NCS-Cover Memo

National Institute of Health

National Institute of Child Health and Human Development

Developing Best Practices to Encourage Non-Residential Fathers’ Participation in the National Children’s Study: Perspectives from both Unwed, Non-Residential Mothers and Fathers

Request for OMB Clearance of Data Collection Instruments

under NIH/NICHD Generic Clearance # 0925-0590

NICHD Division: Program Office, National Children’s Study

Contact Name: Dr. Ken Schoendorf

Contact Phone: 301-594-1302

Contact Email: [email protected]

Title: Developing Best Practices to Encourage Non-Residential Fathers’ Participation in the National Children’s Study: Perspectives from both Unwed, Non-Residential Mothers and Fathers

Plan Control Number: 0925-0590

Program Title: Formative Research and Pilot Methodology Studies for the National Children’s Study

Program Goals: Studies performed under this program are designed to improve data collection within the National Children’s Study. Projects under this Generic Clearance will include projects designed to:

- improve Community Engagement at Study Locations, thus improving participant recruitment and retention

- inform methods of engaging Community-level health and medical providers, resulting in improved participant recruitment and retention

- test technologic methods of interaction with participants (e.g., Interactive Voice Recognition) to decrease respondent burden, improve participant satisfaction, and decrease cost

Purpose of the Survey: In many cases NCS infants will be conceived by, and born to, unwed mothers that do not cohabitate with the father of the baby. For example, in Philadelphia County in 2004, 28%, 30%, 73% and 78% of Asian, non-Hispanic white, Hispanic and African American infants, respectively, were born to unwed mothers. Although unwed mothers may ‘live as married’ with the father of the baby, the 2000 census indicated that in Philadelphia 35% of the children lived in female-headed households. The proportion of households headed by a female also varies by race/ethnicity with African American children demonstrating the highest risk.

The NCS protocol requires that women be enrolled, via door-to-door recruitment, if they are at high risk of pregnancy or in their first trimester of pregnancy. Therefore, by design, women are the gatekeepers of participation. When the potential participant is either married or living as married with the father of the baby, it is anticipated that participation in the NCS will be discussed within the family and that often, if the woman agrees to participate, the father will also agree to take part in the project. However, in many counties, especially urban settings, the above-described scenario is not the norm. Often women will not reside with the father of the baby and may even have a contentious relationship. In order for the NCS to collect the T1 paternal samples from nonresidential fathers, participating women will be our only source of contact information for the father.

Given the enormous percentage of nonresidential fathers in certain socio-demographic groups, best practices for negotiating participation in the NCS among unwed, nonresidential fathers must be developed. This study proposes to employ focus group methodologies to explore how best to facilitate participation of nonresidential fathers in the NCS. Specifically, 6 focus groups will be convened with pregnant or parenting women that do not live with the father of the baby to ascertain how best to convey the importance of father participation so that women will be likely to provide father contact information and/or facilitate his participation. Additionally, 6 focus groups will be conducted with nonresidential fathers of young children to develop best practices to describe the study and gain participation. In all likelihood, NCS staff will have to “cold-call” a proportion of these nonresidential fathers to describe the study and ask for participation. In this scenario it is critical to develop the best messaging to facilitate participation and dispel fears of ulterior motives.

Use of Results: Data from the focus groups will be analyzed by the research team using the long table approach described by Krueger and Casey (2000). Statements made by participants that are considered to be significant will be extracted and placed in categories. Data analysis continues by examining similarities and differences between statements. Related categories are then collapsed to create overall themes. A descriptive summary of each theme will be written and specific quotes extracted from participant statements as evidence. This process will be used for each of the three focus groups. Saturation of data occurs when there is no new information revealed in the final focus group. Follow–up phone interviews with focus group participants will be conducted with participants from each group if needed to clarify the themes that emerge.

The results of this study will be used to inform our development of local strategies and activities to enhance the willingness of non-residential mothers to facilitate NCS contact with the father of her baby and to create best practices for contacting, and enrolling, non-residential fathers.

Results from these focus groups will be presented for discussion and planning at Community Advisory Board meetings and on the Outreach and Engagement working group calls. Results will also be analyzed in aggregate for the purpose of drafting a manuscript to be submitted to a peer reviewed journal.

Target Respondents: Respondents will include two groups: fathers-to-be or fathers of children less than one year of age who currently do not reside with the mother (nonresidential fathers); and pregnant women in their third trimester or mothers of children less than one year of age who do not live with the child’s father. For this study, only English speaking men and women will be deemed eligible.

