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Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden

Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549287
Enrollment
289
Registered
2015-09-15
Start date
2015-09-30
Completion date
2018-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Maltreatment

Brief summary

In child welfare services, structured behavioral parenting programs have been documented to reduce important child-welfare outcomes, including child maltreatment recidivism.1-3 In this study, we attempt to learn which factors impacted implementation of an evidence-based practice (EBP) in a diversity of child-welfare serving sites and systems. The primary aim of this study was to identify and assess barriers and facilitators of implementation of a structured behavioral parenting program (SC). We utilized a qualitative research strategy that included semi-structured interviews and focus groups with several levels of staff responsible for implementing the model: program administrators, supervisors, and frontline staff (providers). Our second aim was to understand parent and provider reactions to SafeCare (SC) services and Supportive Case Management (SCM), especially parents' perceptions related to trajectory of burden, engagement, satisfaction, and perceived impact across intervention receipt. We employed mixed methods (both quantitative and qualitative data collection) to inform this question. Specifically, we (1) conducted qualitative interviews with families at two time points during the course of service, (2) collected session-by-session ratings from families on service reaction (perceived burden satisfaction, perceived effectiveness) and providers on family engagement, and (3) collected organizational environment surveys from providers at two time points. The final aim of this study wass to examine the short-term impact of SC versus SCM on client-centered outcomes. Quantitative surveys collected in the family's home at the beginning and end of services measured parenting variables, parent mental health and well-being, and child behavioral, social, and emotional well-being.

Detailed description

The study design was a cluster randomized trial, with randomization occurring at the team level within each study site. We randomized providers within each site to be trained in SafeCare (n = 96) or to continue to deliver SCM (n = 96) which allowed us to control for site differences. From a statistical power perspective, it would have been preferable to randomize clients to interventions, but the fact that teams at community-based organizations typically served a defined geographic area would have meant that home visitors within each team would have had to deliver two distinct interventions raising the likelihood of cross-contamination which, in our experience, would have not been well managed by the study. Providers that were randomized were invited to participate in the study by completing a survey at baseline and 1-year follow-up which included measures of demographics, work experience, organizational factors (culture, climate, leadership) and individual attitudes and beliefs that may affect implementation and service quality. We recruited caregivers into the research study that were receiving services from randomized providers. Measurement of client-level outcomes were collected at baseline and 6-month follow up, as well as during service provision. Both quantitative and qualitative data were collected to capture both breadth and depth of family outcomes and experiences of the interventions.74 By focusing on measures of well-being, this study holds potential to expand the way in which the program effectiveness is conceptualized. This could be particularly important for dissemination of parenting programs to at-risk parents, who may be interested in different outcomes (e.g., improving their child's behavior) than child welfare systems, and findings may be useful for making interventions more appealing to consumers. To measure barriers and facilitators to implementing an evidence-based practice (EBP), we used a qualitative research strategy that included semi-structured interviews and focus groups with several levels of staff, responsible for implementing the model: program administrators, supervisors, and frontline staff (providers). This strategy would yield insight into an array of stakeholder perspectives concerning implementation. In contrast to most implementation studies, ours is the first to conduct a complementary set of interviews and focus groups with staff who have not been trained in SC, the SCM providers.

Interventions

BEHAVIORALSafeCare

An evidence-based home visiting program

BEHAVIORALSupportive Case Management

Child welfare services as usual

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Daniel Whitaker
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Home Visitors: Home Visitors who are providing Supportive Case Management or being trained in SafeCare. * Parents: English or Spanish speaking parents with a child between the ages of 0-5 years who are receiving services from a participating site.

Exclusion criteria

* Parents under the age of 18, who have no children under the age of 6 years, or do not speak English or Spanish will be excluded from this study.

