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Effects of Behavioral Family Systems Therapy for Diabetes

on Adolescents Family Relationships, Treatment Adherence,


and Metabolic Control
Tim Wysocki,1 PHD, Michael A. Harris,2 PHD, Lisa M. Buckloh,1 PHD, Deborah Mertlich,2
MSW, Amanda Sobel Lochrie,1 PHD, Alexandra Taylor,1 MA, Michelle Sadler,2 BSN, CDE,
Nelly Mauras,1 MD, and Neil H. White,2 MD, CDE
1

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

adolescence; diabetes; family therapy.

Family conflict, parentadolescent communication, and


problem-solving skills have been associated with diabetes outcomes among adolescents in cross-sectional
(Anderson, Miller, Auslander, & Santiago, 1981;
Bobrow, AvRuskin & Siller, 1985; Miller-Johnson et al.,
1994; Wysocki, 1993) and prospective (Gustafsson,
Cederblad, Ludvigsson & Lundin, 1987; Hauser et al.,
1990; Koski, Ahlas & Kumento, 1976) studies. Thus,
the development and validation of behavioral and psychological interventions that improve family communication, problem solving, and conflict resolution is
warranted and could enhance diabetes management
among adolescents and their families.
Behavioral family systems therapy (BFST) is a flexible, multicomponent, family-focused intervention that
targets family communication and problem solving,
extreme beliefs of parents and adolescents that impede

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

Behavioral Family Therapy in Diabetes

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.

18 months; and intent for the adolescent to remain living


in the same home for 18 months. Exclusion criteria
were: adolescent diagnosis of another systemic chronic
disease except well-controlled asthma or Hashimotos
thyroiditis; enrollment in self-contained special education; psychiatric admission of the adolescent within the
prior 6 months; caregiver who was illiterate or not fluent
in English; residence of adolescent in foster care, group
home, or correctional facility; no telephone service;
current diagnosis of psychosis, major depression, or
substance abuse disorder in an adult caregiver; or open
case with a child protection agency regarding child
abuse or neglect.
Figure 1 provides a summary of participants
progress through the various stages of the trial in the
format recommended by the Consolidated Standards for
Reporting Clinical Trials (CONSORT) (Begg et al.,
1996). An introductory letter was mailed to 577 families, and telephone follow-up was achieved with 438
(76%) of them. Of these, 48 (11%) were determined to
be ineligible by interview, while many others declined
participation before their eligibility could be ascertained.
A sample of 104 eligible families entered the study, 61 at
the Southeastern site and 43 at the Midwestern site, for a
recruitment rate of 27% of families who had not been
found to be ineligible. Demographic characteristics of
the sample are summarized in Table I and analyzed in
the Results section.

Charts Assessed for Eligibility


(n=577)

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

Telephone or Direct Contact Made


(n=436)

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)

Figure 1. Flow diagram of participants progress through the study per


the CONSORT criteria.

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Wysocki et al.

Table I. Demographic Characteristics of the Three Groups at Baseline


Variable

Youth age (years)

SC

ES

BFST-D

14.2 1.9

14.4 1.9

13.9 1.9

Diabetes duration (years)

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

Hollingshead SES index


Gender
Male

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

exercise plan. Adolescents and families were referred to


qualified psychologists or psychiatrists not associated with
the research team for services as needed.
Educational Support (ES)
In addition to the SC medical regimen, ES families attended
12 multifamily meetings within 6 months for diabetes education and social support. ES was designed to emulate a
common mental health service for families of chronically ill
teens and to serve as an alternative therapy comparison and
a control for the differential professional attention received
by the SC and BFST-D groups. Experienced diabetes nurses
served as facilitators at each site and received extensive
training before conducting ES sessions. Groups of three to
five families completed a 12-session series together,
attended by the parents and adolescents with diabetes. Session content followed the chapters of an American Diabetes
Association curriculum for teens (Johnson, 2000). The
same materials and session outlines were used at both sites,
and the facilitators spoke weekly by telephone to ensure
cross-site consistency. Family communication and conflict
resolution skills were excluded from session content
because these were specifically targeted by BFST-D. Sessions included a 45-min lecture by a health professional on
1 of the 12 topics, followed by 45 min of family interaction
about that topic led by the facilitator.
Behavioral Family Systems Therapy for Diabetes
(BFST-D)
In addition to the SC medical regimen, families in this
group received 12 BFST-D sessions over 6 months. Sessions
were conducted by one of three psychologists at the southeastern site or a licensed clinical social worker at the Midwestern site and were attended by the youth with diabetes
and their caregivers who were participants. Therapists were
trained and certified as proficient in BFST-D by two experienced, licensed psychologists (the first two authors) before
enrollment of families. Methods described later in the article assured treatment integrity throughout the study.
BFST-D consisted of four components: problemsolving training, communication training, and cognitive
restructuring and functional-structural family therapy.
Problem-solving training provided families with a structured problem-solving approach with discrete steps consisting of: problem definition, generation of solutions,
group decision making, planning, implementation and
monitoring of the selected solution, and renegotiation or
refinement of ineffective solutions. Communication skills
training included instructions, feedback, modeling, and
rehearsal targeting common parentadolescent communication errors. Cognitive restructuring methods targeted family members irrational beliefs, attitudes, and

