Nemours Children s Clinic, and 2Washington University, St. Louis School of Medicine
Background Behavioral family systems therapy (BFST) for adolescents with diabetes has
improved family relationships and communication, but effects on adherence and metabolic control were weak. We evaluated a revised intervention, BFST for diabetes (BFST-D). Methods
One hundred and four families were randomized to standard care (SC) or to 12 sessions of either
an educational support group (ES) or a BFST-D over 6 months. Family relationships, adherence,
glycosylated hemoglobin (HbA1c), and health care utilization were measured at baseline and after
treatment. Results BFST-D significantly improved family conflict and adherence compared
to SC and ES, especially among those with baseline HbA1c 9.0%. BFST-D and ES significantly
improved HbA1c compared to SC among those with baseline HbA1c 9.0%. Conclusions
The revised intervention (BFST-D) improved family conflict and treatment adherence significantly, while both ES and BFST-D reduced HbA1c significantly, particularly among adolescents
with poor metabolic control. Clinical translation of BFST-D requires further study.
Key words
communication, and systemic barriers to problem solving (Robin & Foster, 1989). The effectiveness of BFST
has been verified in several studies (Barkley, Guevremont,
Anastopoulos, & Fletcher, 1992; Foster, Prinz, & OLeary,
1983; Robin, Seigel, Kopeke, Moye, & Tice, 1994). In a
previous randomized controlled trial with families of
adolescents with type 1 diabetes (Wysocki et al., 2000),
10 sessions of BFST over a 3-month interval yielded lasting improvements in parentadolescent relationships
and family communication skills as measured by parent
and adolescent report (Wysocki et al., 2000) or by direct
observation of structured family interactions (Wysocki
et al., 1999). These benefits persisted for 12 months
(Wysocki et al., 2001), and BFST was rated as more
acceptable, applicable, and effective than was an educational support group (ES) (Wysocki et al., 1997). But,
BFST did not impact glycemic control or treatment
All correspondence concerning this article should be addressed to Tim Wysocki, PhD, Center for Pediatric Psychology
Research, Nemours Childrens Clinic, 807 Childrens Way, Jacksonville, Florida 32207. E-mail: twysocki@nemours.org.
Journal of Pediatric Psychology 31(9) pp. 928938, 2006
doi:10.1093/jpepsy/jsj098
Advance Access publication January 9, 2006
Journal of Pediatric Psychology vol. 31 no. 9 The Author 2006. Published by Oxford University Press on behalf of the Society of Pediatric Psychology.
All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org
adherence (Wysocki et al., 2000, 2001). This second randomized trial, as reported here, sought to determine
whether a revised intervention with diabetes-specific
behavioral components, BFST for Diabetes (BFST-D),
would have more robust effects on treatment adherence
and diabetic control. Concurrently, various researchers
reported the effectiveness of other intervention strategies
with this clinical population (see Hampson et al., 2001
for a review). Drawing on this recent work, the BFST
intervention was adapted by incorporating diabetes-specific
elements of many of these approaches into BFST-D.
The following hypotheses were evaluated for this
article:
Hypothesis 1: Relative to SC and ES, families in
BFST-D will exhibit significantly more improvement in parentadolescent relationships (PARQ
scores) and diabetes-related conflict (DRC scores)
after 6 months of treatment.
Hypothesis 2: Relative to SC and ES, adolescents in
BFST-D will show significantly more improvement
in medical adherence (DSMP scores) after 6 months
of treatment.
Hypothesis 3: Relative to SC and ES, adolescents in
BFST-D will achieve significantly greater reduction
in HbA1c, indicating better metabolic control, after
6 months of treatment.
Hypothesis 4: Relative to SC and ES, adolescents in
BFST-D will have significantly fewer hospitalizations
and emergency room visits during the 6 months of
study intervention.
Methods
Participants and Settings
Recruitment occurred at two pediatric centers in the
Southeastern and Midwestern United States. Recruitment objectives were to enroll a clinically appropriate
sample of adolescents and their families who were experiencing significant problems with diabetes management. Parents and adolescents signed institutionally
approved informed consent and assent forms, respectively, before any research procedures occurred.