Design outcomes

Primary

MeasureTime frameDescription
Devereaux Early Child Assessment-Attachment Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Attachment sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 8-18 items (depending on child's age) that assesses the child's attachment behavior. (Example question: Did the toddler accept comfort from a familiar adult). This subscale score generates a t-score of standardized norms from a sum of the 8-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child attachment. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 52 were rated as low (n=101) and participants rating 52 and higher were rated as high (n=138).
Brief Symptom Inventory-Significant Case PercentageFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The 'significant case' definition from the BSI was used and includes those with elevated scores (higher than 2) on any of the subscales. The percentage of participants that were considered a 'significant case' is reports. The 'case' definition from the BSI, which includes elevation on any of the subscale. The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. A total score or the, Global Severity Index, is generated by calculating a mean of all 53 items; lower scores indicate lower levels of distress.
BSI-Global Severity IndexFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The Global Severity Index calculated a mean of all of the BSI subscales which includes 53 items on a 5-point scale (0=Not at all-4=Extremely). Theoretical range of means: 0-4; Actual range of means: 0.0-3.5). Higher scores indicate higher existence of symptoms. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, females scoring below .77 and males scoring below .57 were rated as low (n=197) and females rating .78 and higher and males rating .58 and higher were rated as high (n=87).
Devereaux Early Child Assessment-Initiative Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Initiative sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 11-18 items (depending on child's age) that assesses the child's initiative behavior. (Example question: Did the child do things for himself). This subscale score generates a t-score of standardized norms from a sum of the 11-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child initiation. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 56 were rated as low (n=110) and participants rating 56 and higher were rated as high (n=118).
Parenting Young Children Scale-Supporting Positive Behavior Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).The Supporting Positive Behavior sub-scale of the Parenting Young Children Scale is made up of 7 items that assess supporting positive behavior (Example question: Notice and praise your child's good behavior). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=125) and participants rating higher than 6 were rated as high (n=159).
Parenting Young Children Scale-Proactive Parenting Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).The Proactive Parenting sub-scale of the Parenting Young Children Scale is made up of 7 items that assess proactive parenting (Example question: Avoid struggles with your child by giving clear choices). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=148) and participants rating higher than 6 were rated as high (n=136).
Parenting Young Children Scale-Setting Limits Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Setting limits sub-scale of the Parenting Young Children Scale is made up of 7 items that assess limit setting (Example question: Stick to your rules and not change your mind). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6.3 or below were rated as low (n=141) and participants rating higher than 6.3 were rated as high (n=143).
Parenting Stress Inventory - Short FormFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).Parenting Stress Inventory - short form is a 36-item scale designed to measure stressors in parenthood including parental distress, dysfunctional interactions, and stressors related to having a difficult child. (Example question: Sometimes I feel like my child doesn't like me and doesn't want to be close to me). A total score generated by summing all 36 items on a 5-point scale (1=Strongly Agree - 5=Strongly Disagree). Theoretical total range: 36-180; Actual total range: 38-146. Lower scores represent more stress/dysfunction. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 71 or below were rated as low (n=136) and participants rating higher than 71 were rated as high (n=148).
Protective Factors Survey-Parent Knowledge Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).The Parent knowledge sub-scale of the Protective Factors is made up of 5 items that assess parent knowledge. (Example question: There are many times when I don't know what to do as a parent). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 3.4-7.0. Higher scores indicate higher parent knowledge. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 7 were rated as low (n=149) and participants rating 7 and higher were rated as high (n=133).
Protective Factors Survey-Family Functioning Sub-scaleFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).The Family Functioning sub-scale of the Protective Factors is made up of 5 items that assess family functioning. (Example question: My family pulls together when things are stressful). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores indicate higher family functioning. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 6 were rated as low (n=146) and participants rating 6 and higher were rated as high (n=133).

Secondary

MeasureTime frameDescription
Confusion, Hubbub, and Order Scale (CHAOS)Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The CHAOS scale (Confusion, Hubbub, and Order) is a 15-item scale used to measure structure and chaos in the home environment. (Example question: There is very little commotion in our home). A total score generated by calculating a mean of all 15 items on a 4-point scale (1=Very much like your own home - 4=Not at all like your own home). Theoretical range of means: 1-4; Actual range of means: 1.0-2.7. Lower scores indicate less chaos. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 1.5 or below were rated as low (n=151) and participants rating higher than 1.5 were rated as high (n=133).
Family Resources Scale - RevisedFamilies were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Family Resources Scale - Revised is a 40-item scale that assesses the adequacy of family needs in four domains: basic needs, money, time for self, and time for family. (Example question: How well is the following need being met: House or apartment). A total count of resources needed out of 40 assessed. Resources were considered needed if the participant indicated the resource was 'Not at all' met, 'A little' met, or 'Sometimes' met (5-point scale: 1=Not at all - 5=Almost always). Theoretical range of means: 0-40; Actual range of means: 0-40. Higher ratings indicating a higher number of resources needed. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants with 9 or fewer needs not met were rated as low (n=152) and participants with 10 and higher needs not met were rated as high (n=132).
Mother-Child Neglect Scale (MCNS)Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).The Mother-Child Neglect Scale (MCNS) is a 22-item scale designed to assess caregiving behaviors in four domains: physical, cognitive, supervision, and emotional needs. (Example question: I make sure my child sees a doctor when he/she needs one). A total score generated by calculating a mean of the 22 items rated on a 4-point scale (1=Strongly Agree - 4=Strongly Disagree). Theoretical range of means: 1-4; Actual range of means: 1.2-3.9. Lower scores indicate less neglectful behaviors. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 3.65 and below were rated as low (n=139) and participants rating higher than 3.65 were rated as high (n=145).

