Trial Outcomes & Findings for Implementation of Adverse Childhood Experiences (ACEs) Policy (NCT NCT04916587)
NCT ID: NCT04916587
Last Updated: 2025-07-20
Results Overview
The number of participants with ACEs screenings.
COMPLETED
NA
7645 participants
Every 10 weeks during the study trial, up to 19 months
2025-07-20
Participant Flow
Unit of analysis: Clinics
Participant milestones
| Measure |
Practice 1
This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule.
Clinic 1: Baseline/Control for 10 weeks, followed by six intervention periods of 60 weeks total.
|
Practice 2
This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule.
Clinic 2: Baseline/Control for 20 weeks, followed by intervention period of 50 weeks total.
|
Practice 3
This clinic was part of the study trial based on the seven extended 10-week periods in the Stepped Wedge schedule.
Clinic 3: Baseline/Control for 30 weeks, followed by intervention period of 40 weeks total.
|
Practice 4
This practice is a comparison group that did not receive the intervention throughout the study period.
|
Practice 5
This is a comparison group that did not received the intervention
|
|---|---|---|---|---|---|
|
Step 1: Months 1-2.3
STARTED
|
248 1
|
587 1
|
56 1
|
351 1
|
97 1
|
|
Step 1: Months 1-2.3
COMPLETED
|
248 1
|
587 1
|
56 1
|
351 1
|
97 1
|
|
Step 1: Months 1-2.3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 2: Months 2.3 - 4.6
STARTED
|
367 1
|
604 1
|
74 1
|
416 1
|
151 1
|
|
Step 2: Months 2.3 - 4.6
COMPLETED
|
367 1
|
604 1
|
74 1
|
416 1
|
151 1
|
|
Step 2: Months 2.3 - 4.6
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 3: Months 4.6 - 6.9
STARTED
|
312 1
|
470 1
|
88 1
|
322 1
|
13 1
|
|
Step 3: Months 4.6 - 6.9
COMPLETED
|
312 1
|
470 1
|
88 1
|
322 1
|
13 1
|
|
Step 3: Months 4.6 - 6.9
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 4: Months 6.9 - 9.2
STARTED
|
189 1
|
354 1
|
75 1
|
89 1
|
0 0
|
|
Step 4: Months 6.9 - 9.2
COMPLETED
|
189 1
|
354 1
|
75 1
|
89 1
|
0 0
|
|
Step 4: Months 6.9 - 9.2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 5: Months 9.2 - 11.5
STARTED
|
238 1
|
448 1
|
100 1
|
209 1
|
0 0
|
|
Step 5: Months 9.2 - 11.5
COMPLETED
|
238 1
|
448 1
|
100 1
|
209 1
|
0 0
|
|
Step 5: Months 9.2 - 11.5
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 6: Months 11.5 - 13.8
STARTED
|
260 1
|
465 1
|
97 1
|
104 1
|
0 0
|
|
Step 6: Months 11.5 - 13.8
COMPLETED
|
260 1
|
465 1
|
97 1
|
104 1
|
0 0
|
|
Step 6: Months 11.5 - 13.8
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 7: Months 13.8 - 16.1
STARTED
|
227 1
|
470 1
|
106 1
|
58 1
|
0 0
|
|
Step 7: Months 13.8 - 16.1
COMPLETED
|
227 1
|
470 1
|
106 1
|
58 1
|
0 0
|
|
Step 7: Months 13.8 - 16.1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of Adverse Childhood Experiences (ACEs) Policy
Baseline characteristics by cohort
| Measure |
Control
n=1657 Participants
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=4178 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
n=1810 Participants
Clinic starting ACEs screening without the implementation strategy
|
Total
n=7645 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1657 Participants
n=5 Participants
|
4178 Participants
n=7 Participants
|
1810 Participants
n=5 Participants
|
7645 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
788 Participants
n=5 Participants
|
2018 Participants
n=7 Participants
|
901 Participants
n=5 Participants
|
3707 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
869 Participants
n=5 Participants
|
2160 Participants
n=7 Participants
|
909 Participants
n=5 Participants
|
3938 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
774 Participants
n=5 Participants
|
1719 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
3211 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
820 Participants
n=5 Participants
|
2240 Participants
n=7 Participants
|
978 Participants
n=5 Participants
|
4038 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
774 Participants
n=5 Participants
|
1719 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
3211 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
63 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other / Unknown
|
820 Participants
n=5 Participants
|
2240 Participants
n=7 Participants
|
978 Participants
n=5 Participants
|
4038 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1657 participants
n=5 Participants
|
4178 participants
n=7 Participants
|
1810 participants
n=5 Participants
|
7645 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Every 10 weeks during the study trial, up to 19 monthsPopulation: Children ages 0 - 5 years old attending the annual check-up visit at the clinic
The number of participants with ACEs screenings.
