DNP 899 Module 2 Clinical Significance Beyond P Values Example

Below the Line and Stayed There? Clinical Significance in a Maternal Depression Screening Program at Well-Child Visits

Student Name

Doctor of Nursing Practice Program, Aspen University

DNP 899: DNP Project Capstone

Instructor Name

Month Day, Year

Below the Line and Stayed There? Clinical Significance in a Maternal Depression Screening Program at Well-Child Visits

A p value answers whether a change is unlikely to be chance. It does not answer whether the change matters to a mother holding a two-month-old at three in the morning. This paper examines the clinical significance of my DNP project, in which a pediatric practice began asking every mother about her mood during her baby's early checkups and sent those who screened positive straight to the social worker down the hall. It moves from statistical results to three kinds of clinical meaning: meaningful change for individual mothers, connection to care, and safety. It ends with the limits that shape each claim.

The Statistical Results

Over 16 weeks, 1,042 of 1,212 eligible visits included a completed Edinburgh Postnatal Depression Scale, the ten-item questionnaire developed to screen for postnatal depression in community settings and found sensitive to change over time (Cox et al., 1987). Of those screens, 118 scored 10 or higher. Sixty-four of the 118 mothers completed the scale again at the next well-child visit, four to eight weeks later. Their mean score fell from 14.2 to 9.1, a mean change of 5.1 points with a standard deviation of 4.4, t(63) = 9.27, p < .001. By conventional standards that is a large and highly significant change. It says little, however, about how many individual mothers improved in a way they would notice.

Reliable and Clinically Significant Change

Jacobson and Truax (1991) proposed two tests for meaningful change in an individual: whether the change is larger than measurement error alone would produce, their reliable change index, and whether the person moves from the range of the affected population into the range of the unaffected, such as crossing a clinical cut-off. The project applied both to the 64 rescreened mothers. The scale's reliability in this sample could not be estimated from two time points, so a conservative reliability of 0.80 was assumed; with the group's baseline standard deviation of 3.1, a change of about four points or more counts as reliable. By that standard, 41 of 64 mothers, 64%, improved reliably. Crossing the cut-off of 10 was the second test: 38 of 64, 59%, scored below 10 at rescreening. Mothers who met both tests, a reliable change that ended below the cut-off, numbered 34, or 53%.

Connection to Care

For a screening program, the most important clinical result may be what happens after a positive screen. A screen that finds a mother with depression and leads nowhere adds anxiety without help. Of the 118 mothers who screened positive, 81 had a warm handoff to the behavioral health clinician at the same visit, and 88 were connected to care of some kind, including the practice's clinician, their own obstetric or primary care clinician or a community program, within 30 days. That 75% connection rate is the project's most direct evidence of benefit, because collaborative models that link screening with managed follow-up have been shown in a large review of randomized trials to improve depression outcomes in adults compared with usual care (Archer et al., 2012).

Safety

Nine mothers, fewer than one in a hundred screened, answered the scale's item on self-harm with any score above zero. All nine were assessed by the behavioral health clinician or the pediatric clinician the same day under the practice's safety protocol. Two were referred for urgent psychiatric evaluation, and the others received safety planning and follow-up. These nine are a small number statistically but a large one clinically: before the project, the practice had no routine way of learning that a mother of an infant in the waiting room was thinking of harming herself.

What It Means for Infants

The screening was of mothers, but the setting was the infant's visit, and the infant is part of the clinical meaning. Untreated postpartum depression is associated with difficulties in feeding, sleep routines and the early relationship between mother and baby, which is why the national pediatric recommendation places screening in the well-child visit (Earls et al., 2019). The project did not measure infant outcomes, so it cannot claim benefits for the babies. What it can say is that for the 88 mothers connected to care, the pediatric practice acted on a risk to the family that it had previously left unexamined, and that the clinician seeing the infant now knows when the mother is struggling.

Why the Threshold Matters

The screening threshold shapes what clinical significance means. A meta-analysis of individual participant data reported that scores of 10 and above on the scale gave sensitivity near 0.85 and specificity near 0.84 against semi-structured interviews, and that 11 or higher maximized the two combined (Levis et al., 2020). The project used 10, accepting more false positives for fewer missed mothers. Clinically, that means some of the 118 positive screens were mothers without major depression who nonetheless benefited from a conversation about sleep, support and mood, and some of the improvement at rescreening reflects mothers who were never depressed moving further below the line.

Limits on Every Claim

The 64 rescreened mothers were those who returned for the next visit and completed the scale again, and they may have been doing better than those who did not. Scores also tend to fall over the postpartum months without intervention, and the project had no comparison group. The findings on individual change therefore describe a favorable subgroup and cannot be credited to the program alone. The findings on connection to care and safety are less affected, because they describe every positive screen.

Conclusion

Statistically, symptom scores fell sharply among rescreened mothers. Clinically, just over half of them showed change that was both reliable and brought them below the screening threshold, three in four positive-screening mothers were connected to care within a month, and nine mothers at risk of self-harm were identified and assessed the same day. The last two findings, which cover every positive screen, are the strongest evidence that the program matters.

Both deserve emphasis at the defense.

References

Archer, J., Bower, P., Gilbody, S., Lovell, K., Richards, D., Gask, L., Dickens, C., & Coventry, P. (2012). Collaborative care for depression and anxiety problems. Cochrane Database of Systematic Reviews, 2012(10), Article CD006525. https://doi.org/10.1002/14651858.CD006525.pub2

Cox, J. L., Holden, J. M., & Sagovsky, R. (1987). Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. British Journal of Psychiatry, 150(6), 782-786. https://doi.org/10.1192/bjp.150.6.782

Earls, M. F., Yogman, M. W., Mattson, G., Rafferty, J., & Committee on Psychosocial Aspects of Child and Family Health. (2019). Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics, 143(1), Article e20183259. https://doi.org/10.1542/peds.2018-3259

Jacobson, N. S., & Truax, P. (1991). Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology, 59(1), 12-19. https://doi.org/10.1037/0022-006X.59.1.12

Levis, B., Negeri, Z., Sun, Y., Benedetti, A., & Thombs, B. D. (2020). Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: Systematic review and meta-analysis of individual participant data. BMJ, 371, Article m4022. https://doi.org/10.1136/bmj.m4022