Countries

United States

Participant flow

Recruitment details

Eligible participants were caregivers 18 or older, receiving services from a randomized provider, and had a child five or under. Participants were introduced to the study opportunity by their provider during a visit who referred interested participants to the Georgia State University-based research team to review the study procedures.

Participants by arm

ArmCount
SafeCare
SafeCare, an evidence-based home visiting program
193
Supportive Case Management
Child welfare services as usual
96
Total289

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up6526
Overall StudyWithdrawal by Subject156

Baseline characteristics

CharacteristicSafeCareTotalSupportive Case Management
Age, Categorical
<=18 years
2 Participants3 Participants1 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
189 Participants282 Participants93 Participants
Age, Continuous28.6 years
STANDARD_DEVIATION 6.9
29.6 years
STANDARD_DEVIATION 7.9
31.5 years
STANDARD_DEVIATION 9.3
Alcohol use in the last 12 months111 Participants168 Participants57 Participants
Another caregiver in home104 Participants153 Participants49 Participants
Education
High School
64 Participants100 Participants36 Participants
Education
Less tha High School
51 Participants64 Participants13 Participants
Education
Some College
76 Participants120 Participants44 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants19 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
178 Participants262 Participants84 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants4 Participants2 Participants
Has a relationship partner119 Participants162 Participants43 Participants
Illegal drug use in the last 12 months84 Participants131 Participants47 Participants
Monthly Income
$1250 +
47 Participants79 Participants32 Participants
Monthly Income
< $600
62 Participants86 Participants24 Participants
Monthly Income
$600-$1250
55 Participants84 Participants29 Participants
Number of children in the home
1 child
60 Participants77 Participants17 Participants
Number of children in the home
2 children
41 Participants63 Participants22 Participants
Number of children in the home
3 or more childre
36 Participants49 Participants13 Participants
Number of children in the home
No children in the home
54 Participants95 Participants41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
7 Participants12 Participants5 Participants
Race (NIH/OMB)
Asian
3 Participants3 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants36 Participants15 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants16 Participants5 Participants
Race (NIH/OMB)
White
147 Participants214 Participants67 Participants
Region of Enrollment
United States
Site 1
21 Participants27 Participants6 Participants
Region of Enrollment
United States
Site 2
2 Participants7 Participants5 Participants
Region of Enrollment
United States
Site 3
7 Participants10 Participants3 Participants
Region of Enrollment
United States
Site 4
42 Participants47 Participants5 Participants
Region of Enrollment
United States
Site 5
6 Participants8 Participants2 Participants
Region of Enrollment
United States
Site 6
19 Participants21 Participants2 Participants
Region of Enrollment
United States
Site 7
34 Participants40 Participants6 Participants
Region of Enrollment
United States
Site 8
23 Participants50 Participants27 Participants
Region of Enrollment
United States
Site 9
39 Participants79 Participants40 Participants
Sex: Female, Male
Female
159 Participants247 Participants88 Participants
Sex: Female, Male
Male
32 Participants38 Participants6 Participants
Victim of physical partner violence in the last 12 months45 Participants64 Participants19 Participants
Working89 Participants140 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 1930 / 96
serious
Total, serious adverse events
0 / 1930 / 96

Outcome results

Primary

Brief Symptom Inventory-Significant Case Percentage

The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The 'significant case' definition from the BSI was used and includes those with elevated scores (higher than 2) on any of the subscales. The percentage of participants that were considered a 'significant case' is reports. The 'case' definition from the BSI, which includes elevation on any of the subscale. The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. A total score or the, Global Severity Index, is generated by calculating a mean of all 53 items; lower scores indicate lower levels of distress.