Survey Administration: The primary recruitment strategy for this study, used in previous studies, is a snowball sampling technique resulting in participation of a convenience sample. Community organizations, programs and businesses where low-income fathers are likely to frequent will be identified. For example, flyers may be distributed at local businesses such as barber shops, tobacco stores, local fast food restaurants and convenience stores.

To recruit mothers the same strategy will be used focused on hair and nail salons, WIC offices, and pharmacies/drug stores. Connections will be made with staff of local community centers and similar programs in each of the counties to ask for referral of eligible persons to the study. Recruitment will also include pregnant women from hospital-based Medicaid clinics.

Survey Design: Qualitative methods will be used to seek input from both groups (non-residential fathers and mothers) on a variety of perceived facilitators and barriers to father participation in the NCS. Information will be gathered using focus groups and follow-up interview methods (if necessary).

A primary facilitator experienced in focus group and face-to-face interviewing will conduct all focus groups. The facilitator will use a question guide to facilitate group discussion and to obtain in-depth information from participants. Several note takers will accompany the facilitator. Note takers will record speaker changes using de-identified codes. For example, each seat will be assigned a number and as the speakers change throughout the dialogue, this will be denoted with changing numeric codes. In addition, each focus group will be audio taped and transcribed using speaker change notes. If needed, follow-up interviews will also be conducted with some focus group participants by the primary facilitator and serve to obtain further clarification or details about focus group comments. In order to calculate participant contact hours for this proposal, we assume that a maximum of 20% of focus group participants will be re-contacted for a 20-minute interview.

Four focus groups will be conducted in each county for a total of 8 groups divided evenly between mothers and fathers. Each focus group will include 6 to 8 volunteer participants for a minimum of 24 male and 24 female participants. Focus groups will be limited to 1 1/2 hours and include an introduction to the NCS, and a statement about how important it is to understand the perspective of the participants and how their perspectives will be used as the study is planned. At the start of each focus group, participants will be asked to complete a short demographic survey. These data will be used to describe, in aggregate, the focus group participants. The majority of the 1 1/2 hours will include discussion in response to four to five questions and relevant probe questions. The questions will start from more general toward specific and will vary in their level of structure; from “what is your perspective on…” to “what would you say are the two most useful…” Questions have been written in basic, lay terms. In order to enhance the participants’ understanding of the study, we will have available pictures or real examples of some of the equipment that will be left in the home; we might demonstrate how the bio specimens will be collected; show a list of questions women would be asked, a timeline of the length of the study and the visit points, etc. A series of sample questions for participating mothers and participating fathers, similar in content and style, are included as Attachment C – Sample Questions for Focus Groups & Follow-up.

Limitations: This qualitative method has been criticized for its potential subjectivity and lack of precision. To counter this limitation, the study will follow rigorous data collection, analysis, and interpretation methodology, record detailed observation notes, and work with all study staff to interpret the focus group transcripts and develop themes. The validity and reliability of the focus group data may be influenced by the following: Not representing views of the larger population of non-documented residents. The possibility of conformance, censoring, conflict avoidance or other unintended outcomes of the group process will be addressed as part of the data analysis.

Data Collection Burden: Respondents will be expected to participate in a 1 1/2 hour focus group. Respondents may also be asked to participate in a 20-minute follow-up phone interview.

Type of Respondent	Number of Respondents	Frequency of Response	Average Time per Response	Annual Hour Burden
Focus Group Participants	64	1	1.5	96 hours
Follow-up Participants	13	1	0.33	4.3 hours
Total	77			100.3 hours

IRB Approval: The study has received an IRB exemption from the local Children’s Hospital of Philadelphia IRB, included as Attachment A – CHOP IRB Exemption Determination.

Privacy Act: To protect the confidentiality of the participant’s data, there will be a unique identifier assigned to each participant within each focus group. Individual participant comments recorded by the note taker during focus groups will be transcribed using the numeric code. Thus, participant comments will be totally de-identified on the transcripts. All focus group transcriptions will be filed separate from participant demographic forms and both data sets will be stored in locked file cabinets. Participant demographics will be reported in aggregate format only. At the time of the focus group the primary facilitator will distribute and review the participant consent form, included as Attachment B – Consent to Participate in a Research Study.

Sensitive Questions: The survey instruments do not contain sensitive questions.

Remuneration: A cash incentive of $40 will be provided to the focus group participants.

Attachments:

Attachment A - CHOP IRB Exempt Determination

Attachment B- Consent to Participate in a Research Study

Attachment C- Sample Questions for Focus Groups and Follow-up

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