randomized controlled trial of building our solutions and...
TRANSCRIPT
![Page 1: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/1.jpg)
Eric L. Scott, Ph.D., HSPP1
Janis Gerkensmeyer, PhD, PMHCNS-BC2
Susan Perkins, Ph.D.1
Ukamaka Oruche, PhD, PMHCNS-BC2 1Indiana University School of Medicine 2Indiana University School of Nursing
R21NR010593
Randomized Controlled Trial of Building our
Solutions and Connections (BOSC) Treatment
for Caregivers of Children Receiving Mental
Health Services
![Page 2: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/2.jpg)
About 1 out of 5 children in the US have
mental health problems, and mothers are
usually their primary caregivers
(National Institute of Mental Health, 2001)
Primary caregivers of children with mental
health problems have higher levels of
burden and/or depressive symptoms
compared to caregivers of children without
mental health problems
(Duchovic, Gerkensmeyer, & Wu, 2009)
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A contributing factor to caregivers’
depression and burden is inadequate
treatment of their child’s mental health
problems
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Services for these children have been
decreased in an effort to reduce costs
Consequently, parents are faced with
the increased responsibility to care for
children with very severe mental health
problems at home
(Grey, Knafl, & McCorkle, 2006)
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Caregivers’ depressive symptoms and
burden are frequently unrecognized
and unaddressed in the clinical setting
Elgar, McGrath, et al., 2004; Swartz, et
al., 2005, Tolen & Dodge, 2005)
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Few studies have addressed the well-
being caregivers of children with
mental health problems. A preliminary
study with 155 caregivers of 2 to 19
year-old children showed that 57.4%
had at least a moderate level of
depressive symptoms
(Gerkensmeyer, Perkins, Scott, & Wu,
2008)
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When depressive symptoms are
treated within primary care settings, it
is usually with medications and
assurance
(Lynch, Tamburrino, & Nagel, 1997; Mynors-Wallis, 1996)
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The BOSC Intervention is a cognitive-behavioral problem solving intervention (PSI), adapted from the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT Program)
(Hagel, M., Imming, J., Cyr-Provost, M., Noel, P. H., Arean, P., & Unutzer, J., 2002)
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BOSC Intervention (Coping)
•Problem-solving Intervention
•Cognitive Reframing
•Scheduled Pleasurable
Activities
Antecedents
(Stressors)
•Caregiver-Identified
Problems
Proximal Outcomes (Appraisal)
•Perceived Personal Control
•Problem Solving Attitudes &
Skills
Demographics
•Primary Caregiver
Characteristics
•Child Characteristics
Distal Outcomes
•Burden
•Depressive
Symptoms
Figure 1: BOSC Intervention Model
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To determine the feasibility,
acceptability, & preliminary
estimates of effect sizes for the
BOSC intervention when compared
to a wait list control (WLC) group
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a) At least 75% would complete at
least 7 of 9 PSI
b) Satisfaction ratings of the BOSC
PSI would be at least 3.0 on a 4-
point scale for 80% of participants
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c)Compared to the WLC group,
BOSC participants would report
higher perceived personal control,
improved problem-solving
attitudes and skills, lower
perceived burden, and less
depression
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An experimental design with an
intended randomization of 66
primary caregivers to either the
BOSC or WLC group
With an expected attrition rate of
30%, the goal was to have 25 in
each group completing the first 3
data collections
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BOSC began with a 1-hour face-
to-face training session with their
intervener, followed by up to 8
weekly 30 minute telephone
interventions
The PHQ-9 was used to monitor
participants’ well-being during
each session
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1. Evaluate outcomes from previous week
2. Select & define a problem
3. Establish realistic & achievable goals
4. Generate solution alternatives (brainstorm)
5. Examine pros and cons
6. Evaluate and choose solutions
7. Implement caregiver-selected alternatives
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On a scale from 1 to 10:
How challenging was the previous week
How satisfied they were with their efforts
How well participant met goals
If participant made good use of problem-
solving skills
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Interveners were trained using a
manual, listening to lectures, engaging in
role-plays, viewing a PSI training video,
& getting feedback about PSI
They audio-taped their phone
interventions for review by experienced
trainers & received feedback at ongoing
supervision sessions
Likewise, data collectors received
supervision
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Participants: (a) were the primary caregiver of
a child between ages 11 and 16 years who
received mental health services in the past
year, (b) were able to speak English, (c)
lived with the child for at least 20 of the past
24 months, (d) were either a biological ,
adoptive, or foster parent, a relative, or
guardian of the child, (e) met the standard
cut-off on the PHQ-9 and/or Burden
Assessment Scale & were at least 21 years
old.
