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

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)

A contributing factor to caregivers’

depression and burden is inadequate

treatment of their child’s mental health

problems

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)

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)

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)

When depressive symptoms are

treated within primary care settings, it

is usually with medications and

assurance

(Lynch, Tamburrino, & Nagel, 1997; Mynors-Wallis, 1996)

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)

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

To determine the feasibility,

acceptability, & preliminary

estimates of effect sizes for the

BOSC intervention when compared

to a wait list control (WLC) group

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

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

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

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

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

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

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

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.

Participants endorsed having been

told by a mental health

professional that they had

schizophrenia, bipolar disorder,

substance abuse, or psychosis

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

• 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

• 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

BOSC

WLC

DC1 DC2 DC3

DC4

DC5

R

Intervention

Intervention

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

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

Partial eta was used to estimate

effect size using SPSS

Small = <.08

Medium = .09 - .24

Large = > .25

• 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

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

• 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

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

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

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)

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

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

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)

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

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

Not depressed Depressed

BOSC 18 12

WLC 18 13

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

Entire Sample (30 BOSC 31

WLC) Adjusted PES overtime for patients

with depression (12 BOSC 13 WLC)

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

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

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

• 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

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?

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

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?