Abstract
The purpose of this research was to assess the impact of an educational intervention on paternal knowledge, attitudes, and support about newborn screening (NBS) and dried blood spots (DBS). Participants (n = 147) were randomized into one of two groups. The results from this study indicated that video education tools about NBS and DBS is associated with significantly increased knowledge, support, and satisfaction for both NBS and research use of DBS and an opt-out consent approach for DBS among fathers.
Introduction
While newborn screening is mandatory in most states, the retention and use of residual dried blood spots (DBS) is not. Residual DBS are a unique opportunity for public health research because it incorporates biospecimens from almost all children born in the USA. Allowing a child’s residual DBS to be stored and used for research purposes ideally should reflect a joint decision by the parents. Although only one parental signature is legally required for permission to store and use the residual newborn screening samples, it is appropriate and desirable for parents to communicate with one another about this decision. As such, how fathers are integrated into the education and consent process is important not only for health departments but for this research resource.
We conducted a randomized control trial (RCT) to assess the impact of new prenatal education approach among pregnant women about newborn screening and the storage and use of leftover newborn screening blood samples (Botkin et al. 2016). The study results found that education during pregnancy was associated with significantly higher scores on knowledge about NBS and residual DBS use and willingness and support for research with residual DBS. This RCT only surveyed fathers for the same outcomes under the assumption that education for mothers on the topic may lead to changes in knowledge or attitudes in their partners. Our survey results for fathers found little to no difference between the control and intervention groups, indicating that an intervention targeted to the mother does not directly translate into improved knowledge for the father (Botkin et al. 2016). Therefore, the purpose of this study aimed to investigate if an educational video intervention specifically targeting fathers about newborn screening and the storage and use of newborn screening samples would result in increased knowledge, increased support, and a change in attitudes toward newborn screening and DBS retention and research use compared to written information typically provided in brochures.
Methods
Institutional review board approval was obtained prior to any research activity. During August 2016, 147 participants were recruited through Knowledge Networks (KN), a company that conducts Internet-based surveys using a large, pre-established panel with a nationally representative probability sample (Couper 2000). Simple randomization was used, resulting in 58 in the intervention group and 89 in the control group (see Table 1 for demographics of this sample and the original RCT).
Table 1.
Demographics
| Demographics table | ||||
|---|---|---|---|---|
| Fathers | NBS prenatal RCT | |||
| n = 147 | n = 664 | |||
| Characteristic | Avg. or n | SD or % | Avg. or n | SD or % |
| Age at enrollment (years) | 37.78 | 7.17 | 31.05 | 5.60 |
| Hispanic | ||||
| Yes | 12 | 8.2% | 184 | 27.9% |
| No | 135 | 91.8% | 475 | 72.1% |
| Race | ||||
| Black or African American | 6 | 4.1% | 112 | 17.0% |
| White | 120 | 81.6% | 321 | 48.6% |
| Multi-racial | 1 | 0.7% | 39 | 5.9% |
| Other | 20 | 13.6% | 157 | 23.6% |
| Unknown or not reported | 0 | 0.0% | 35 | 5.3% |
| Education | ||||
| Less than high school | 1 | 0.68% | 47 | 7.1% |
| High school | 14 | 9.52% | 107 | 16.1% |
| Some college | 32 | 21.77% | 190 | 28.6% |
| Bachelor’s degree or higher | 100 | 68.03% | 319 | 48.0% |
| Unknown or not reported | 0 | 0.0% | 1 | 1.5% |
| Income | ||||
| Under $24,999 | 16 | 10.9% | 109 | 16.4% |
| $25,000–$50,000 | 24 | 16.3% | 113 | 17.0% |
| $50,001–$100,000 | 62 | 42.2% | 146 | 22.0% |
| $100,001–$150,000 | 26 | 17.7% | 76 | 11.4% |
| Over $150,000 | 19 | 12.9% | 74 | 11.1% |
| Not sure/do not know | 0 | 0.0% | 103 | 15.5% |
| Decline to answer | 0 | 0.0% | 43 | 6.5% |
The intervention group watched two brief educational videos developed by the Genetic Science Learning Center (GSLC) at the University of Utah. A 6-min video conveyed information about NBS, based on the work of Davis et al. (Davis et al. 2006). A separate 7-min video, developed based on our prior research, conveyed basic information about residual DBS and their potential uses in biomedical research (Botkin et al. 2014). The control group was provided brief written information about NBS, similar to what would be provided in the brochure at the hospital. Immediately after watching the videos or reading the educational material, all participants completed the follow-up measures.
