Methods
Participants
Caregivers of children with SCD were recruited from two comprehensive
pediatric SCD centers (Buffalo and Pittsburgh). Eligibility criteria
were: (1) primary caregiver of a child, from birth through 10 years of
age, diagnosed with any type of SCD; (2) English-speaking; and (3)
residing within 30 miles of the respective study
site.
Procedures
Medical care teams were informed about BI and previous research
demonstrating success (acceptability and effectiveness) amongst
caregivers of pediatric oncology patients. Medical providers then
approached eligible caregivers during the child’s routine outpatient
hematology appointments and/or inpatient admissions, to obtain
caregivers permission to be contacted regarding their interest in this
project (Figure 1). After obtaining consent, caregivers were asked to
complete baseline assessments (T1) and a time was scheduled to start BI
sessions.
B right
IDEAS Problem-Solving Skills Training
BI is an evidence-based manualized intervention, based foundationally on
the tenets of Problem-Solving Therapy23. In previously
published work, the intervention was titled Problem-Solving Skills
Training18,19 (PSST); however, during an ongoing
dissemination science grant, professionals trained to deliver the
intervention, as well as patient advocates, suggested that relabeling
the intervention (i.e., Bright IDEAS rather than PSST) would make it
more acceptable to families. In addition, professionals and advocates
felt the Bright IDEAS label was a more accurate depiction of the goals
of the intervention.
Bright signifies the concept of optimism (i.e., positive problem
orientation - You can do it ), which is essential to successful
problem-solving24.
‘IDEAS’ is a mnemonic for each of the BI problem-solving steps with each
letter signifying a step in the problem-solving process: I (Identify the
problem), D (Determine all possible options), E (Evaluate your options -
pros and cons of each option), A (Act - create an action plan based on D
and E), and S (See if it worked - if the plan does not work go back to
steps D and E respectively).
During BI sessions, participants are taught to utilize a five-step
approach to problem-solving18,19,20 (Figure 2). Over
the past 25 years of developing and assessing the effectiveness of BI, a
comprehensive instructor’s manual (Supplement 1: Instructor’s Manual)
was developed to serve as a guide for therapists when delivering the
intervention to caregivers. It was not changed for this research. For
this study, we modified the Cancer Parent Manual previously developed
for caregivers of children with cancer, to include relevant information
for caregivers of children with SCD (Supplement 2: SCD Parent Manual).
We also used BI worksheets (Supplement 3: Worksheets) during sessions,
as these materials contain attractive graphics and simplify the
problem-solving process for caregivers. The worksheets were not changed
for this research.
BI was presented to caregivers as a systematic approach that could be
used to overcome any life challenge, including those commonly faced when
caring for a child diagnosed with SCD. Following our template for
providing BI to caregivers of children with cancer, BI was delivered
over the course of 6-8 individual sessions, with each session following
a structured format, and lasting approximately 30-60 minutes. During the
first session therapists focused on: establishing rapport; learning
about the family and the child’s medical history; and explaining BI.
Caregivers were also provided a copy of the SCD Parent Manual and
Worksheets. During subsequent sessions (i.e., sessions 2-8) therapists
focused on: reviewing the BI program and worksheets; assisting
caregivers with identifying challenges; systematically guiding
caregivers through the problem-solving steps using the ‘IDEAS’ mnemonic;
and during the final session the principles of the program were reviewed
and strategies for relapse prevention were discussed.
Although the content of BI was identical to previous efforts with PSST,
in the current study, delivery times and locations were markedly more
flexible and determined based on the caregiver’s preference and needs to
reduce the impact of logistical barriers (e.g., lack of transportation,
reliable childcare, etc.) on participation. In prior BI studies within
pediatric oncology, sessions were primarily conducted during the child’s
hospitalizations or clinic visits. In the present study, our flexible
community-based approach was modeled after BI work with caregivers of
children recently diagnosed with autism25. BI sessions
were completed in a multitude of settings including home visits, meeting
at the caregiver’s work setting during lunch, Skype, and so on. Not only
could caregivers choose the location of each session, but they could
also select any time that worked for them, which included evening and
weekend sessions. Our ultimate goal was to make BI as accessible as
possible. Participants were also encouraged to use the BI Worksheets
between sessions (i.e., homework), but this was not required.
Measures
Measures were administered at three time points: (a) at baseline prior
to receiving BI (T1); (b) immediately following completion of 6-8 BI
sessions (T2); and three months following completion of BI sessions
(T3). Demographic information was only obtained at T1. Of note, attempts
were made via phone and/or email to obtain T2 and T3 data from
caregivers who did not complete the BI program.