Behavioral Family Therapy in Diabetes

attributions about one anothers behavior that could


impede effective parentadolescent communication. Functional and structural family therapy interventions targeted
anomalous family systemic characteristics (e.g., weak
parental coalitions and cross-generational coalitions) that
could impede effective problem solving and communication. Families received the intervention components that
were appropriate to their needs as determined by baseline
assessments and ongoing observations in therapy. Sessions
consisted of family problem solving and conflict resolution
discussions. Therapists participated actively, frequently
providing instructions, feedback, modeling, and rehearsal.
Behavioral homework was assigned at each session and
reviewed at the next session. Each session included delivery of some didactic information and emphasized teaching
the family to acquire and apply the targeted skills at home.
The revised BFST-D intervention utilized in this study
included these diabetes-specific adaptations:
1. All families targeted for treatment two or more
diabetes-related problems that were identified as
barriers to diabetes management or control.
These behaviors were identified during the first
two BFST-D sessions.
2. Explicit training in behavioral contracting was
provided (Carney, Schechter, & Davis, 1983;
Epstein et al., 1981; Schafer, Glasgow & McCaul,
1982; Wysocki, Green & Huxtable, 1989). These
studies have confirmed that behavioral contracting improves adolescents adherence to specific
targeted aspects of the diabetes regimen. Behavioral contracts were evaluated and refined as
needed in subsequent sessions.
3. All families received advanced education in using
SMBG data to modify insulin, diet, or exercise to
improve diabetic control. The CDE and therapist
conducted BFST-D sessions 6 and 7 jointly. The
CDE provided education and training in using clinical algorithms for these purposes. The therapist
helped families use their improved communication
and problem-solving skills to facilitate this. Treatments with similar components have improved diabetic control (Anderson, Wolf, Burkhart, Cornell,
& Bacon, 1989; Delamater et al., 1990).
4. Parents simulated living with diabetes for 1 week
between sessions 7 and 8. Satin, La Greca, Zigo, &
Skyler (1989) showed that this intervention produced broad cognitive and affective benefits, and it
is compatible with the BFST incorporation of cognitive restructuring methods. This included multiple daily injections of sterile saline on the childs

insulin schedule; daily blood glucose checks on


the childs schedule; monitoring and regulating
carbohydrate intake; and managing one simulated
hypoglycemic event (parents were notified by the
therapist to indicate onset of hypoglycemia).
5. Therapists could extend the intervention to other
social networks affecting the youths diabetes care
by involving peers, siblings, teachers, or others
and conducting sessions in other locations if necessary (Henggeler, Schoenwald, & Pickrel, 1995).

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).