Inclusion criteria were: adolescent age between 11
and 16 years inclusive; type 1 diabetes or insulin-treated
type 2 diabetes for at least 2 years; HbA1c 8.0% (which
has been defined as the threshold for clinical action by
the American Diabetes Association, 2005); agreement to
participate from all adult caregivers living with the adolescent; willingness to accept randomization; intent to
continue diabetes care at the enrolling center for
Determined Ineligible
(n=48)
Randomized
(n=104)
SC
(n=32)
ES
(n=36)
Lost to Follow-up
(n=3)
Lost to Follow-up
(n=1)
Complete Data
(n=29)
Complete Data
(n=35)
BFST-D
(n=36)
Lost to Follow-up
(n=8)
Complete Data
(n=28)
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930
Wysocki et al.
SC
ES
BFST-D
14.2 1.9
14.4 1.9
13.9 1.9
5.9 4.0
5.5 3.2
5.1 3.0
HbA1c (%)
9.5 1.5
9.7 1.6
9.6 1.6
40.3 14.2
40.1 11.6
40.4 13.7
16 (50%)
20 (56%)
21 (58%)
Female
16 (50%)
16 (44%)
15 (42%)
Caucasian
17 (53%)
27 (75%)
22 (61%)
African-American
11 (34%)
9 (25%)
12 (33%)
Race/ethnicity
Hispanic
2 (6%)
1 (3%)
Other
2 (6%)
1 (3%)
Family composition
Intact
Blended
Single parent
Other
13 (41%)
15 (42%)
4 (13%)
5 (14%)
16 (43%)
7 (19%)
11 (34%)
12 (33%)
11 (32%)
4 (13%)
4 (11%)
2 (5%)
25 (78%)
27 (75%)
27 (75%)
7 (22%)
9 (25%)
9 (25%)
Insulin modality
Injections
Insulin pump
For continuous variables, the values are mean 1 SD. For categorical variables,
the values are the number and percent of participants in each category.
Experimental Design
A three-group, randomized treatment design was used
with four repeated measures at baseline, after treatment
(6-months), and follow-up at 6 and 12 months after
treatment. This article reports only the baseline and
immediate posttreatment results as the sample continues
in follow-up at this time. Following the baseline evaluation, as described below, families were randomized
(stratified by baseline HbA1c) to standard care (SC), ES,
or BFST-D for the next 6 months. The three experimental conditions are described below.
Standard Care (SC)
Diabetes care for all study participants reflected the prevailing clinical practices at each site during the study. Treating
physicians selected an HbA1c target for each adolescent
that was as close to the upper limit of normal (6.5%) as was
considered safe and feasible. HbA1c was measured before
each clinic visit and reviewed during the visit. Daily insulin
replacement was achieved via multiple subcutaneous injections or insulin pump. Adolescents were asked to perform
self-monitoring of blood glucose (SMBG) three or more
times daily. Quarterly clinic visits were scheduled with a
pediatric endocrinologist or other qualified clinician. A
certified diabetes educator (CDE) provided basic and
advanced diabetes education to families. Adolescents were
offered a meal plan based on carbohydrate counting or an
exchange system and encouraged to follow a personalized
Participation Incentives
Participants were paid to promote adherence to the study
tasks. Each family was paid $100 ($50 for parents and
$50 for youth) for completing the scheduled evaluations.
Each ES and BFST-D family received another $100, distributed in the same way, if they attended all 12 scheduled intervention sessions for their respective groups.
These incentives resulted in >90% retention of the study
sample in our previous work (Wysocki et al., 2001).
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Wysocki et al.
