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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05129501
Enrollment
318
Registered
2021-11-22
Start date
2021-10-09
Completion date
2022-10-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Domestic Violence

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.

Interventions

BEHAVIORALExperimental

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.

Sponsors

Bennington College
CollaboratorUNKNOWN
Centers for Disease Control and Prevention
CollaboratorFED
University of Nebraska Lincoln
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse Childhood Experiences-Child ReportedPast 6 monthsComprehensive 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.
Conflict Tactics Scale-Adult ReportedPast 6 monthsIntimate 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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 Experimental: 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.
173
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
145
Total318

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up5441

Baseline characteristics

CharacteristicWait List Control: Tiwahe WicaghwicayapiTotalTreatment: Tiwahe Wicaghwicayapi
Age, Continuous23.01 years
STANDARD_DEVIATION 15.71
22.55 years
STANDARD_DEVIATION 15.16
22.09 years
STANDARD_DEVIATION 14.76
Race (NIH/OMB)
American Indian or Alaska Native
119 Participants266 Participants147 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants7 Participants6 Participants
Race (NIH/OMB)
More than one race
17 Participants30 Participants13 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants5 Participants5 Participants
Race (NIH/OMB)
White
7 Participants8 Participants1 Participants
Region of Enrollment
United States
145 participants318 participants173 participants
Sex/Gender, Customized
Man/Boy
45 Participants106 Participants61 Participants
Sex/Gender, Customized
Missing
1 Participants2 Participants1 Participants
Sex/Gender, Customized
Other (e.g., Two Spirit)
7 Participants14 Participants7 Participants
Sex/Gender, Customized
Woman/Girl
92 Participants196 Participants104 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1740 / 144
other
Total, other adverse events
0 / 1740 / 144
serious
Total, serious adverse events
0 / 1740 / 144

Outcome results

Primary

Adverse Childhood Experiences-Child Reported

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.

Time frame: Past 6 months

Population: This outcome measure is child-reported only.

ArmMeasureValue (MEAN)Dispersion
Treatment: Tiwahe WicaghwicayapiAdverse Childhood Experiences-Child Reported2.48 Mean number of adverse experiencesStandard Deviation 2.94
Wait List Control: Tiwahe WicaghwicayapiAdverse Childhood Experiences-Child Reported3.80 Mean number of adverse experiencesStandard Deviation 3.56
Primary

Conflict Tactics Scale-Adult Reported

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.

Time frame: Past 6 months

Population: This outcome measure is adult-reported only.

ArmMeasureValue (MEAN)Dispersion
Treatment: Tiwahe WicaghwicayapiConflict Tactics Scale-Adult Reported3.20 mean number of IPV experiencesStandard Deviation 5.1
Wait List Control: Tiwahe WicaghwicayapiConflict Tactics Scale-Adult Reported2.21 mean number of IPV experiencesStandard Deviation 3.92

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026