Measurement Methods and Schedule


Measures were collected at a baseline evaluation preceding
randomization. Some measures were collected at baseline
only for evaluation as moderators of treatment outcome,
and those are not described in detail here since they were
not included in the analyses for this article. These measures
included the Brief Symptom Inventory (DeRogatis, 1977),
Millon Adolescent Clinical Inventory (Millon, Millon, &
Davis, 1997) and the Family Assessment Device (Kabacoff,
Miller, Bishop, Epstein, & Keitner, 1990). Analyses pertinent to these measures will be the topic of a future report.
The General Information Form yielded demographic and medical information and the data that were
needed to calculate the Hollingshead index of social status (1975, unpublished manuscript).
The following measures were collected at baseline
and at the end of treatment (6 months):
The ParentAdolescent Relationship Questionnaire
(PARQ)
PARQ assesses the primary constructs of the behavioral
family systems model (Robin, Koepke & Moye, 1990). It
yields norm-referenced standard scores for three factor
analytically derived scales: overt conflict/skill deficits,
extreme beliefs, and family structure. There are separate
forms for adolescents (314 truefalse items) and parents
(280 items). Internal consistency ranged from .73 to .89
for this sample. The proportions of study participants
whose scores were at or above a clinical cut-off of T = 65
on overt conflict/skill deficits were 2.8% for adolescents,

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Wysocki et al.

2.0% for mothers, and 7.1% for fathers. For extreme


beliefs, the corresponding proportions of scores above
the clinical cut-off were 9.2, 2.0, and 4.3%, respectively.
Finally, for family structure, clinically significant
scores were obtained for 4.7, 3.8, and 1.7% of adolescents, mothers, and fathers, respectively.
The Diabetes Responsibility and Conflict Scale (DRC)
DRC assesses parentchild division of diabetes responsibilities and family conflict about 15 diabetes-related
tasks (Rubin, Young-Hyman, & Peyrot, 1989). Internal
consistency ranged from .86 to .92 for this sample.
The Diabetes Self-Management Profile (DSMP)
DSMP is a structured interview for the assessment of diabetes treatment adherence that was adapted from methods
developed by Hanson, Henggeler, & Burghen (1987). The
revised interview incorporates introductory comments
designed to normalize the difficulty of regimen adherence.
Questions were re-worded to enhance the ability to capture
flexible diabetes self-management as it is currently practiced (e.g., insulin pump therapy). The revised interview
(Harris et al., 2000) consisted of 24 adherence questions
regarding 5 regimen domains (insulin, blood glucose testing, diet, exercise, and management of hypoglycemia).
Internal consistency based on the present sample was .79
with 6-month testretest reliability of .58. Scoring reliability
across independent raters was .95. Total scores did not differ between parents and adolescents interviewed separately,
and the correlation between parent and adolescent scores
was r = .45 (p < .001). Baseline DSMP total scores correlated significantly with HbA1c levels with r = .29 (p < .01).
Glycosylated Hemoglobin (HbA1c)
HbA1c was measured quarterly at routine clinic visits with
the DCA-2000 system (Bayer Diagnostics, Tarrytown, NY,
USA). Assays completed at the two sites had been standardized against a reference laboratory, and the results
confirmed its accuracy and consistency. The equivalence
of DCA-2000 and reference laboratory measurements was
also confirmed in a recent study (Diabetes Research in
Children Network Study Group, 2005).

Assurance of Procedural Consistency and Integrity


Several methods ensured cross-site consistency of study
procedures. A detailed operations manual described
each study procedure. A previously prepared BFST manual
was revised to reflect the BFST-D changes. The ES intervention was also guided by a manual (Johnson, 2000).
Clinicians implementing the BFST-D and ES interventions spoke weekly by phone to plan intervention delivery.
Additional efforts assured the integrity of BFST-D. A

second therapist rated videotapes of each BFST-D


session for treatment fidelity. The ratings were discussed
in weekly phone conferences and deviations were
resolved. The vast majority of ratings affirmed the integrity of the BFST-D intervention. Virtually all issues that
were raised reflected legitimate differences in clinical
judgment rather than violations of the written protocol.

Data Management and Statistical Analysis Plans


Research assistants checked all measures for appropriate
completion before families left the evaluation session and
corrected any administration errors. Data were then
entered into a computer data file on a local area network
at one of the centers. Data were checked for normality of
distributions and for outliers or data entry errors before
analyses. Statistical analyses began by comparing the
groups at baseline on demographic and outcome variables. Since baseline HbA1c was correlated significantly
with many of the outcome measures obtained at baseline,
the general analysis plan for each outcome measure was
to treat experimental groups (SC, ES, and BFST-D) and
baseline HbA1c (above or below the median value of
9.0%) as between-subjects factors in repeated measures
analyses of variance. The number of adolescents in each
group with HbA1c <9.0% and 9.0%, respectively, was
SC: 16 and 16; ES: 17 and 19; and BFST-D: 18 and 18. For
analyses of treatment effects on HbA1c, the dependent
variable was change in HbA1c from baseline to 6 months.
To reduce the number of statistical comparisons, PARQ,
DRC, and DSMP scores from adolescents and parents
were combined to form family composite scores for these
measures that were then submitted to statistical analyses.
In all of these cases, family members scores were significantly correlated, with r-value ranging from .37 to .63.

