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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50HD096719 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Childhood Maltreatment (CM) has highly deleterious effects on human development and is a preventable known cause of enduring psychopathology in the United States. Infants and young children are at particularly high risk for physical harm from abuse and neglect, comprising over 60% of all child maltreatment fatalities. An increasing number of studies point to the ability to target prevention of CM by estimating individual specific risk at the time of birth, on the basis of readily-accessible data elements of birth records. This clinical trial was a small randomized controlled trial embedded within a prospective longitudinal study, in which families of infants recruited prenatally or in the newborn period are randomized to an enhanced level of engagement in resource navigation, which we refer to as Personalized Education Regarding Clinical and Community Supports (PERCCS). The enhancement involves keying recommendations for evidence-informed interventions for the prevention of CM to established risk factors for ascertained within a family.
The parent longitudinal cohort study involves enrollment of a diverse population of families of newborns (prenatally or in the immediate postnatal period) for the purpose of ascertaining sociodemographic, psychological (eg. parental stress) and family psychiatric risk factors for (a) child maltreatment (b) unmet service needs, and (c) adverse behavioral outcomes of the children. Families are contacted quarterly to track acquisition of support services that are relevant to the prevention of child maltreatment. At age 18 months early childhood behavioral outcomes are ascertained and official-report child maltreatment records from the State of Missouri are individually cross-matched with identifiers of the children and their parents.
Two major outcomes are examined:
The first is whether the engagement protocol results in a higher level of acquisition and active participation in recommended preventive intervention services by the families (including home visitation, parental mental health care, evidence-based parenting education, and others delineated in Table 1, see below).
The second is the rate of child maltreatment (CM) ascertained in official Missouri state administrative records for which individual informed consent to individually-cross reference is obtained by the families in the course of their enrollment in the parent longitudinal study.
Sample: The sample will be recruited from the Washington University School of Medicine Obstetrical Service within the Barnes Jewish Christian (BJC) Health System, on which there are over 3000 Missouri childbirths per year, serving an urban population of families that are disproportionately affected by poverty. Fifty-five per cent of patients report a family income less than $20,000, 65% of the mothers are unemployed, and the majority of the newborns are on Medicaid or are Medicaid-eligible. In preliminary screening efforts, over one third of the mothers reported their own childhood histories of maltreatment, and approximately one half score in the clinical range for depressive symptomatology.
Methods: A schematic summarizing study enrollment, participant randomization, and ascertainment of outcomes is provided in Figure 1.
Study Approach and Design: Consent was in three phases to reduce burden on mothers. A total of N=400 families were the target for recruitment in the parent longitudinal study. The consent period was delayed by the onset of COVID and switching to virtual recruitment. A total of 399 were consented during phase I which included a limited screen and match to birth records. Phase II included the full risk screen with referrals. Phase III consent was conducted from the Phase II consents for for nested RCT on a rolling basis. Among those who fall in an elevated risk category (or 3+ risks) or lower category (under 3) we planned to randomize 150 families 2:1 to Personalized Education Regarding Clinical and Community Supports (PERCCS) versus Usual Care. The total final recruitment was 105 (78 from the higher risk count group and 27 from the lower risk count group). Risk counts for phase III assignment were calculated by the total number of established predictors of risk for CM ascertained from birth records. Utilization of community-based evidence-informed support services were ascertained at baseline and quarterly thereafter for all study participants. PERCCS responded to the full array of risks present in Table 1. Official-report Child Maltreatment data from Missouri state administrative data will be individually linked with participant research records when the children reach 18 months of age.
PERCCS involves i) a review with the mother of all family CM risks ascertained in the context of their own individual screening ii) recommendations of community and clinical interventions which substantively respond to those risks and are available to the subject (on the basis of each individual subject's zip code, insurance, and eligibility for the interventions), collectively the personalized family resource plan, iii) facilitation of contact between the subject and the respective provider agencies to initiate enrollment; and iv) authorization for the research team to share the personalized risk profile and support recommendations with the infant's outpatient primary care provider.
The community and clinical supports responsive to specific risk factors are listed in Table 1, which summarizes the array of evidence-informed preventions that will be presented to the families, and the correspondence with each to specific CM risks ascertained within a family. Table 2 depicts the set of scripts which are used by the study team to standardize all aspects of the review of endorsed risks, their potential adverse effects on parenting, and the opportunities for mitigation through evidence-informed intervention.
