The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children

February 3, 2025 updated by: University of Nebraska Lincoln

The Impact of an Adapted Version of the Strengthening Families Program on Reducing IPV Among Caregivers and ACEs Among Their Children (RCS Update)

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Rapid City Family Project Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment: Tiwahe Wicaghwicayapi

Part 1: Conduct informed consent process, perform baseline assessments (time 1 survey) Part 2: Complete the program over 7 weeks, fidelity checking during program Part 3: Takes survey immediately after program (time 2 survey) Part 4: Time 3 survey six months after Time 2 survey.

Note: Participants are "randomized at the family level" into one of two arms (treatment or control), and children are assigned to the same arm as their caregiver.

The Tiwahe Wicagwicayapi seven-session program is for children ages 10 to 14 who are Native American and/or living in poverty and their caregivers. The program begins with a traditional Lakota meal followed by family time and break-out time for caregivers only and children only. The program includes skill-building activities as well as the integration of Lakota language, history, and culture. The program is facilitated by diverse individuals, predominantly Native Americans in Rapid City and surrounding tribal communities.
No Intervention: Wait List Control: Tiwahe Wicaghwicayapi

Part 1: Conduct informed consent process, perform baseline assessments (time 1 survey) Part 2: Waitlist with access to resources while treatment group completes program Part 3: Takes survey immediately after experimental group completes program (time 2 survey) Part 4: Time 3 survey six months after Time 2 survey

*Complete program.

Note: Participants are "randomized at the family level" into one of two arms (treatment or control), and children are assigned to the same arm as their caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Childhood Experiences-Child Reported
Time Frame: Past 6 months
Comprehensive ACEs Measure (Higher scores indicate higher adverse childhood experiences). Note: As explained in the Pre-Assignment Details, participants were "randomized at the family level" into one of two arms (treatment or control), and children were assigned to the same arm as their caregiver. Additionally, some measures were collected only for the children or only for the caregivers. This particular measure was collected for children only.
Past 6 months
Conflict Tactics Scale-Adult Reported
Time Frame: Past 6 months
Intimate Partner Violence (Higher scores indicate higher levels of intimate partner violence victimization). Note: As explained in the Pre-Assignment Details, participants were "randomized at the family level" into one of two arms (treatment or control), and children were assigned to the same arm as their caregiver. Additionally, some measures were collected only for the children or only for the caregivers. This particular measure was collected for adults (i.e., caregivers) only.
Past 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Cohesion
Time Frame: Past 6 months
Family Adaptability and Cohesion Evaluation Scales II (Min:1, Max:5; Higher scores indicate more cohesion).
Past 6 months
Parental Monitoring
Time Frame: Past 6 months
Nine items adapted from Small & Kerns (1993). (Min:1, Max:5; Higher scores indicate more monitoring).
Past 6 months
Emotion Regulation
Time Frame: Past 6 months
Difficulties in Emotion Regulation Scale Short Form (Min:1, Max:5; Higher scores indicate less regulation)
Past 6 months
Connection to Lakota/Nakota/Dakota Culture
Time Frame: Past 6 months
Author created with community input (Min: 0, Max: 3; Higher scores indicate greater connection to Lakota/Nakota/Dakota culture)
Past 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katie M Edwards, PhD, University of Nebraska Lincoln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kumpfer, K. L. (1998). Prevention Interventions: The Strengthening Families Program. Drug Abuse Prevention Through Family Interventions, 160-207.
  • 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.
  • 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.
  • 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 21287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This data will not be shared publicly due to the sensitive nature and history of data being used to oppress Indigenous groups. The Data Safety Monitoring Board and IRB has have the right to see deidentified data. Any publicly disseminated findings will be approved by the Native Advisory Board and surrounding tribal communities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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