NCT05129501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

October 7, 2021

Results QC Date

December 2, 2023

Last Update Submit

February 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

Behavioral: Experimental

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.

Interventions

ExperimentalBEHAVIORAL

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.

Treatment: Tiwahe Wicaghwicayapi

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Both the youth and the caregiver(s) must be present to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rapid City Family Project Office

Rapid City, South Dakota, 57702, United States

Location

Related Publications (5)

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

    BACKGROUND
  • 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.

    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.

    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.

    RESULT

Results Point of Contact

Title
Katie M Edwards, PhD
Organization
University of Nebraska-Lincoln, Nebraska Center for Research on Children, Youth, Families, and Schools/Interpersonal Violence Research Laboratory

Study Officials

  • Katie M Edwards, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 22, 2021

Study Start

October 9, 2021

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

February 5, 2025

Results First Posted

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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.

Locations