end of the baseline evaluation, a research assistant randomly assigned each family to one of the three conditions described below. Randomization was stratified by the adolescent's sex and by the treatment center, so that each center enrolled a similar number of boys and girls into the three groups.
Current Therapy. Patients in the current therapy (CT) group (as well as those in the other groups) received standard diabetes therapy from pediatric endocrinologists, including an examination by a physician and a GHb assay at least quarterly; two or more daily injections of mixed inter-mediate-and short-acting insulins; self-monitoring of blood glucose and recording of test results; diabetes self-management training; a prescribed diet; physical exercise; and an annual evaluation for diabetic complications.
Education and Support. In the first 3 months of the study, families in the education and support (ES) group attended 10 group meetings that provided diabetes education and social support. This was formulated as a common mental health service for families of this population and as a "best alternative therapy" comparison. A social worker at one center and a health educator at another center served as group facilitators. Panels of two to five families began and completed 10 sessions together; the parents and the adolescent with diabetes attended the sessions. The same educational materials and session outlines were used at both sites, and the two facilitators conferred weekly by telephone to ensure cross-site consistency of the intervention. Family communication and conflict resolution skills were specifically excluded from session content, because these are the primary targets of BFST. Each session included a 45-min educational presentation by a diabetes professional, followed by a 45-min inter-action among the families about a topic led by the facilitator.
BFST. Adolescents and caregivers in this group received 10 sessions of BFST (12). Sessions were conducted by one woman and one man (P.G., M.A.H.) who received extensive training in this approach. A detailed therapy manual supplemented the guidelines presented by Robin and Foster (12) and included session outlines, handouts, and homework assignments that were used at both sites. BFST consisted of four therapy components that were used in accordance with each family's treatment needs as identified by the project psychologists and was based on study data and family interaction during sessions.
Problem-Solving Training. Problem-solving training provided families with a behavioral contracting approach to conflict resolution with training in problem definition; generation of alternative solutions; group decision-making, planning, implementation, and monitoring of the selected solution; and renegotiation or refinement of the ineffective solutions.
Communication skills training. Communication skills training included instructions, feedback, modeling, and rehearsal targeting common parent-adolescent communication problems.
Cognitive restructuring. Cognitive restructuring methods were used to identify and change family members' irrational beliefs, attitudes, and attributions that may have impeded effective parent-adolescent communication and conflict resolution.
Functional and Structural Family Therapy. Functional and structural family therapy interventions targeted anomalous family systemic characteristics (e.g., weak parental coalitions or cross-generational coalitions) that may have impeded effective problem solving and communication.
Families received an individualized treatment plan guided by baseline assessments and ongoing observation of family interactions. Sessions consisted of family problem-solving discussions focusing on diabetes-related or general conflicts as appropriate for each family. The psychologists used standard behavior therapy techniques of instruction, feedback, modeling, and rehearsal. Behavioral homework (i.e., encouraging families to practice targeted skills at home) was assigned at each session and reviewed at the next session.
To maximize completion of data collection, families were paid $100 ($50 each for the parents and adolescent) on completion of each evaluation. ES and BFST families could earn another $100 if they completed all 10 scheduled intervention sessions. The posttreatment evaluations were completed by 115 families (96%), the 6-month follow-up by 113 families (95%), and the 12-month follow-up by 108 families (91%). All scheduled intervention sessions were completed by 87% of BFST families and 91% of ES families.
Psychological services outside of the study were received by 5 CT families (22 sessions total), 3 ES families (21 sessions total), and no BFST families. There were no psychiatric hospitalizations.
To reduce the number of statistical comparisons and enhance the reliability of outcome measures, family composite scores were calculated by summing and averaging the scores of individual family members. In each case, there were significant positive correlations (range 0.45-0.83) between family members' scores. This procedure reduced the number of statistical comparisons and reduced variability in some measures.
Diabetes Care. 2001;24(3) © 2001 American Diabetes Association, Inc.
Cite this: Behavior Therapy for Families of Adolescents With Diabetes: Maintenance of Treatment Effects - Medscape - Mar 01, 2001.