All participants will receive care as usual, including the provision of a summary document itemizing key community supports for families of infants, a continuously-updated local community resource handbook, a published parenting guide, and opportunity to enroll free-of-charge in a virtual parenting education and developmental surveillance program, babynavigator.com.
Key Measures:
The Utilization of Community Services (UCS) is a survey that will be used to ascertain engagement of families in community supports and interventions, including tracking of both frequency and duration. This survey is completed at the time of study enrollment to establish a baseline, and quarterly thereafter until the completion of the study when a child reaches 18 months of age.
State Records: The second primary outcome, rate of child maltreatment, will rely on official state records from the State of Missouri Department of Social Services. Participants are aware that accessing service records or CM report data are retrospective when acquired and do not pose any risk or liability to them nor can it impact services received.
Planned Statistical Analyses:
I. Intent-to-treat analysis of impact of PERCCS on service utilization. We will calculate the total proportion of evidence-informed services indicated by risk profiles of all families within each group (the intervention group and the control group) and compare the groups using chi square analysis.
II. Intent-to-treat analysis of the impact of PERCCS on the occurrence of child maltreatment. We compared the rate of official-report abuse/neglect between the groups using chi square analysis.
III. (Secondary) We planned to conduct logistic regression analysis simultaneously examining the effects of risk count and service access on official report child maltreatment outcome, but the final sample size precluded multivariate assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Active Comparator | Low risk natural history study (planned was n=250*; actual n=174). Of the 174, 105 families consented to the RCT *Participants who consented to the RCT were randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" birth record risk counts (planned n=105l; actual n=78) families for child maltreatment or "low risk" counts (planned n=45; actual n=27) families. |
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| High Risk | Experimental | High risk families in prospective longitudinal study of newborns (planned n=150*; actual n=225). A total of 150 families were planned and a final 105 families consented to the RCT *Participants were randomized 2:1 PERCCS:Control, and the randomization in successive sets of three families who fall in either "high risk" birth record risk counts (planned n=105; actual n=78) families for child maltreatment or "low risk" counts (planned n=45; actual n=27) families. Participants in this arm will be randomized to:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERCCS: Personalized Education Regarding Clinical and Community Supports | Behavioral | A brief follow-up to the screening provided to 50% of the consented families (randomly assigned) that links their specific familial risks to community interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Service Utilization | Mean number of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up. | Not more than 18 months postpartum |
| Child Maltreatment | 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 | Not more than 18 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mini Tandon, DO | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26980121 | Background | Constantino JN. Child Maltreatment Prevention and the Scope of Child and Adolescent Psychiatry. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):157-65. doi: 10.1016/j.chc.2015.11.003. Epub 2016 Jan 11. | |
| 28375720 | Background | Jaffee SR. Child Maltreatment and Risk for Psychopathology in Childhood and Adulthood. Annu Rev Clin Psychol. 2017 May 8;13:525-551. doi: 10.1146/annurev-clinpsy-032816-045005. Epub 2017 Mar 30. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
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| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2022 |
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Single (study personnel blind to intervention allocation status)
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| Background | US DHHS, Children's Bureau (2017). Child Maltreatment 2015. Washington, DC: Author.U.S. |
| 15607768 | Background | Wu SS, Ma CX, Carter RL, Ariet M, Feaver EA, Resnick MB, Roth J. Risk factors for infant maltreatment: a population-based study. Child Abuse Negl. 2004 Dec;28(12):1253-64. doi: 10.1016/j.chiabu.2004.07.005. |
| Background | Putnam-Hornstein, E., & Needell, B. (2011). Predictors of child protective service contact between birth and age five: An examination of California's 2002 birth cohort. Children and Youth Services Review, 33(8), 1337-1344. |
| 19056114 | Background | Gilbert R, Widom CS, Browne K, Fergusson D, Webb E, Janson S. Burden and consequences of child maltreatment in high-income countries. Lancet. 2009 Jan 3;373(9657):68-81. doi: 10.1016/S0140-6736(08)61706-7. Epub 2008 Dec 4. |
| Background | Paulsell, D., Avellar, S., Sama Martin, E., & Del Grosso, P. Home Visiting Evidence of Effectiveness Review: Executive Summary. Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. 2011. Washington, DC. |
| 22529281 | Background | Jonson-Reid M, Kohl PL, Drake B. Child and adult outcomes of chronic child maltreatment. Pediatrics. 2012 May;129(5):839-45. doi: 10.1542/peds.2011-2529. Epub 2012 Apr 23. |