Outcome measures
| Measure |
Control
n=1657 Participants
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=4178 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
n=1810 Participants
Clinic starting ACEs screening without the implementation strategy
|
|---|---|---|---|
|
ACEs Screenings Reach
|
0 Participants
|
468 Participants
|
73 Participants
|
PRIMARY outcome
Timeframe: Every 10 weeks during the study trial, up to 19 months.Population: Children ages 0 - 5 years old attending the annual check-up visit at the clinic
Number of participants with a mental health referral (behavioral analysis, behavioral health, care coordinator, care management, child development/development center or social work)
Outcome measures
| Measure |
Control
n=1657 Participants
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=4158 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
n=1810 Participants
Clinic starting ACEs screening without the implementation strategy
|
|---|---|---|---|
|
Mental Health Service Referral
|
6 Participants
|
302 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: First score measure during ACEs screenings. Follow-up scores from 8 - 16 monthsPopulation: The PSC data was collected for a subset of the total sample. A group of caregivers reported on PSC scores during ACEs screenings (n=414). From that group, a total of 50 caregivers were randomly selected for follow-up to assess PSC scores after the screenings (n=50)
The percentage of children screening positive for BPSS or PPSC from the time of the ACEs screening. These data were collected on a subsample of study participants during ACEs screenings (n=414). From that group, a total of 50 caregivers provided follow up information on PSC scores (n=50). This secondary outcome was collected as part of the strategy in the intervention group only (i.e., ACEs screenings plus the multifaceted implementation strategy group). The data were only collected from the "ACEs Screenings and a Multifaceted Implementation Strategy" Arm/Group.
Outcome measures
| Measure |
Control
n=414 Participants
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=50 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
Clinic starting ACEs screening without the implementation strategy
|
|---|---|---|---|
|
Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)
|
111 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: End of data collection -End of period 7 in the stepped-wedge schedulePopulation: Children ages 0 - 5 years old attending the annual check-up visit at the clinic
Self-reported 4-item instrument to evaluate acceptability of ACEs policy and implementation efforts. 5-pt Likert scale; average score of 4+ shows acceptability. Good internal consistency (α=0.83). Test-retest reliability r=0.83. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the acceptability of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate acceptability used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater acceptability.
Outcome measures
| Measure |
Control
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=10 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
Clinic starting ACEs screening without the implementation strategy
|
|---|---|---|---|
|
Acceptability of the Strategy
|
—
|
2.98 units on a scale
Standard Deviation 0.90
|
—
|
SECONDARY outcome
Timeframe: End of data collection- End of Period 7 based on the Stepped-Wedge SchedulePopulation: Children ages 0 - 5 years old attending the annual check-up visit at the clinic
Self-reported 4-item instrument to evaluate the feasibility of implementation efforts. 5-pt Likert scale; average score of 4+ shows ACEs policy and implementation strategy perceived as feasible. Good internal consistency (α=0.89). Test-retest reliability r=0.88. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the feasibility of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites. This self-reported 4-item instrument to evaluate feasibility used a 5-point Likert scale for each item, ranging from 1 (Completely Disagree) to 5 (Completely Agree). The total score is calculated by summing the responses across all four items, which range from 4 to 20, with higher scores indicating greater feasibility.
Outcome measures
| Measure |
Control
Clinics without implementing the strategy supporting ACEs screening.
|
Interventions
n=10 Participants
Clinics started the ACEs screening and the implementation strategy.
|
Comparison Clinics
Clinic starting ACEs screening without the implementation strategy
|
|---|---|---|---|
|
Feasibility of the Strategy
|
—
|
2.97 units on a scale
Standard Deviation 0.92
|
—
|
Adverse Events
Intervention Group: ACEs Screenings and a Multifaceted Implementation Strategy
Control Group: Standard Care
Comparison Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place