Demographics
The demographic questionnaire included basic information about the
caregiver, the child with SCD, and the family system. Questions focused
on caregiver education, occupation, marital status, etc. Caregiver
socioeconomic status was determined using occupation and
education28,29.
Social
Problem-Solving Inventory-Revised (SPSI-R)
The SPSI-R is a 52-item self-report measure designed to assess an
individual’s ability to solve problems30. SPSI-R
statements are endorsed by respondents on a 5-point likert scale ranging
from 1 (i.e., not true at all) to 5 (i.e., extremely true). The SPSI-R
assesses positive problem orientation (PPO) and rational problem solving
(RPS), which are considered constructive/adaptive problem-solving
dimensions. Negative problem orientation (NPO), impulsivity/carelessness
style (ICS), and avoidance style (AS) are also measured and categorized
as dysfunctional problem-solving dimensions. A total score (0-20) is
calculated using the five sub-scores with consideration of whether the
sub-scores are constructive/adaptive or dysfunctional dimensions. Higher
total scores indicate that the individuals utilize constructive
problem-solving orientation and rational problem-solving styles more
frequently. The SPSI-R was used as a primary measure of intervention
efficacy. In previous research, the internal consistency of the SPSI-R
was found to be adequate when used with parents of children with SCD
(Cronbach’s α=0.86).17 In the current study, the
Cronbach’s α for the SPSI-R total score was .87. Cronbach’sα for the SPSI-R subscales were as follows; PPO .80, NPO .87, RPS
.95, ICS .79, and AS .78.
Patient
Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depressive
symptoms31. Each of the 9 items are rated on a 4-point
likert scale ranging from 0 (i.e., not at all) to 3 (i.e., nearly every
day) with respondents required to rate the frequency of the depressive
symptoms experienced within the last two weeks. Total scores range from
0 (no symptoms of depression) to 27 (i.e., severe depression). A score
of 15 and above is suggestive of clinical depression. The PHQ-9 was used
as a secondary measure of intervention efficacy. When used with an older
African American population the PHQ-9 Cronbach’s α was found to be
0.7532. In the current study, the PHQ-9 Cronbach’sα was .86.
Profile
of Mood States (POMS)
The POMS is a 65-item self-report measure consisting of seven
self-report rating scales about feelings experienced over the previous
week33,34. In the current study, we used a 15-item
short-form of the POMS, as in prior BI studies35. The
POMS items were rated from 0 (not at all) to 4 (extremely). The POMS
produces seven subscales: (1) tension-anxiety, (2) depression-dejection,
(3) anger-hostility, (4) fatigue-inertia, (5) confusion-bewilderment,
(6) vigor-activity, and (7) friendliness. The subscale scores were
combined to create a total mood disturbance (TMD) score. The POMS was
used as a secondary measure of intervention efficacy. In the current
study, the POMS TMD Cronbach’s α in the current sample was .85.
Impact
of Events Scale-Revised (IES-R)
The IES-R is a 22-item self-report questionnaire that includes three
subscales (i.e., hyperarousal, intrusion, and avoidance) that are
associated with post-traumatic stress disorder
(PTSD)36. Items are rated on a 4-point scale, based on
frequency of occurrence, ranging from “not at all” to “often.”
Higher scores indicate more symptoms of post-traumatic stress disorder.
The IES-R was used as a secondary measure of intervention efficacy. The
IES-R IES-R test-retest reliability estimates obtained from African
American breast cancer survivors ranged from 0.89 to 0.94 over a 6-month
study period37. In the current study, the Cronbach’sα for this sample was .93.
Data
Analysis
Descriptive statistics are provided for the demographic data. We
anticipated that caregivers would report higher levels of
problem-solving skills and lower levels of distress at T2 and T3
compared to T1. To analyze the changes in problem-solving skills and
distress over time, the SPSI-R, PHQ-9, POMS, and IES-R raw scores were
analyzed using Maximum Likelihood Estimation for unbalanced (i.e.,
incomplete) repeated measures. As in prior BI
studies18,19,20, this approach was chosen to avoid
making the assumption that data are missing-completely-at-random, which
occurs with case deletion when using traditional multivariate analysis
of variance. Thus, all caregivers, regardless of whether they completed
BI, were included in the “intent-to-treat” analyses. In addition,
because we had clear directional expectations, one-tailed t-tests are
reported. All data analyses were completed using IBM SPSS Statistics
Premium Grad Pack 25 for Mac.