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| Name | Class |
|---|---|
| Bennington College | UNKNOWN |
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: Tiwahe Wicaghwicayapi | Experimental | 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. |
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| Wait List Control: Tiwahe Wicaghwicayapi | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Past 6 months |
| 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. | Past 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie M Edwards, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rapid City Family Project Office | Rapid City | South Dakota | 57702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kumpfer, K. L. (1998). Prevention Interventions: The Strengthening Families Program. Drug Abuse Prevention Through Family Interventions, 160-207. | ||
| 41522882 | Result | Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23. | |
| Result | 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. | ||
| Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Participants were "randomized at the family" level into one of two arms (treatment or control). Randomized at the family level means that the caregiver was randomized into an arm, and then the rest of the family (that is, their children aged 10-14) were automatically assigned into that same study arm. Thus, caregivers and their children were always in the same arm (because it was a family intervention, the design demanded that the entire family be in the same study arm). 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. |
| FG001 | 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 were "randomized at the family level" into one of two arms (treatment or control). Randomized at the family level means that the caregiver was randomized into an arm, and then the rest of the family (that is, their children aged 10-14) were automatically assigned into that same study arm. Thus, caregivers and their children were always in the same arm (because it was a family intervention, the design demanded that the entire family be in the same study arm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Number of participants, including both caregivers and children (all measures in this chart include both children and caregivers).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This outcome measure is child-reported only. | Posted | Mean | Standard Deviation | Mean number of adverse experiences | Past 6 months |
|
through study completion; that is, from baseline to six month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie M Edwards, PhD | University of Nebraska-Lincoln, Nebraska Center for Research on Children, Youth, Families, and Schools/Interpersonal Violence Research Laboratory | 402-472-2448 | katie.edwards@unl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2023 | May 15, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2021 | May 15, 2024 | SAP_002.pdf |
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|
| Result | 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. |
| 41641935 | Derived | Waterman EA, Wheeler L, Edwards KM, Herrington R, Mullet N, Hopfauf S. Measures to Assess Efficacy of Family-Based Programs for Indigenous Populations: Adaptation, Psychometric Properties, and Congruence. Fam Process. 2026 Mar;65(1):e70118. doi: 10.1111/famp.70118. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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 |
|
|
| 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. | This outcome measure is adult-reported only. | Posted | Mean | Standard Deviation | mean number of IPV experiences | Past 6 months |
|
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|
| 0 |
| 174 |
| 0 |
| 174 |
| 0 |
| 174 |
| EG001 | 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 | 0 | 144 | 0 | 144 | 0 | 144 |
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