Randomized controlled trial of combined caring vs nurse caring, self-caring, or no treatment on how partners perceived themselves, their couple relationship, and their partner's caring during the first year after miscarriage.

Kristen M. Swanson, RN, PhD, FAANGeorge Knafl, PhDSchool of NursingUniversity of North Carolina at Chapel Hill

BACKGROUND

• At least 1 in 6 pregnancies end in miscarriage: the unplanned, unexpected loss of pregnancy prior to 20 weeks gestation (Ventura et al, 1999).

• Both men and women grieve after loss, with depth and duration of women’s grief tending to be greater (Swanson et al, 2009).

• When asked what was lost, typically mothers say their baby; spouses say their partner (Wojnar et al, 2011).

• One year after loss approx. One-third of women claim their couple and / or sexual relationships are more distant than before their miscarriage (Swanson et al, 2003).

Are there differences in how partners perceive themselves, their couple relationship, and their partner's caring during the first year after miscarriage based on whether couples received Nurse Caring, Self Caring, Combined Caring, or no treatment?

RESEARCH QUESTION

Couples Miscarriage Healing Project

Kristen M. Swanson, RN, PhD, FAANGeorge Knafl, PhD

Carolyn Huffman RN, MSN, AWHNPAnthippy Petras, MSW

Danuta Wojnar, RN, PhDHsien-Tzu Chen, RN, PhDRosalie Houston, RN, MN

Susan Sandblom, ARNP, MNJeannette Quaeck, RN, MN

Appalachia Martine, RN, BSNHelga Fridjonsdottir, RN, PhD

Alyson Shapiro, PhDChristopher Graham, PhD

CMHP TEAM

1 R01 NR 05343-01A1

RECRUITED• Posters, ads (newspaper, radio), provider referral SELECTION CRITERIA• Miscarried w/in last 3 mos.• In a committed relationship• Speak / write English• If not married, both must be 18• Both parents consent and return baseline data

RECRUITMENT

ENROLLMENT(January, 2003 to June, 2006)

Screened• 418 volunteers

Eligible• 393 couples

Enrolled• 341 couples

Retained• 324 couples

Women Men

Age 32.4 33.9 *

College Education 91% 87%

Caucasian 84% 86%

Employed 69% 87% *

Mental Health Tx 49% 26% *

DEMOGRAPHICS

• Together (M = 6.9 yrs; SD = 4.5)• Children (range = 0 to 6)

(0 = 53%; 1 = 31%)• Miscarriages (range = 1 to 6) (1 = 68%)• Pregnancy planned 72%• Pregnancy wanted 98%• Ges. age at loss (M = 9.8 wks; SD = 3.1)

COUPLES

• PROCESS (Swanson Caring Theory)• CONTENT (Meaning of Miscarriage Model)• Four Arms

– Nurse Caring (3 counseling sessions)– Self Caring (3 videotape & workbook modules)– Combined Caring (1 counseling & SC modules)– Control (no treatment)

INTERVENTION

Phonescreen

randomized

nurse

self

combined

control

t2 t3 t4

1 5 11 weeks

Baseline

X X X

X X X

X X X

1 mo. 5 mos.3 mos. 13 mos.

Time since miscarriage

DESIGN

MEASURES

Men WomenTotal .888 - .917 .901 - .931Emotional .811 - .860 .863 - .902Social .707 - .760 .729 - .799Sexual .795 - .843 .749 - .803Intellectual .756 - .804 .797 - .843

Total .876 - .902 .885 - .906Emotionally Strong .850 -.886 .848 - .899Satisfied .784 - .831 .798 - .875

Total .848 - .876 .895 - .905Mutual Sharing .795 - .847 .882 - .888Cares for Me .817 - .869 .826 - .881

SELF How I See Myself (Swanson)

PARTNER CARING

How My Mate Cares

(Swanson)

Chronbach alphaMeasure ScalesConcept

INTIMACYPAIR

(Shaefer & Olson, 1981)

• 1,739 PAIR Total measurements• for 636 subjects

• 321 women• 315 men

• from 324 families• from 1-6 PAIR Total measurements per

couple

DATA

• Elapsed days since loss• Controlled for baseline values• PAIR Total used to determine the analysis

model that best fit the data

ANALYSIS

1. Started with most complex model including all main effects and all interaction effects. (used to select covariance structure)

2. Guided by Cross Validation (CV) values, reduced the model systematically to obtain best fit model.

3. Best fit model deployed to analyze all other scales and subscales.

MODEL REFINEMENT

Selected Covariance Structure• Covariance structure selection was based on a 2-

dimensional structure (time and spouse)• correlation between partners

– at the same time had estimated value 0.30– decreased as time between measurements increased

• correlation across time within partner– 10 weeks apart had estimated value 0.46– decreased as time between measurements increased

• standard deviations increased over time– but same for partners at each time

Main effects

group (4 levels) p = 0.337gender (2 levels) p = 0.585elapsed days since loss (continuous) p = 0.396

All two way interactions group X gender p = 0.673group X elapsed days p = 0.796gender X elapsed days p = 0.449

Three way interactiongroup X gender X elapsed days p = 0.973

Baseline value p < 0.001

Conclusion: Only baseline value is significant.