Results
Sampling and Randomization
Table I summarizes baseline demographic characteristics of the three groups. There were no statistically significant between-group differences at baseline on patient
age, duration of diabetes, socioeconomic status, or of the
distributions of gender, race/ethnicity, family composition, or parental marital status. The sample included the
following proportion of families in each Hollingshead
socioeconomic stratum: lower: 4.8%; lower middle:
21.2%; middle: 38.5%; upper middle: 24.0%; and upper:
11.5%. The groups also did not differ significantly at
baseline with respect to HbA1c or scores on the PARQ,
DRC, or DSMP. Members of racial and ethnic minorities
comprised 37% of the sample. Among the 104 families
Extreme
beliefs
Family
structure
SC
50.7 (5.9)
50.4 (7.3)
49.7 (6.6)
ES
50.8 (6.4)
49.7 (8.1)
49.2 (7.6)
BFST-D
50.8 (7.3)
51.7 (7.0)
51.3 (7.3)
SC
49.9 (6.3)
48.7 (8.8)
48.2 (7.6)
ES
49.6 (6.1)
48.8 (7.5)
48.0 (8.3)
BFST-D
50.0 (6.7)
48.7 (8.4)
51.9 (7.2)
Treatment groups
>9.0%
7
5
3
SC
ES
BFST-D
1
-1
-3
-5
-7
(Lower scores = less family conflict)
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Wysocki et al.
>9.0%
5
4
3
2
1
0
-1
SC
ES
BFST-D
-2
-3
-4
-5
(Higher scores = better adherence)
Discussion
This article reports the immediate posttreatment results
of a randomized controlled trial comparing SC for diabetes
934
<9.0%
>9.0%
0.5
0
SC
ES
BFST-D
-0.5
-1
-1.5
-2
(Lower scores = improved metabolic control)
period. This difference, as illustrated in Fig. 2, was attributable primarily to fairly substantial treatment effects for
youths with the poorest baseline HbA1c levels and is
best described as prevention of worsening of diabetesrelated family conflict that occurred in the SC and ES
groups. The absence of corresponding effects on more
general parentadolescent relationships (i.e., PARQ
scores) may reflect the emphasis within BFST-D on targeting diabetes-specific problems rather than focusing
on more general aspects of family relationships. Also, in
distinction to the present trial, the enrollment criteria
for the previous BFST trial required that families
exceeded specific cut-off scores indicating moderate or
greater family conflict. Consequently, PARQ scores for
the present sample were comparatively lower, possibly
diminishing the capacity to detect treatment effects on
this measure. Alternatively, study participation may
have sensitized some participants to problems in family
communication or conflict resolution that were not
readily apparent to them at baseline. Each of these interpretations is quite speculative at this time.
Hypothesis 2 consisted of the prediction that BFST-D
would yield more improvement in diabetes selfmanagement behaviors (DSMP scores) compared with
either SC or ES. The results clearly confirmed Hypothesis 2
by revealing a statistically significant main effect for
treatment group favoring BFST over SC and ES and by a
significant group time interaction effect, as shown in
Fig. 3. DSMP scores were significantly more favorable
for the BFST-D group than the SC or ES groups within
both baseline HbA1c ranges.
Hypothesis 3 addressed the comparative effects of SC,
ES and BFST-D on change in HbA1c levels during treatment. As illustrated in Fig. 4, both ES and BFST-D yielded
substantial reductions in HbA1c among those with baseline levels above 9.0%. The magnitude of these changes is
considered to be quite significant clinically because these
reductions amount to an approximate 0.7 standard deviation difference relative to baseline for the ES group and a
0.8 standard deviation difference for the BFST-D group.
Hypothesis 4 was not submitted to statistical analysis because the frequencies of hospitalizations and emergency room visits were so low. The recorded 10
hospitalizations and 12 emergency room visits were distributed evenly across groups, and most of these events
were not diabetes related. Further follow-up of the sample for an additional year may clarify whether these
measures of health care utilization differ among the
treatment groups over a longer interval.
Overall, the study results suggest substantial promise for the revised BFST-D intervention for reducing
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Wysocki et al.
Acknowledgments
This study was supported by NIH grant 1-RO1-DK43802
to the first author and NIH grants P60-DK20579 and
RR00036 which support the Diabetes Research and Training Center and General Clinical Research Center at the
Washington University School of Medicine.
Received May 10, 2005; revision received July 5, 2005 and
August 1, 2005; accepted December 11, 2005
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