Trial Outcomes & Findings for The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children (NCT NCT05129501)

NCT ID: NCT05129501

Last Updated: 2025-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

318 participants

Primary outcome timeframe

Past 6 months

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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).
Overall Study
STARTED
173
145
Overall Study
Additional Information: Number of Children Enrolled
107
87
Overall Study
Additional Information: Number of Caregivers Enrolled
66
58
Overall Study
COMPLETED
119
104
Overall Study
NOT COMPLETED
54
41

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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).
Overall Study
Lost to Follow-up
54
41

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment: Tiwahe Wicaghwicayapi
n=173 Participants
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.
Wait List Control: Tiwahe Wicaghwicayapi
n=145 Participants
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
Total
n=318 Participants
Total of all reporting groups
Age, Continuous
22.09 years
STANDARD_DEVIATION 14.76 • n=99 Participants
23.01 years
STANDARD_DEVIATION 15.71 • n=107 Participants
22.55 years
STANDARD_DEVIATION 15.16 • n=206 Participants
Sex/Gender, Customized
Man/Boy
61 Participants
n=99 Participants
45 Participants
n=107 Participants
106 Participants
n=206 Participants
Sex/Gender, Customized
Woman/Girl
104 Participants
n=99 Participants
92 Participants
n=107 Participants
196 Participants
n=206 Participants
Sex/Gender, Customized
Other (e.g., Two Spirit)
7 Participants
n=99 Participants
7 Participants
n=107 Participants
14 Participants
n=206 Participants
Sex/Gender, Customized
Missing
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
147 Participants
n=99 Participants
119 Participants
n=107 Participants
266 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=99 Participants
1 Participants
n=107 Participants
7 Participants
n=206 Participants
Race (NIH/OMB)
White
1 Participants
n=99 Participants
7 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
13 Participants
n=99 Participants
17 Participants
n=107 Participants
30 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=99 Participants
0 Participants
n=107 Participants
5 Participants
n=206 Participants
Region of Enrollment
United States
173 participants
n=99 Participants
145 participants
n=107 Participants
318 participants
n=206 Participants

PRIMARY outcome

Timeframe: Past 6 months

Population: This outcome measure is child-reported only.

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.

Outcome measures

Outcome measures
Measure
Treatment: Tiwahe Wicaghwicayapi
n=107 Participants
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.
Wait List Control: Tiwahe Wicaghwicayapi
n=87 Participants
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
Adverse Childhood Experiences-Child Reported
2.48 Mean number of adverse experiences
Standard Deviation 2.94
3.80 Mean number of adverse experiences
Standard Deviation 3.56

PRIMARY outcome

Timeframe: Past 6 months

Population: This outcome measure is adult-reported only.

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.

Outcome measures

Outcome measures
Measure
Treatment: Tiwahe Wicaghwicayapi
n=66 Participants
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.
Wait List Control: Tiwahe Wicaghwicayapi
n=58 Participants
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
Conflict Tactics Scale-Adult Reported
3.20 mean number of IPV experiences
Standard Deviation 5.10
2.21 mean number of IPV experiences
Standard Deviation 3.92

Adverse Events

Treatment: Tiwahe Wicaghwicayapi

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait List Control: Tiwahe Wicaghwicayapi

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katie M Edwards, PhD

University of Nebraska-Lincoln, Nebraska Center for Research on Children, Youth, Families, and Schools/Interpersonal Violence Research Laboratory

Phone: 402-472-2448

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place