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Participants endorsed having been
told by a mental health
professional that they had
schizophrenia, bipolar disorder,
substance abuse, or psychosis
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Random assignment to the BOSC or WLC
group
Blocked & stratified by level of child behavior
problems (>64 vs. <64 on CBCL Total
Behavior Problems T-score) & caregiver
depression (PHQ-9) or burden (both,
depression only, burden only), resulting in 6
strata
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• Data collectors were blinded to group assignment
• Data collection for both groups occurred at:
(a) baseline
(b) the week after the last of 8 weekly BOSC telephone interventions
(c) 3 months after BOSC group completed intervention
(d) 6 months after completing BOSC group intervention
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• Data collection occurred in stratified randomly assigned cohorts of 2 to 10 primary caregivers
• After the BOSC group completed the 3-month post-intervention data collection in a particular cohort, the WLC group began the intervention
• The WLC group cohorts had follow-up data collection the week after completing the 8 weekly calls and (at the same time) the BOSC group cohort completed a 6-month post-intervention data collection that provided an opportunity to examine if improvements were maintained over time
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BOSC
WLC
DC1 DC2 DC3
DC4
DC5
R
Intervention
Intervention
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See Table 1: Schedule of Assessments
(a) Demographics
(b) Child Behavior: CBCL
(c) Personal Control: Pearlin Mastery Scale
(d) Problem Solving: Social Problem Solving Inventory
(e) Depressive Symptoms: Beck Depression Inventory-II
(f) Burden: Parent Experiences Scale
(g) Acceptability of Intervention: Client Satisfaction
Questionnaire-9
(h) Process & dosage of BOSC: Interveners’ notes &
length and number of telephone calls
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Two-sample t-tests, chi-square, & Fisher’s exact tests used to compare demographic, screening & baseline variables between groups and subjects who dropped out prior to DC 3 & those completing study
ANCOVA used to test for group differences on each outcome variable
Separate models were fit at DC 2 and DC 3
Each model adjusted for baseline value of the outcome measure, baseline BDI, PES, Total CBCL, Total SPSI, & Personal Control scores
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Partial eta was used to estimate
effect size using SPSS
Small = <.08
Medium = .09 - .24
Large = > .25
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• 61 participants, 26-69 years; Average age = 42.7
• 59 (97%) female; 57% Caucasian, 39% African American, 1% each Pacific Islander or biracial
• Qualification into the study: 36 (59%) high burden, 3 (5%) high depression; 22 (36%) both high burden and depression
• No differences between groups based on
Demographics (age, sex, race) or
Baseline BDI, PES, Total CBCL, Total SPSI, & Personal Control scores
Those who dropped before DC3 & completed study
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H1: At least 75% would complete at least 7 of 9 PSI
Findings: BOSC (n = 30); 18 (60%) completed 7 of 9 PSI while 8 (27%) completed all 9 PSI. Mean # of PSI completed = 6.2 (median = 7.5)
H2: Satisfaction ratings of the BOSC PSI would be at least 3.0 on a 4-point scale for 80% of participants
Findings: Mean rating at DC 2 or end of 8th PSI = 3.5. 21 (78%) scored above 3
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• H3: Compared to the WLC group, BOSC
participants would report higher perceived
personal control, improved problem-solving
attitudes and skills, lower perceived burden,
and less depression
• Findings: Effect sizes were very small; the
only one in the medium range was for PES
or burden scores and it was statistically
significant
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Primary Analyses All Caregivers
n = 30 BOSC, n = 31 WLC
Data Collection 2 Data Collection 3
F p-value Effect
Size F p-value
Effect
Size
BDI .04 .841 <.01 .53 .470 .01
Pearlin
Personal
Control
.34 .562 <.01 3.37 .073 .07
Mean
PES 1.69 .200 .04 4.21 .046 .09*
Total
SPSI-R:L
Raw
Score
.91 .346 .02 .08 .777 <.01
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Conclusion:
PSI has little or no impact on (1)
problem solving attitudes and skills
or (2) on depression
PSI has some effect on burden
scores and may have some on
personal control
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2.67
2.32
2.13
2.78
2.52 2.45
0
0.5
1
1.5
2
2.5
3
3.5
4
DC 1 DC 2 DC 3
Mean PES/Burden
BOSC
Wait-list
Figure based on entire sample (n=30 BOSC, n=31 WLC)
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Combined Group PES/Burden Scores
2.6
2.35
2.27
2.1
2.2
2.3
2.4
2.5
2.6
2.7
Mean Mean Mean
Pre-visit (n=57) Post-visit (n=43) Follow-up visit (n=41)
Mean PES
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Figure based on entire sample (n=30 BOSC, n=31 WLC)
Pearlin Personal Control Scores
7.74 7.62 7.58
7.19 7.14
6.22
0
1
2
3
4
5
6
7
8
9
Mean Mean Mean
Data Collection 1 Data Collection 2 Data Collection 3
Pearlin BOSC
Pearlin Wait-list
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21.69 18.97
16.20
20.40 18.53
17.90
0
9
18
27
36
45
54
63
DC 1 DC 2 DC 3
BDI
BOSC
Wait-list
Figure based on entire sample (n=30 BOSC, n=31 WLC)
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Combined Group BDI\Depression Scores
20.05
16.4715.72
0
5
10
15
20
25
Mean Mean Mean
Pre-visit (n=57) Post-visit (n=43) Follow-up visit (n=41)
BDI
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Were effect sizes different between depressed and non-
depressed caregivers (depressed PHQ ≥ 10)?