Measures
Two knowledge measures and questions about attitudes and satisfaction were used from the original RCT (see Botkin et al. 2016). The knowledge scale consisted of 15 items assessing comprehension about newborn screening (alpha = .78) and 20 items measuring comprehension about the storage and research uses of leftover bloodspots (alpha = .95). Additional survey items from the original RCT were also used to assess support for research with DBS and satisfaction with the process.
Analysis
All analyses were conducted utilizing SPSS Version 22. Univariate analysis of variance with Tukey post-hoc adjustment was conducted to test the relationship of group assignment (control, and video groups) on knowledge outcome scores. Pearson Chi-square or Fisher’s exact testing (if cell count minimums were violated) were used to test group assignment with categorical outcome variables (i.e., opting out of NBS, attitude, and opinion questions).
Results
The total correct responses on our knowledge instrument regarding NBS increased from 50.6% in the control group to 74.7% in the video intervention group (p < 0.001) and for knowledge instrument regarding DBS the total correct responses increased from 23.2% in the control group to 75.4% for the video intervention group (p < 0.001). Also, support for research with DBS on diseases that affect women and children was significantly higher for the video intervention group (p = 0.042) and for quality improvement for newborn screening (p < 0.001). Satisfaction with information provided was also significantly higher for the video intervention group (p > 0.001). Finally, participants were asked if they prefer an opt-in or an opt-out consent approach. There was over representation of answering “Use the leftover blood spots only if parents sign a form saying it is OK” in the control group (68.5%) compared to the intervention group (50.0%), and over representation of answering “Use the leftover blood spots unless the parents contact the health department to remove their child’s bloodspot” in the video group (48.3%) compared to control group (31.5%) (p = 0.047).
Discussion
The results from this study as well as our previous RCT among pregnant women (Botkin et al. 2016), indicated that video education tools about NBS and DBS delivered at the same time is associated with increased knowledge, support, and satisfaction for both NBS and research use of DBS compared to brochure-based information approaches. When the fathers were surveyed in the original RCT (Botkin et al. 2016), there was little to no difference between the control group and the video intervention group on measures of knowledge, satisfaction, and attitudes toward NBS and DBS. As such, interventions that are related to children may want to target fathers as well as mothers, together or separately, and not to assume education of one parent translates to the other parent.
Finally, as noted in other research and this study, when educated about both NBS and DBS, there was significantly more support for an opt-out approach to the consent for the storage and use of DBS and can increase trust (Rothwell et al. 2016).
Acknowledgements
This research was funded by the National Institutes of Health (NIH), grant HD062762
Compliance with ethical standards
Funding
This study was funded by the National Institutes of Health (NIH), grant HD062762.
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
References
- Botkin, J. R., Rothwell, E., Anderson, R. A., Goldenberg, A., Kuppermann, M., Dolan, S. M., … Stark, L. (2014) What parents should know about the storage and use of residual newborn bloodspots. Am J Med Gene 164A (11): 2739–2744 [DOI] [PMC free article] [PubMed]
- Botkin, J. R., Rothwell, E., Anderson, R. A., Rose, N., Dolan, S. M., Kuppermann, M., … Wong, B. (2016) Prenatal education of parents about newborn screening and residual dried bloodspots. JAMA Pediatr 170(6): 543–549 [DOI] [PMC free article] [PubMed]
- Couper M. Web surveys: a review of issues and approaches. Public Opinion Quarterly. 2000;64(4):464–494. doi: 10.1086/318641. [DOI] [PubMed] [Google Scholar]
- Davis, T. C., Humiston, S. G., Arnold, C. L., Bocchini, J., Bass, P. F., Kennen, E. M., … Lloyd-Puryear, M. (2006) Recommendations for effective newborn screening communication: Results of focus groups with parents, providers, and experts. Pediatrics 117: 326–340. doi: 10.1542/peds.2005-2633M [DOI] [PubMed]
- Rothwell E, Wong B, Anderson RA, Botkin JR. The influence of education on public trust and consent preferences with residual newborn screening dried blood spots. Journal of Empirical Research on Human Research Ethics. 2016;11:231–236. doi: 10.1177/1556264616656976. [DOI] [PMC free article] [PubMed] [Google Scholar]