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SafeCareBrief Symptom Inventory-Significant Case PercentageBaseline80 Participants
SafeCareBrief Symptom Inventory-Significant Case Percentage6-month Follow-up36 Participants
Supportive Case ManagementBrief Symptom Inventory-Significant Case PercentageBaseline40 Participants
Supportive Case ManagementBrief Symptom Inventory-Significant Case Percentage6-month Follow-up23 Participants
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.6195% CI: [-0.73, 0.52]Marginal Model (e.g., GEE)
Primary

BSI-Global Severity Index

The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The Global Severity Index calculated a mean of all of the BSI subscales which includes 53 items on a 5-point scale (0=Not at all-4=Extremely). Theoretical range of means: 0-4; Actual range of means: 0.0-3.5). Higher scores indicate higher existence of symptoms. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, females scoring below .77 and males scoring below .57 were rated as low (n=197) and females rating .78 and higher and males rating .58 and higher were rated as high (n=87).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population.

ArmMeasureGroupValue (MEDIAN)
SafeCareBSI-Global Severity IndexBaseline0.35 units on a scale
SafeCareBSI-Global Severity Index6-month Follow-up0.25 units on a scale
Supportive Case ManagementBSI-Global Severity IndexBaseline0.42 units on a scale
Supportive Case ManagementBSI-Global Severity Index6-month Follow-up0.37 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.4795% CI: [-0.76, 0.32]Marginal Model (e.g., GEE)
Primary

Devereaux Early Child Assessment-Attachment Sub-scale

The Attachment sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 8-18 items (depending on child's age) that assesses the child's attachment behavior. (Example question: Did the toddler accept comfort from a familiar adult). This subscale score generates a t-score of standardized norms from a sum of the 8-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child attachment. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 52 were rated as low (n=101) and participants rating 52 and higher were rated as high (n=138).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions. Lastly, errors in survey branching based on child's age required discarding those responses which reduced the total number of participants analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
SafeCareDevereaux Early Child Assessment-Attachment Sub-scaleBaseline52.4 units on a scaleStandard Deviation 12
SafeCareDevereaux Early Child Assessment-Attachment Sub-scale6-month Follow-up53.8 units on a scaleStandard Deviation 12
Supportive Case ManagementDevereaux Early Child Assessment-Attachment Sub-scaleBaseline53.4 units on a scaleStandard Deviation 12.16
Supportive Case ManagementDevereaux Early Child Assessment-Attachment Sub-scale6-month Follow-up56.3 units on a scaleStandard Deviation 11.3
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.6395% CI: [-3.57, 3.22]Marginal Model (e.g., GEE)
Primary

Devereaux Early Child Assessment-Initiative Sub-scale

The Initiative sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 11-18 items (depending on child's age) that assesses the child's initiative behavior. (Example question: Did the child do things for himself). This subscale score generates a t-score of standardized norms from a sum of the 11-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child initiation. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 56 were rated as low (n=110) and participants rating 56 and higher were rated as high (n=118).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions. Lastly, errors in survey branching based on child's age required discarding those responses which reduced the total number of participants analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
SafeCareDevereaux Early Child Assessment-Initiative Sub-scaleBaseline54.92 units on a scaleStandard Deviation 11.62
SafeCareDevereaux Early Child Assessment-Initiative Sub-scale6-month Follow-up55.44 units on a scaleStandard Deviation 11.2
Supportive Case ManagementDevereaux Early Child Assessment-Initiative Sub-scaleBaseline54.97 units on a scaleStandard Deviation 11.8
Supportive Case ManagementDevereaux Early Child Assessment-Initiative Sub-scale6-month Follow-up55.84 units on a scaleStandard Deviation 10.34
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.6595% CI: [-3.7, 2.2]Marginal Model (e.g., GEE)
Primary

Parenting Stress Inventory - Short Form

Parenting Stress Inventory - short form is a 36-item scale designed to measure stressors in parenthood including parental distress, dysfunctional interactions, and stressors related to having a difficult child. (Example question: Sometimes I feel like my child doesn't like me and doesn't want to be close to me). A total score generated by summing all 36 items on a 5-point scale (1=Strongly Agree - 5=Strongly Disagree). Theoretical total range: 36-180; Actual total range: 38-146. Lower scores represent more stress/dysfunction. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 71 or below were rated as low (n=136) and participants rating higher than 71 were rated as high (n=148).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population.

