Trial Outcomes & Findings for Study to Understand Risk and Resilience Opportunity for Newborns After Delivery (NCT NCT04438161)
NCT ID: NCT04438161
Last Updated: 2026-06-15
Results Overview
Mean number of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
399 participants
Primary outcome timeframe
Not more than 18 months postpartum
Results posted on
2026-06-15
Participant Flow
Participants for the parent study were recruited from a large, urban obstetric unit shortly before or shortly after childbirth. Due to COVID recruitment was delayed and moved to phone zoom. Consent occurred in stages to reduce participant burden. Consent 1 (n=399) obtained electronic birth records and depression screen; Consent 2, a week or two later for full clinical screen (n=313); Consent 3 for RCT from full screen participants (313) in parent study-n=150 planned; 105 actual.
RCT participants were consented from all participants remaining in contact at Consent 2 (n=313) in the parent study stratified by low (\<3) and high (3+) number of birth record risks. Families were consented to the RCT on a rolling basis. 105 of the planned 150 consented to the RCT; 78 from high and 27 from low risk strata. Consented participants were randomly assigned from each strata with a 2:1 ratio to either PERCCS treatment or care as usual referral.
Participant milestones
| Measure |
Low Risk Control
Original study design anticipated higher numbers of low risk families in initial consent. But the risk level was higher in the overall sample so there were fewer families with low birth risk counts(\<3) in the overall pool. So instead of 250 low risk at Consent Stage One the number was 174. Consent III for RCT (target =150) was rolling and recruited from those participants completing the screeners after the Consent 2 stage stratified by high or low risk. 105 families total consented to the RCT. Consent for the RCT was delayed due to COVID and had to be closed because of the need to have enough time remaining to follow for 18 months postpartum. 27 were consented from the low risk condition.
Consented participants were assigned 2:1 (in triples). 9 of the 27 low risk families were assigned to the control condition.
|
High Risk Control
Original study design anticipated higher numbers of low risk families in initial consent. But the risk level was higher in the overall sample so there were more available in the high birth record risk(3+) category. So instead of 150 high risk at Consent stage one the number was 225. Consent III for RCT (target =150) was rolling and recruited from those participants completing the screeners after the Consent 2 stage stratified by high or low risk. Consent for the RCT was delayed due to COVID and had to be closed because of the need to have enough time remaining to follow for 18 months postpartum. 78 were consented from the high risk condition.
Consented participants were assigned 2:1 (in triples). 25 of the 78 high risk families were assigned to the control condition.
|
Low Risk Treatment
Original study design anticipated higher numbers of low risk families in initial consent. But the risk level was higher in the overall sample so there were fewer families with low birth risk counts(\<3) in the overall pool. So instead of 250 low risk at Consent stage one the number was 174. Consent III for RCT (target =150) was rolling and recruited from those participants completing the screeners after the Consent 2 stage stratified by high or low risk. Consent for the RCT was delayed due to COVID and had to be closed because of the need to have enough time remaining to follow for 18 months postpartum. 27 were consented from the low risk condition.
Consented participants were assigned 2:1 (in triples). 18 of the 27 low risk families were assigned to the treatment condition.
|
High Risk Treatment
Original study design anticipated higher numbers of low risk families in initial consent. But the risk level was higher in the overall sample so there were more available in the high birth record risk(3+) category.So instead of 150 high risk at Consent stage one the number was 225. Consent III for RCT (target =150) was rolling and recruited from those participants completing the screeners after the Consent 2 stage stratified by high or low risk. Consent for the RCT was delayed due to COVID and had to be closed because of the need to have enough time remaining to follow for 18 months postpartum. 78 were consented from the high risk condition.
Consented participants were assigned 2:1 (in triples). 53 of the 78 high risk families were assigned to the treatment condition.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
25
|
18
|
53
|
|
Overall Study
COMPLETED
|
7
|
23
|
15
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Understand Risk and Resilience Opportunity for Newborns After Delivery
Baseline characteristics by cohort
| Measure |
Low Risk Control
n=9 Participants
Low risk families had two or fewer birth record risks and assigned 2:1 to control with 9 in control.
|
High Risk Control
n=25 Participants
High risk families had three or more birth record risks and assigned 2:1 to control with 25 in control.
|
Low Risk Treatment
n=18 Participants
Low risk families had two or fewer birth record risks and assigned 2:1 to control with 18 in treatment group.
|
High Risk Treatment
n=53 Participants
High risk families had three or more birth record risks and assigned 2:1 to control with 53 in treatment group.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 5.8 • n=20 Participants
|
25.0 years
STANDARD_DEVIATION 6.2 • n=20 Participants
|
30.2 years
STANDARD_DEVIATION 4.7 • n=40 Participants
|
26.1 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.7 • n=9 Participants
|
|
Race/Ethnicity, Customized
Other Race and/or Hisp
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
53 Participants
n=5 Participants
|
105 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black not Hisp
|
7 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
43 Participants
n=5 Participants
|
85 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White not Hisp
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
53 Participants
n=5 Participants
|
105 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Not more than 18 months postpartumPopulation: Service use is only available for those with 18 month follow-up so the number analyzed is less for this outcome.
Mean number of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up.
Outcome measures
| Measure |
Low Risk Treatment
n=15 Participants
Low risk natural history study (n=27 overall)
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in "low risk" count families (n=18 in Treatment).
|
High Risk Control
n=46 Participants
High risk families in prospective longitudinal study of newborns (n=78 overall).
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=25 control)
Participants in this arm will be randomized to:
1. PERCCS (see attached figure and table for details)
2. Care as Usual
|
Low Risk Control
n=7 Participants
Low risk natural history study (n=27 overall)
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in "low risk" count families (n=9 in control).
|
High Risk Control
n=23 Participants
High risk families in prospective longitudinal study of newborns (n=78 overall).
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=25 in control)
Participants in this arm will be randomized to:
1. PERCCS (see attached figure and table for details)
2. Care as Usual
|
|---|---|---|---|---|
|
Service Utilization
|
5.1 count of services
Standard Deviation 3.2
|
5.4 count of services
Standard Deviation 5.4
|
7.3 count of services
Standard Deviation 7.6
|
5.0 count of services
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: Not more than 18 months postpartumPopulation: Data for child maltreatment rates was based on match to administrative data with consent and was not subject to attrition as was the other outcome.
Rate of official reports of child maltreatment, ascertained from records of the Missouri Department of Social Services at age 18 months. Child Maltreatment (number of cases of investigated or assessed child abuse and neglect) as measured by official state administrative records
Outcome measures
| Measure |
Low Risk Treatment
n=18 Participants
Low risk natural history study (n=27 overall)
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in "low risk" count families (n=18 in Treatment).
|
High Risk Control
n=53 Participants
High risk families in prospective longitudinal study of newborns (n=78 overall).
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=25 control)
Participants in this arm will be randomized to:
1. PERCCS (see attached figure and table for details)
2. Care as Usual
|
Low Risk Control
n=9 Participants
Low risk natural history study (n=27 overall)
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in "low risk" count families (n=9 in control).
|
High Risk Control
n=25 Participants
High risk families in prospective longitudinal study of newborns (n=78 overall).
\*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=25 in control)
Participants in this arm will be randomized to:
1. PERCCS (see attached figure and table for details)
2. Care as Usual
|
|---|---|---|---|---|
|
Child Maltreatment
|
1 participants
|
8 participants
|
0 participants
|
1 participants
|
Adverse Events
Low Risk Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Risk Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk Treatment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place