• Findings:
Depressed caregivers had greater improvement in:
personal control (E.S.=.20 - medium) and
burden (E.S.=.21 - medium) compared to non-depressed
caregivers
• Conclusion:
It appears that for caregivers with depression, the BOSC
intervention helps decrease their burden and increase their
personal control
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Not depressed Depressed
BOSC 18 12
WLC 18 13
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Data Collection 2 Data Collection 3
Not
Depressed Depressed
Not
Depressed Depressed
Effect Size Effect Size Effect Size Effect Size
BDI <.01 .03 <.01 <.01
Pearlin Personal
Control <.01 .03 .04 .20
Mean PES .00 .30 .03 .21
Total SPSI-R:L Raw
Score .02 .12 .03 .00
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Entire Sample (30 BOSC 31
WLC) Adjusted PES overtime for patients
with depression (12 BOSC 13 WLC)
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Entire Sample (30 BOSC 31 WLC)
Adjusted PES overtime for patients with depression (12 BOSC 13 WLC)
7.747.62 7.58
7.19 7.14
6.22
0
1
2
3
4
5
6
7
8
9
Mean Mean Mean
Data Collection 1 Data Collection 2 Data Collection 3
Pearlin BOSC
Pearlin Wait-list
Pearlin Personal Control
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What are the effect sizes based on n = 19 participants (6 BOSC and 13
WLC) who were both depressed at baseline screening and complied with
the protocol (i.e. completed 7 of 9 intervention sessions)
Findings:
At DC3, medium effect size for burden (.21) and large effect size for
personal control (.59)
Effect size for depression approaches medium (.08)
Conclusion:
Depression did improve with time and with greater doses of treatment
Efficacy of intervention increased with greater compliance
![Page 43: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/43.jpg)
Data Collection 2 Data Collection 3
F p Effect
Size F p
Effect
Size
BDI .11 .748 .01 .85 .379 .08
Pearlin
Personal
Control .00 .988 .00 10.07 .016 .59
Mean
PES 6.13 .031 .36 2.61 .137 .21
Total
SPSI-R:L
Raw
Score
1.07 .323 .09 <.01 .964 .00
![Page 44: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/44.jpg)
• PSI has effect on personal control and
burden for depressed caregivers
• Interventions help if participants comply, but
highly speculative given the small sample
size in this preliminary analyses
• These findings indicate that the BOSC
intervention may be beneficial - particularly
targeting those individuals with high levels of
depression
![Page 45: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/45.jpg)
Future Research Questions
• Efficacy studies that are adequately powered
• What predicted tx discontinuation?
• How can we help people from dropping out?
MET?
• There was a trend toward decreased
depression among those with more
treatment. Would this continue at 9 or 12
months post-tx?
![Page 46: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/46.jpg)
Further Questions
• What role does behavioral activation play here?
• Toward what problem areas were caregivers applying the PSI? Caregiving role? Other domains?
• Could this be consumer driven?
• Could peer counselors be trained for treatment delivery?
• Feasibility of telehealth visits
![Page 47: Randomized Controlled Trial of Building our Solutions and ...cmhconference.com/files/presentations/session37-scott.pdfEric L. Scott, Ph.D., HSPP1 Janis Gerkensmeyer, PhD, PMHCNS-BC2](https://reader034.vdocument.in/reader034/viewer/2022050114/5f4b43dffd34af0497326ef2/html5/thumbnails/47.jpg)
Clinical
implications
• How can we systematic screening for
caregivers in MHC like well-baby
checks for post-partum depression?
• How can we pay for problem-solving for
each clinic visitor?