ArmMeasureGroupValue (MEDIAN)
SafeCareParenting Stress Inventory - Short FormBaseline72 units on a scale
SafeCareParenting Stress Inventory - Short Form6-month Follow-up73 units on a scale
Supportive Case ManagementParenting Stress Inventory - Short FormBaseline74 units on a scale
Supportive Case ManagementParenting Stress Inventory - Short Form6-month Follow-up74 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.7795% CI: [-0.58, 0.43]Marginal Model (e.g., GEE)
Primary

Parenting Young Children Scale-Proactive Parenting Sub-scale

The Proactive Parenting sub-scale of the Parenting Young Children Scale is made up of 7 items that assess proactive parenting (Example question: Avoid struggles with your child by giving clear choices). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=148) and participants rating higher than 6 were rated as high (n=136).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareParenting Young Children Scale-Proactive Parenting Sub-scaleBaseline5.79 units on a scale
SafeCareParenting Young Children Scale-Proactive Parenting Sub-scale6-month Follow-up6.29 units on a scale
Supportive Case ManagementParenting Young Children Scale-Proactive Parenting Sub-scaleBaseline6.0 units on a scale
Supportive Case ManagementParenting Young Children Scale-Proactive Parenting Sub-scale6-month Follow-up6.14 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.1495% CI: [-0.2, 1.03]Marginal Model (e.g., GEE)
Primary

Parenting Young Children Scale-Setting Limits Sub-scale

The Setting limits sub-scale of the Parenting Young Children Scale is made up of 7 items that assess limit setting (Example question: Stick to your rules and not change your mind). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6.3 or below were rated as low (n=141) and participants rating higher than 6.3 were rated as high (n=143).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareParenting Young Children Scale-Setting Limits Sub-scale6-month Follow-up6.69 units on a scale
SafeCareParenting Young Children Scale-Setting Limits Sub-scaleBaseline6.38 units on a scale
Supportive Case ManagementParenting Young Children Scale-Setting Limits Sub-scaleBaseline6.57 units on a scale
Supportive Case ManagementParenting Young Children Scale-Setting Limits Sub-scale6-month Follow-up6.57 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.295% CI: [-0.2, 1.07]Marginal Model (e.g., GEE)
Primary

Parenting Young Children Scale-Supporting Positive Behavior Sub-scale

The Supporting Positive Behavior sub-scale of the Parenting Young Children Scale is made up of 7 items that assess supporting positive behavior (Example question: Notice and praise your child's good behavior). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=125) and participants rating higher than 6 were rated as high (n=159).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareParenting Young Children Scale-Supporting Positive Behavior Sub-scaleBaseline6.14 units on a scale
SafeCareParenting Young Children Scale-Supporting Positive Behavior Sub-scale6-month Follow-up6.43 units on a scale
Supportive Case ManagementParenting Young Children Scale-Supporting Positive Behavior Sub-scaleBaseline6.29 units on a scale
Supportive Case ManagementParenting Young Children Scale-Supporting Positive Behavior Sub-scale6-month Follow-up6.29 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.1295% CI: [-0.11, 1.2]Marginal Model (e.g., GEE)
Primary

Protective Factors Survey-Family Functioning Sub-scale

The Family Functioning sub-scale of the Protective Factors is made up of 5 items that assess family functioning. (Example question: My family pulls together when things are stressful). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores indicate higher family functioning. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 6 were rated as low (n=146) and participants rating 6 and higher were rated as high (n=133).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population.

ArmMeasureGroupValue (MEDIAN)
SafeCareProtective Factors Survey-Family Functioning Sub-scale6-month Follow-up5.4 units on a scale
SafeCareProtective Factors Survey-Family Functioning Sub-scaleBaseline5.0 units on a scale
Supportive Case ManagementProtective Factors Survey-Family Functioning Sub-scaleBaseline5.0 units on a scale
Supportive Case ManagementProtective Factors Survey-Family Functioning Sub-scale6-month Follow-up5.2 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.1595% CI: [-0.08, 1.06]Marginal Model (e.g., GEE)
Primary

Protective Factors Survey-Parent Knowledge Sub-scale

The Parent knowledge sub-scale of the Protective Factors is made up of 5 items that assess parent knowledge. (Example question: There are many times when I don't know what to do as a parent). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 3.4-7.0. Higher scores indicate higher parent knowledge. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 7 were rated as low (n=149) and participants rating 7 and higher were rated as high (n=133).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population.