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

Behavioral Family Therapy in Diabetes

Hypothesis 1 (Family Relationships and Conflict)


Table II summarizes that change in PARQ family composite T scores from baseline to 6 months did not differ significantly among treatment groups for the overt conflict/skill
deficits, extreme beliefs or family structure subscales. Neither the main effect for group nor the group time interaction effect was statistically significant. Hypothesis 1 was
therefore not confirmed relative to effects on the PARQ.
Mean DRC family composite scores for each group
at baseline and 6 months, respectively, were SC: 25.9 and
29.4; ES: 29.4 and 32.1; and BFST-D: 27.5 and 26.9. The
increase in DRC scores in the SC and ES groups and
slight decrease for the BFST-D group yielded a significant
group time interaction effect [F(2,89) = 4.31; p <.02].
Further, a significant group timebaseline HbA1c
interaction [F(2,87) = 3.27; p <.04] indicated that this
treatment effect varied in magnitude as a function of
baseline HbA1c level. Figure 1 portrays this interaction
graphically by presenting change in family composite
DRC scores from baseline to 6 months for youths with
HbA1c above and below the median baseline level (9.0%)
for each group. BFST-D yielded significantly greater
reduction in DRC scores than either of the other two
Table II. Mean (SD) family Composite Scores on the PARQ Subscales
for Each Treatment Group at Baseline and 6 Months
PARQ scores at baseline
Overt conflict/
Skill deficits

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

PARQ scores at 6 months

There were no statistically significant between-group differences at baseline or


6 months and the group time interaction effect was not statistically significant.

groups, and this effect was limited to those with baseline


HbA1c above 9.0%. Hypothesis 1 was therefore confirmed with respect to differential treatment effects on
DRC scores, although this effect occurred only for those
in the poorest diabetic control at baseline, and the effect
is best described as attenuation by BFST-D of worsening
conflict that occurred among the comparison groups.

Hypothesis 2 (Treatment Adherence)


Mean treatment adherence (DSMP) scores obtained for
each group at baseline and 6 months, respectively, were
SC: 53.0 and 51.4; ES: 55.2 and 54.6; and BFST-D: 54.7
and 57.4. The main effect for groups and the group time
interaction effect failed to achieve statistical significance.
However, there was a significant group time baseline
HbA1c interaction effect [F(2,89) = 3.63; p <.03]. Figure 2
illustrates change in DSMP total scores from baseline to
6 months as a function of treatment group and baseline
HbA1c. Post-hoc analyses showed that BFST-D yielded
significantly greater improvement (or less decline) in
treatment adherence relative to both of the other treatment groups and within both baseline HbA1c ranges.
Hypothesis 2 was therefore confirmed with respect to
superiority of BFST-D over the other treatment groups
in terms of effects on treatment adherence.

Hypothesis 3 (Glycemic Control)


Mean HbA1c levels at baseline and 6 months, respectively, were SC: 9.5 and 9.2%; ES: 9.7 and 8.9%, and
BFST-D: 9.6 and 8.8%. Neither the main effect for groups
nor the group time interaction effect were significant. But,
6-Month Change in DRC Family Composite Score

who were randomized, 92 (29 SC, 35 ES, and 28 BFST-D)


completed the baseline and 6-month evaluations
reported in this article. The 12 dropouts did not differ
significantly at baseline from those who completed the
study in terms of any outcome measure analyzed for this
paper. Compared to those who completed the study,
dropouts had significantly lower SES (mean Hollingshead index = 41.5 versus 30.7) and were significantly
less likely to be living with both biological parents (45
versus 25%). There were no statistically significant differences across sites or therapists on any of the outcome
measures at baseline or 6-month follow-up.