Question: Might some non-significant terms be masking effects of other terms?

STEP 1: FULL MODEL

Eliminated all interaction effectsGenerated an improved CV score, so better modelMain effects

group (4 levels) p = 0.198gender (2 levels) p = 0.463elapsed days since loss p = 0.101

Baseline value p<0.001

Conclusion: On a one to one comparison, no group stood out as significantly different.

Question: Might there be a better way to compare groups? One group vs. all others, two groups vs. two groups, etc.?

STEP 2: ADDITIVE MODEL

Sought best CV score for all possible combinations of the 4 groups into subgroups

Main effectsCombined Caring (CC) versus all others p = 0.042

mean post-baseline Pair Total increased by an estimated 1.9 units for CC vs. all other groups

gender (2 levels) p = 0.461elapsed days since loss p = 0.103

Baseline value p < 0.001

Conclusion: There was a significant positive effect for combined caring vs. all other groups that was masked in prior models.

Question: Does using this model selected for Total Intimacy lead to similar conclusions for other measures?

STEP 3: REFINED GROUP EFFECT MODEL

COMBINED CARING vs ALL OTHER GROUPS

RESULTS

estimates when significant

variableN of

families

N of post-baseline measures

gender (male)

combinedelapsed

time since loss

baseline value

gender (male)

combinedbaseline

value

PAIR Total 324 1769 0.461 0.042 0.103 <0.001 1.90 0.80emotional 324 1770 0.182 0.034 0.314 <0.001 0.70 0.73

social 324 1769 0.268 0.965 0.098 <0.001 0.72sexual 324 1769 0.049 0.049 <0.001 <0.001 -0.43 0.65 0.70

intellectual 324 1769 0.975 0.009 0.828 <0.001 0.73 0.75

Total 324 1779 0.812 0.032 <0.001 <0.001 1.10 0.67emo. strength 324 1779 0.877 0.145 0.001 <0.001 0.67

satisfied 324 1779 0.818 0.010 <0.001 <0.001 0.62 0.60

Total 323 1767 0.552 0.004 0.007 <0.001 1.59 0.63cares for me 324 1769 0.926 0.100 0.880 <0.001 0.62

mutual sharing 323 1767 0.242 0.001 <0.001 <0.001 0.97 0.54

INTIMACY

SELF

PARTNER CARING

p-values for fixed effects

Combined Caring vs All Other Groups

DISCUSSION & CONCLUSIONS

Should Miscarriage be studied as an occasion for adjustment, recovery, or growth?

Transition: CMHP findings for GriefWOMEN - (CC = NC = SC) > (control) MEN - (CC = NC) > (SC and control)

Pathology: CMHP findings for DepressionWOMEN - NC > (CC, SC, controlMEN - (NC = control) > (SC = CC)

Growth: CMHP findings for RelationshipsCC > (NC, SC, control)

1. During the first year after miscarriage, compared to those receiving NC, SC, or no treatment, men and women receiving CC rated their partner as more caring and they experienced less decline in their relational intimacy and perception of self.

2. Findings suggest that CC empowered couples to turn to each other as they resolved their miscarriage.

CONCLUSIONS

References

Shaefer, M. T. & Olson, D. H. (1981). Assessing intimacy: The PAIR Inventory. J of Marital and Family Therapy, 7, 47-60.

Swanson, K. M. (1991). Empirical Development of a middle range theory of caring. Nursing Research, 40, 161-166.

Swanson, K. M., Chen, H. T., Graham, J. C., Wojnar, D. M.. & Petras, A. (2009). Resolution of depression and grief during the first year after miscarriage: A randomized controlled clinical trial of couples-focused interventions. J Women’s Health and Gender-based Medicine, 18(8), 1245-1257.

Swanson, KM, Karmali, Z, Powell, S. & Pulvermahker, F. (2003). Miscarriage effects on interpersonal and sexual relationships during the first year after loss: Women's perceptions. J of Psychosomatic Medicine, 65(5), 902-10.

Ventura, S. J., Mosher, W. D., Curtin, M. A., Abma, J. C., Henshaw, S. (1999). Highlights of trends in pregnancies and pregnancy rates by outcome: Estimates for the United States, 1976-96. USDHHS National Vital Statistics Report 47(29).

Wojnar, D., Swanson, K. M., Adolfsson, A. (2011). Confronting the inevitable: A conceptual model of miscarriage for use in clinical practice and research. Death Studies, 35(6), 536-558(23).

• Model selection was independent of p-values• Based on cross validation (CV) scores

– Data randomly partitioned into subsets– Subsets predicted using parameter estimates

based on the rest of the data– Predictions combined into a score– With larger CV scores indicating better models

MODEL SELECTION