| 35690303 | Derived | Tandon M, Jonson-Reid M, Constantino JN. Documenting Opportunity for Systematic Identification and Mitigation of Risk for Child Maltreatment. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1313-1316. doi: 10.1016/j.jaac.2022.05.008. Epub 2022 Jun 8. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk Control | Low risk families had two or fewer birth record risks and assigned 2:1 to control with 9 in control. |
| BG001 | High Risk Control | High risk families had three or more birth record risks and assigned 2:1 to control with 25 in control. |
| BG002 | Low Risk Treatment | Low risk families had two or fewer birth record risks and assigned 2:1 to control with 18 in treatment group. |
| BG003 | High Risk Treatment | High risk families had three or more birth record risks and assigned 2:1 to control with 53 in treatment group. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | date of birth was used as the baseline instead of consent date because some moms were consented a little before birth but technically the study doesn't start until child's birth; the baseline risk level was assessed by electronic birth records. So it was thought that this method would be more consistent than mom's age at time of consent. In order to get an age from mom's date of birth one has to have a date to which to compare it. So we took mom's dob and subtracted it from child DOB and divided by 365.25 to get the age of the mom when child was born | Mean | Standard Deviation | years |
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| Sex: Female, Male | Maternal caregiver self-identified sex | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Caregiver self-identified race and ethnicity according to OMB originally but sample was very small and regional demographics required recode | Count of Participants | Participants |
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| Region of Enrollment | All data were collected in the same Midwestern US urban region | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Service Utilization | Mean number of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up. | Service use is only available for those with 18 month follow-up so the number analyzed is less for this outcome. | Posted | Mar 2026 | Mean | Standard Deviation | count of services | Not more than 18 months postpartum |
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| Primary | Child Maltreatment | 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 | 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. | Posted | Number | participants | Not more than 18 months postpartum |
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study start to study completion (18 months from time of enrollment or 18 months postpartum for the few enrolled just prior to birth)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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 instead of 250 low risk at Consent Stage One the number was 174. Consent for RCT was rolling with target of 45 families(in triples), but because of study COVID recruitment delays and the need to follow for -18 months postpartum for those consented slightly before birth or 18 months following consent for those consented following the birth- only 27 could be consented. 18 of the 27 low risk families were assigned to the treatment condition. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | 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 instead of 150 high risk at Consent stage one the number was 225. Consent for RCT was rolling with target of 105 families(in triples), but because of study COVID recruitment delays and the need to follow for -18 months postpartum for those consented slightly before birth or 18 months following consent for those consented following the birth- only 78 could be consented. 25 of the 78 high risk families were assigned to the control condition. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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 instead of 250 low risk at Consent Stage One the number was 174. Consent for RCT was rolling with target of 45 families(in triples), but because of study COVID recruitment delays and the need to follow for -18 months postpartum for those consented slightly before birth or 18 months following consent for those consented following the birth- only 27 could be consented. 9 of the 27 low risk families were assigned to the control condition. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | 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 instead of 150 high risk at Consent stage one the number was 225. Consent for RCT was rolling with target of 105 families(in triples), but because of study COVID recruitment delays and the need to follow for -18 months postpartum for those consented slightly before birth or 18 months following consent for those consented following the birth- only 78 could be consented. 53 of the 78 high risk families were assigned to the treatment condition. | 0 | 53 | 0 | 53 | 0 | 53 |
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COVID delays impacting the onset of the consent extended the recruitment period which ultimately impacted the end date for recruiting into the RCT portion in order to provide the 18 month follow-up window.
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| Title | Organization | Phone | Extension | |
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| Mini Tandon | Washington University | 3142861700 | tandonm@wustl.edu |
| Mar 9, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
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| D000091443 | Community Support |
| ID | Term |
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| D003256 | Community Participation |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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).
| OG003 | High Risk Control | 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:
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