Baseline HbA1c Levels


<9.0%

>9.0%

7
5
3
SC
ES
BFST-D

1
-1
-3
-5
-7
(Lower scores = less family conflict)

Figure 2. Mean change in diabetes-related conflict (DRC) scores from


baseline to 6 months for the standard care (SC), educational support
group (ES), and behavioral family systems therapy for diabetes (BFST-D)
groups reported separately for youths with glycosylated hemoglobin
(HbA1c) <9.0% and 9.0%. Lower scores indicate reduced diabetesrelated family conflict. The group time interaction effect (p < .02) and
group timebaseline HbA1c interaction effect (p < .04) were
statistically significant. Post-hoc analyses showed that effects of BFST-D
were significantly greater among those with HbA1c > 9.0%.

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Wysocki et al.

Baseline HbA1c Levels


<9.0%

Baseline HbA1c Levels

>9.0%

5
4
3
2
1
0
-1

SC
ES
BFST-D

-2
-3
-4
-5
(Higher scores = better adherence)

Figure 3. Mean change in the diabetes self-management profile


(DSMP) scores from baseline to 6 months for the standard care (SC),
educational support group (ES), and behavioral family systems
therapy for diabetes (BFST-D) groups reported separately for youths
with glycosylated hemoglobin (HbA1c) <9.0% and 9.0%. Higher
scores indicate improved diabetes self-management behaviors. The
group timebaseline HbA1c interaction effect was statistically
significant (p < .03). Post-hoc analyses showed that BFST-D yielded
more improvement in DSMP scores than the ES and SC groups in
both baseline HbA1c ranges.

as illustrated in Fig. 4, the group time baseline HbA1c


interaction effect were statistically significant [F(2,89) =
3.17; p <.05]. Although HbA1c tended to decline somewhat
for all three treatment groups, post-hoc comparisons
showed that, among those with baseline HbA1c above 9.0%,
improvement in HbA1c was significantly greater for both
the BFST-D (1.3%) and the ES groups (1.1%) than for the
SC group (0.4%). Figure 3 portrays the interactive effects
of the treatments on change in HbA1c as a function of baseline HbA1c. The difference between the ES and BFST-D
groups did not achieve statistical significance. Hypothesis 3
was therefore partially confirmed in that BFST-D was superior to the SC group, but not the ES group, in terms of
improving metabolic control during the study. The benefits
of both ES and BFST-D were most evident for those with
poor metabolic control at baseline (Fig. 4).

Hypothesis 4 (Health Care Utilization)


Participants had 10 hospitalizations and 12 emergency
room visits during the 6-month study. Hospital admissions
for each group were SC: 4; ES: 3; and BFST-D: 3. Emergency room visits for each group was SC: 4; ES: 5; and
BFST-D: 3. Inferential statistical analysis was inappropriate
due to the very low frequencies of these events and because
13 of the 22 episodes were not related directly to diabetes.

Discussion
This article reports the immediate posttreatment results
of a randomized controlled trial comparing SC for diabetes

6-Month Change in HbA1c (%) + 1 SEM

6-Month Change in DSMP Total Score + 1SEM

934

<9.0%

>9.0%

0.5
0

SC
ES
BFST-D

-0.5
-1
-1.5
-2
(Lower scores = improved metabolic control)

Figure 4. Mean change in HbA1c from baseline to 6 months for the


standard care (SC), educational support group (ES), and behavioral
family systems therapy for diabetes (BFST-D) groups reported
separately for youths with HbA1c <9.0% and >9.0%. Lower scores
indicate improved metabolic control. The group timebaseline
HbA1c interaction effect was statistically significant (p < .05). Posthoc analyses showed that both BFST-D and ES yielded more
improvement in HbA1c compared to SC and that this was limited to
youths with baseline HbA1c 9.0%.

