The Impact of an Adapted Version of the Strengthening Families Program on Reducing IPV Among Caregivers and ACEs Among Their Children (RCS Update)
Phase: NA
Conditions: Adverse Childhood Experiences, Domestic Violence
Sponsor: University of Nebraska Lincoln

ClinicalTrials.gov Data Entry Cover Sheet  
 
Today's date: May 15, 2024  
Document date: November 15, 2023 
 
 
Protocol ID: 21287  
Clinical Trials.gov ID: NCT05129501 
Project Title: The Impact of an Adapted Version of the Strengthening Families Program on IPV 
Among Caregivers and ACEs Among Children 
Principal Investigator: Katie M. Edwards, PhD, University of Nebraska-Lincoln 
 
 

Recruitment and Retention Plan   
  
Careful efforts will be made to maximize participant enrollment and minimize attrition in the survey and 
programming portions of the project. As described in the Statistical Design and Power Analysis section of this 
proposal (referenced in C.14 of the Research Strategy), we will enroll a total of 320 families (160 per 
condition). Based on previous similar research, including the PI’s work, we anticipate that we will retain 75% of 
the sample at the 8-month follow-up for a final sample size of 120 families per condition (160 youth and 160 
caregivers per condition x 2 conditions for a grand N = 640 youth and caregivers across conditions at the 
pretest, and 480 across conditions at the 8-month follow-up).   
  
Recruitment  
We will recruit from multiple agencies/organizations/schools in Rapid City, including Youth and Family  
Services; Children’s Home Society; Department of Social Services; Rural America Initiative; Rapid City Area  
Schools; Working Against Violence, Inc.; Girls, Inc.; Rapid City Police Department; Pennington County Sheriff’s 
Office; and Ellsworth Air Force Base. (See enclosed letters of support from these partners.) These partnering 
agencies/organizations/schools will do the following as detailed in their letters of support: (1) post project 
information on their social media sites; (2) allow the project team to have a table at events hosted by the 
school/agency/organization; (3) send recruitment letters to families that are involved with or attend the 
school/agency/organization; (4) share information about the project with staff so that they can pass along 
information to the youth and families they serve; and/or (5) encourage families to personally invite other 
families to the project. We will follow the recommendations for recruitment suggested by the Iowa State 
University Extension (e.g., use positive language when describing the project, personalize invitations). In 
addition to these efforts we will also “boost” posts on social media to advertise the project, place an 
advertisement in the local newspaper with project information, saturate the community with fliers advertising 
the project, and attend numerous community events (e.g., Black Hills Pow Wow, Lakota Nation Invitational, 
Black Hills Pride). Dr. Edwards (PI) has used these recruitment methods in another federally funded study 
(5U01CE003168) in South Dakota (SD) with success (as evidenced by over 80% returned consent forms in 
schools, for example). Also, as part of this same study, Dr. Edwards (PI) was able to recruit more than 50 
adults (e.g., caregivers, teachers) to participate in interviews and/or focus groups within a 2-week period. We 
will also advertise the study in other ways as recommended by the Research and Practice Advisory Board 
(RPAB). In addition, we will offer informational sessions that incorporate culturally grounded “feeds” (dinners to 
be covered by Dr. Edwards’s discretionary funds), which our previous work suggests increases community 
buy-in and enrollment. Finally, like previous studies in SD, we will engage in “door knocking” on the north side 
of Rapid City where the vast majority of residents are low income and/or American Indian. Door-knocking 
includes identifying areas within a community that have a large proportion of the target population. Once 
identified, members who live within the targeted neighborhoods are recruited and trained to go door to door 
and explain the nature of the study to potential participants, assess eligibility, and enroll families that are 
interested and meet inclusion criteria. We have had great success using this method in previous studies, 
especially with American Indian communities.   
Participants will have multiple ways to enroll in the study. They will have the option of attending 
informational sessions in addition to enrolling by phone, email, an online portal on a project website, or in 
person at various locations across Rapid City (i.e., we will have a strong presence at community events, 
especially those targeting American Indians and/or low-income individuals). We will also offer to go to the 
homes of interested participants to enroll them in the study. Interested families will first be asked if they have at 
least one child between the ages of 10 and 14. Families will also be required to answer “YES” to one or more 
of the following questions: (1) Is your child American Indian/Alaska Native/Lakota?; (2) Does your family 
(including all people who work and contribute to the finances of the household) make less than $25,750 a year 
(for family of four)?. Additionally, at least one caregiver and one child must commit to both the research and 
programming components of the project to be eligible to participate.   
  
Retention  
Intense efforts will be made to retain participants. First, at all programming sessions, a culturally tailored 
meal (e.g., buffalo, fry bread) will be served (paid for by the PI’s discretionary funds). Second, we will provide 

families with a gift card for each session that they attend (a gift card will be given to each family member who 
attends). We will also call, text, and email participants of upcoming programming and survey sessions and 
include reminders on our project social media sites. At the baseline survey, we will collect detailed contact 
information as well as social media account information. We will use this information to directly contact 
participants who do not show for a program and/or survey session and are not responsive to our initial contact 
attempts. We will engage in monthly check-ins with participants in order to keep them engaged and more likely 
to complete follow-up surveys. During these check-ins we will determine if any contact information has 
changed. We will also maintain relationships with families by sending them branded goods (e.g., a University of 
Nebraska–Lincoln T-shirt for the child) and by sending birthday cards. We will also seek participants’ approval 
to locate them via Intelius in the event we are not able to locate them using the contact information provided. 
Intelius is a database that allows the user to enter an individual’s name and/or contact information to receive 
updates about new contact information (e.g., new address). We have used this in a previous, federally funded 
study (grant number 2016-SI-AX-0003) with women who have histories of criminal offending, victimization, and 
addiction to retain over 85% of the sample, and there have been no negative impacts of using this service on 
participants. Also, widespread community support for this project will likely help with retention. Finally, we 
recognize the transient nature of the American Indian population in Rapid City, SD. More specifically, some 
American Indian families in Rapid City, SD, spend some of their time on one of the nearby reservations. We will 
work with families to enroll them in the study when they anticipate being in Rapid City for the duration of the 
project. We will also provide options for families to complete the follow-up surveys remotely in addition to 
having research staff make occasional visits to the nearby reservations for follow-up survey procedures.