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.
COMPLETED
NA
318 participants
Past 6 months
2025-02-05
Participant Flow
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
| 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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
Wait List Control: Tiwahe Wicaghwicayapi
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place