mellitus alone to augmentation of SC by 6 months of


family participation in either a 12-session multifamily
ES or to 12 sessions of BFST-D. The BFST-D treatment
had been revised in response to a previous trial in an
effort to enhance the effects of the intervention on treatment adherence, glycemic control, and health care utilization (Wysocki et al., 1997, 1999, 2000, 2001).
Effectiveness of this revised BFST-D intervention relative to the SC and ES conditions was evaluated by comparing change in four sets of outcome measures over
6 months of treatment. Overall, the results yielded support for the hypothesized effectiveness of BFST-D and
suggested that the refinements made to the previously
tested intervention did enhance the interventions
impact on certain diabetes outcomes. This adds to a
growing literature describing other empirically validated
interventions for this population (Anderson et al., 1989;
Delamater et al., 1990; Ellis et al., 2005; Ellis, NaarKing, Frey, Rowland & Greger, 2003; Grey, Boland,
Davidson, Li, & Tamborlane, 2000; Hampson et al.,
2001; Laffel et al., 2003) by showing that BFST-D
yielded significant benefits to adolescents and their families in terms of several diabetes-specific outcomes.
Hypothesis 1 predicted that BFST-D would yield
significantly greater improvement in parentadolescent
relationships (PARQ scores) and diabetes-related family
conflict (DRC scores) compared to SC or ES. Hypothesis 1
was partially confirmed since significant group time
and group time baseline HbA1c interactions were
obtained. Diabetes-related family conflict was decreased
slightly during treatment for the BFST-D group, whereas
it increased for the SC and ES groups during the same

Behavioral Family Therapy in Diabetes

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

family conflict about diabetes and for improving treatment


adherence and metabolic control. The observation that
these effects were more evident for families of those
youths entering the study with poor metabolic control is
encouraging, because these are the youths who often
endure prolonged maladjustment to diabetes and a
downward spiral of poor metabolic control, psychiatric
disorders, acceleration of long-term complications, and
excess health care costs (Bryden et al., 2001; Wysocki,
Hough, Ward & Green, 1992).
Mechanisms that may account for the stronger
BFST-D treatment effects on HbA1c and diabetes-related
family conflict (DRC scores) among families of adolescents with poor metabolic control at baseline remain to
be identified. Possibly, specification of treatment targets
with such adolescents and their families may be more
obvious than for those whose diabetes-management difficulties are somewhat less salient. When families
exhibit glaring problems with diabetes management,
modest behavior change may yield more pronounced
benefits that might be less evident for families with
slightly more competence. Stated another way, adolescents in very poor metabolic control before treatment
may simply have had more room for improvement in
both self-management behaviors and glycemic control.
Whether these or other explanations prove accurate, it is
encouraging that adolescents with poor metabolic control enjoyed clinically meaningful treatment gains
through BFST-D.
Certain limitations of the study should be noted.
The feasibility of delivery of BFST-D in most clinical settings, especially given the constraints imposed by the
health care economy, is questionable. The study was
conducted under optimal circumstances that are
unlikely to exist in typical clinical settings. Participants
were paid for completing study evaluations, intervention
sessions were provided without charge, and substantial
flexibility in appointment times was offered to make
engagement in therapy as convenient as possible. These
features are unlikely to be feasible in most pediatric settings. Future research on BFST-D should focus on optimizing its cost effectiveness through such mechanisms
as reducing the number of sessions, evaluating delivery
to multiple families concurrently rather than to individual families, or supplementation of BFST-D sessions via
internet or interactive telecommunication methods.
Other important limitations relate to sampling and
retention. The sample size was relatively small for a trial
of this type, and 88% of the sample completed both evaluations. As a consequence, the cell sizes for certain of the
interaction effects reported in this article were sometimes

935

936

Wysocki et al.

small, increasing the likelihood that spurious effects


would prove to be statistically significant. However, the
benefits of BFST-D to those with poor metabolic control
were confirmed across three different outcome measures
including questionnaires (DRC), structured interviews
(DSMP), and biochemical assays (HbA1c). The consistency of these findings across different outcome measures and methods bolsters confidence that these were
not spurious results.
Also, the selective benefits from BFST-D accruing to
those with poor baseline metabolic control were identified through secondary data analyses and were not
stated as a priori scientific hypothesis. Confidence in
these findings and the conclusions drawn from them
would be stronger had these observed relationships been
hypothesized in advance.
Finally, the present article evaluated a complex
intervention with multiple components. Consequently,
dismantling studies to identify the critical elements of
BFST-D may prove difficult.
The present article addresses only the immediate
treatment effects of BFST-D on the various outcomes.
Although the previous trial (Wysocki et al., 1997, 1999,
2000, 2001) demonstrated lasting treatment effects on
measures of parent-adolescent relationships, diabetesrelated family conflict, and treatment satisfaction, the
durability of the treatment effects reported here remains
to be confirmed. Follow-up of the present sample for an
additional 12 months after treatment will be the topic of
subsequent reports.

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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