ArmMeasureGroupValue (MEDIAN)
SafeCareProtective Factors Survey-Parent Knowledge Sub-scaleBaseline6.0 units on a scale
SafeCareProtective Factors Survey-Parent Knowledge Sub-scale6-month Follow-up6.2 units on a scale
Supportive Case ManagementProtective Factors Survey-Parent Knowledge Sub-scaleBaseline6.0 units on a scale
Supportive Case ManagementProtective Factors Survey-Parent Knowledge Sub-scale6-month Follow-up5.9 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.2995% CI: [-0.27, 0.97]Marginal Model (e.g., GEE)
Secondary

Confusion, Hubbub, and Order Scale (CHAOS)

The CHAOS scale (Confusion, Hubbub, and Order) is a 15-item scale used to measure structure and chaos in the home environment. (Example question: There is very little commotion in our home). A total score generated by calculating a mean of all 15 items on a 4-point scale (1=Very much like your own home - 4=Not at all like your own home). Theoretical range of means: 1-4; Actual range of means: 1.0-2.7. Lower scores indicate less chaos. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 1.5 or below were rated as low (n=151) and participants rating higher than 1.5 were rated as high (n=133).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareConfusion, Hubbub, and Order Scale (CHAOS)Baseline1.47 units on a scale
SafeCareConfusion, Hubbub, and Order Scale (CHAOS)6-month Follow-up1.53 units on a scale
Supportive Case ManagementConfusion, Hubbub, and Order Scale (CHAOS)Baseline1.47 units on a scale
Supportive Case ManagementConfusion, Hubbub, and Order Scale (CHAOS)6-month Follow-up1.47 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.4495% CI: [-0.79, 0.29]Marginal Model (e.g., GEE)
Secondary

Family Resources Scale - Revised

The Family Resources Scale - Revised is a 40-item scale that assesses the adequacy of family needs in four domains: basic needs, money, time for self, and time for family. (Example question: How well is the following need being met: House or apartment). A total count of resources needed out of 40 assessed. Resources were considered needed if the participant indicated the resource was 'Not at all' met, 'A little' met, or 'Sometimes' met (5-point scale: 1=Not at all - 5=Almost always). Theoretical range of means: 0-40; Actual range of means: 0-40. Higher ratings indicating a higher number of resources needed. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants with 9 or fewer needs not met were rated as low (n=152) and participants with 10 and higher needs not met were rated as high (n=132).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareFamily Resources Scale - RevisedBaseline9.0 units on a scale
SafeCareFamily Resources Scale - Revised6-month Follow-up8.0 units on a scale
Supportive Case ManagementFamily Resources Scale - Revised6-month Follow-up6.5 units on a scale
Supportive Case ManagementFamily Resources Scale - RevisedBaseline9.0 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.4795% CI: [-0.39, 0.89]Marginal Model (e.g., GEE)
Secondary

Mother-Child Neglect Scale (MCNS)

The Mother-Child Neglect Scale (MCNS) is a 22-item scale designed to assess caregiving behaviors in four domains: physical, cognitive, supervision, and emotional needs. (Example question: I make sure my child sees a doctor when he/she needs one). A total score generated by calculating a mean of the 22 items rated on a 4-point scale (1=Strongly Agree - 4=Strongly Disagree). Theoretical range of means: 1-4; Actual range of means: 1.2-3.9. Lower scores indicate less neglectful behaviors. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 3.65 and below were rated as low (n=139) and participants rating higher than 3.65 were rated as high (n=145).

Time frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).

Population: Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.

ArmMeasureGroupValue (MEDIAN)
SafeCareMother-Child Neglect Scale (MCNS)Baseline3.68 units on a scale
SafeCareMother-Child Neglect Scale (MCNS)6-month Follow-up3.71 units on a scale
Supportive Case ManagementMother-Child Neglect Scale (MCNS)Baseline3.64 units on a scale
Supportive Case ManagementMother-Child Neglect Scale (MCNS)6-month Follow-up3.67 units on a scale
Comparison: Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.p-value: 0.6495% CI: [-0.59, 0.69]Marginal Model (e.g., GEE)

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026