Clinical trial NCT05129501: The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children
Official title: The Impact of an Adapted Version of the Strengthening Families Program on Reducing IPV Among Caregivers and ACEs Among Their Children (RCS Update)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Childhood Experiences
Domestic Violence
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: Bennington College
name: Centers for Disease Control and Prevention
First posted: 2021-11-22
Enrollment: 318
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adverse childhood experiences (ACEs) are unfortunately common and the known outcomes are concerning. However, very little is currently known about programs that may prevent ACEs among children, such as witnessing intimate partner violence (IPV) experienced by their caregivers. The purpose of this project is to adapt an existing evidence-based program (i.e., Strengthening Families) to prevent ACEs. A randomized control will be used to determine the initial efficacy of the program. The Strengthening Families program has demonstrated effectiveness in reducing substance use and initiation among youth, and some preliminary evidence suggests that it may be effective at reducing child maltreatment as well. Further, the Strengthening Families program promotes family bonding and cohesion, which are protective factors against ACEs. The Strengthening Families program has been adapted by researchers at UNL (Devan Crawford and Les Whitbeck) for Native American Families (i.e., BII-ZIN-DA-DE-DAH \[Listening to One Another\]) to prevent substance abuse. Using the Strengthening Families and BII-ZIN-DA-DE-DAH programs, the investigators seek to adapt these programs to prevent ACEs among youth ages 10-14 and their caregivers. The program adaptations are being led by a Community Advisory Board as well as community practitioner partners. The community has named the program Tiwahe Wicaghwicayapi (Lakota for: to strengthen/improve families). Native children and/or children living in poverty, ages 10 to 14, will participate in the program with their families. Participants will be "randomized at the family level" into one of two arms (treatment or control), and children were assigned to the same arm as their caregiver. Half of the families will go first and then the second half of the families will get the program after the last survey. The investigators will use surveys to see if and how the program is working and also interview some people who go through the program. A community Advisory Board is involved in all stages of this project and have the ultimate say about how data are shared.

Detailed description: Research documents the concerning rates and negative outcomes of adverse childhood experiences (ACEs). ACEs include child abuse as well as indicators of household (e.g., exposure to intimate partner violence \[IPV\]) and neighborhood (e.g., community violence) dysfunction. To date, little is known about two-generation programs that may simultaneously prevent ACEs among children, including IPV in their caregivers. The purpose of the proposed project is to test the impact of a widely researched alcohol and drug abuse prevention program, the Strengthening Families Program (SFP), on reducing IPV among caregivers, child abuse, and other ACEs among their children (ages 10 to 14). The SFP is for both caregivers and children and consists of parenting skills, children's life skills, and family skills courses taught together in seven 2-hour group sessions preceded by a meal that includes informal family practice time and group leader coaching. Guided by social learning and ecological theories that emphasize the importance of the proximal family environment, the members of this multistakeholder collaborative believe that the SFP has the strong potential to be effective in reducing IPV in caregivers and additional ACEs in their children (e.g., child abuse) given that the SFP focuses on reducing myriad risk and protective factors for not only drug use but also for ACEs, including IPV.

To bolster the program's effectiveness, the investigators will adapt the SFP (the adapted program will be called Tiwahe Wicaghwicayapi, Lakota for "to strengthen/improve families") to be culturally relevant given the large presence of American Indians in Rapid City, SD, where the project will take place; and to have utility for a broader, diverse audience. Notably, service providers in racially diverse communities frequently do not have the resources to implement various prevention programs. Thus, there is a need in many communities for ACEs prevention programming that is culturally grounded and generalizable to the broader community. The investigators will further enhance the Tiwahe Wicaghwicayapi program to include additional evidence-based IPV prevention strategies (e.g., economic empowerment) for adults and peer-to-peer violence prevention strategies (e.g., bystander intervention) for youth.

Outcome and Process Evaluation Aim: To gather efficacy data of the Tiwahe Wicaghwicayapi program using a randomized control trial in which eligible families will be randomly assigned to the treatment condition or a wait-list control condition, using pre-, immediate post- and 6-month post- follow-up surveys to test for reductions in ACEs (e.g., child abuse) in youth ages 10 to 14 and reductions in IPV in caregivers for individuals in the treatment group compared to the wait-list control group. Participants will be "randomized at the family level" into one of two arms (treatment or control), and children are assigned to the same arm as their caregiver. Additionally, some outcome measures are collected only for the children or only for the caregivers.

Eligibility criteria: Inclusion Criteria:

* Youth must be aged 10 to 14
* Must identify as a Native American, American Indian, Indigenous, and/or Lakota/Nakota/Dakota youth AND/OR live in poverty
* For caregivers, the inclusion criteria is that they must be a primary caregiver (e.g., parent, grandparent, etc) of a youth that meets criteria
* Both the youth and the caregiver(s) must be present to participate

Exclusion Criteria:

* Youth younger than 10 or older than 14
* Not identifying as Native American, American Indian, indigenous, and/or Lakota/Nakota/Dakota youth OR living in poverty
* Not being a primary caregiver of a youth that meets criteria
* Not having both the caregiver and youth present

Primary outcomes:
measure: Adverse Childhood Experiences-Child Reported
timeFrame: Past 6 months
measure: Conflict Tactics Scale-Adult Reported
timeFrame: Past 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rapid City
country: United States
facility: Rapid City Family Project Office
state: South Dakota
Study officials:
affiliation: University of Nebraska Lincoln
name: Katie M Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumpfer, K. L. (1998). Prevention Interventions: The Strengthening Families Program. Drug Abuse Prevention Through Family Interventions, 160-207.
citation: Kaufman, E. A., Xia, M., Fosco, G., Yaptangco, M., Skidmore, C. R., & Crowell, S. E. (2016). The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment, 38(3), 443-455.
citation: Olson, D. H., Portner, J., & Bell R. Q. (1982). FACES II: Family adaptability and cohesion evaluation scales. Family Social Science, University of Minnesota, St. Paul, Minnesota.
citation: Small, S. A., & Kerns, D. (1993). Unwanted sexual activity among peers during early and middle adolescence: Incidence and risk factors. Journal of Marriage and the Family, 941-952.
citation: Straus, M. A., Hamby, S. L., Boney-McCoy, S., & Sugarman, D. B. (1996). The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of family issues, 17(3), 283-316.