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

• Sponsor: Daniel Whitaker (Other)
• Overall Status: Completed
• CT.gov ID: NCT02549287
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 289
• Locations: 5
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site: 57.8
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Maltreatment	Behavioral: SafeCare; Behavioral: Supportive Case Management	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 289 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SafeCare SafeCare, an evidence-based home visiting program	Behavioral: SafeCare; An evidence-based home visiting program
Active Comparator: Supportive Case Management Child welfare services as usual	Behavioral: Supportive Case Management; Child welfare services as usual; Other Names: Services as Usual

Outcome Measures

Primary Outcome Measures

1. Parenting Young Children Scale-Supporting Positive Behavior Sub-scale [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 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).

2. Parenting Young Children Scale-Proactive Parenting Sub-scale [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 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).

3. Parenting Young Children Scale-Setting Limits Sub-scale [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 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).

4. Parenting Stress Inventory - Short Form [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).]

   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).

5. Protective Factors Survey-Parent Knowledge Sub-scale [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 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).

6. Protective Factors Survey-Family Functioning Sub-scale [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 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).

7. Brief Symptom Inventory-Significant Case Percentage [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 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.

8. BSI-Global Severity Index [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 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).

9. Devereaux Early Child Assessment-Initiative Sub-scale [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 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).

10. Devereaux Early Child Assessment-Attachment Sub-scale [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 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).

Secondary Outcome Measures

1. 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).

2. 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).

3. Family Resources Scale - Revised [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 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Iowa Family Access Center	Council Bluffs	Iowa	United States	51301
2	Children & Families of Iowa	Des Moines	Iowa	United States	50314
3	Mid Iowa Family Therapy Center	Des Moines	Iowa	United States	50324
4	Four Oaks	Iowa City	Iowa	United States	50644
5	Families First	Waterloo	Iowa	United States	50701

Sponsors and Collaborators

• Daniel Whitaker
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Daniel J Whitaker, PhD, Georgia State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 17, 2016

More Information

Publications

None provided.

• Responsible Party: Daniel Whitaker, Faculty Sponsor Investigator, Georgia State University
• ClinicalTrials.gov Identifier: NCT02549287
• Other Study ID Numbers: 90CU0062
• First Posted: Sep 15, 2015
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

Study Results

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Period Title: Overall Study
STARTED	193	96
COMPLETED	113	64
NOT COMPLETED	80	32

Baseline Characteristics

Arm/Group Title	SafeCare	Supportive Case Management	Total
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual	Total of all reporting groups
Overall Participants	193	96	289
Age (Count of Participants)
<=18 years	2 1%	1 1%	3 1%
Between 18 and 65 years	189 97.9%	93 96.9%	282 97.6%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.6 (6.9)	31.5 (9.3)	29.6 (7.9)
Sex: Female, Male (Count of Participants)
Female	159 82.4%	88 91.7%	247 85.5%
Male	32 16.6%	6 6.3%	38 13.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 5.7%	8 8.3%	19 6.6%
Not Hispanic or Latino	178 92.2%	84 87.5%	262 90.7%
Unknown or Not Reported	2 1%	2 2.1%	4 1.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	7 3.6%	5 5.2%	12 4.2%
Asian	3 1.6%	0 0%	3 1%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.3%
Black or African American	21 10.9%	15 15.6%	36 12.5%
White	147 76.2%	67 69.8%	214 74%
More than one race	1 0.5%	2 2.1%	3 1%
Unknown or Not Reported	11 5.7%	5 5.2%	16 5.5%
Region of Enrollment (Count of Participants)
Site 1	21 10.9%	6 6.3%	27 9.3%
Site 2	2 1%	5 5.2%	7 2.4%
Site 3	7 3.6%	3 3.1%	10 3.5%
Site 4	42 21.8%	5 5.2%	47 16.3%
Site 5	6 3.1%	2 2.1%	8 2.8%
Site 6	19 9.8%	2 2.1%	21 7.3%
Site 7	34 17.6%	6 6.3%	40 13.8%
Site 8	23 11.9%	27 28.1%	50 17.3%
Site 9	39 20.2%	40 41.7%	79 27.3%
Education (Count of Participants)
Less tha High School	51 26.4%	13 13.5%	64 22.1%
High School	64 33.2%	36 37.5%	100 34.6%
Some College	76 39.4%	44 45.8%	120 41.5%
Monthly Income (Count of Participants)
< $600	62 32.1%	24 25%	86 29.8%
$600-$1250	55 28.5%	29 30.2%	84 29.1%
$1250 +	47 24.4%	32 33.3%	79 27.3%
Number of children in the home (Count of Participants)
No children in the home	54 28%	41 42.7%	95 32.9%
1 child	60 31.1%	17 17.7%	77 26.6%
2 children	41 21.2%	22 22.9%	63 21.8%
3 or more childre	36 18.7%	13 13.5%	49 17%
Has a relationship partner (Count of Participants)
Count of Participants [Participants]	119 61.7%	43 44.8%	162 56.1%
Working (Count of Participants)
Count of Participants [Participants]	89 46.1%	51 53.1%	140 48.4%
Another caregiver in home (Count of Participants)
Count of Participants [Participants]	104 53.9%	49 51%	153 52.9%
Alcohol use in the last 12 months (Count of Participants)
Count of Participants [Participants]	111 57.5%	57 59.4%	168 58.1%
Illegal drug use in the last 12 months (Count of Participants)
Count of Participants [Participants]	84 43.5%	47 49%	131 45.3%
Victim of physical partner violence in the last 12 months (Count of Participants)
Count of Participants [Participants]	45 23.3%	19 19.8%	64 22.1%

Outcome Measures

1. Primary Outcome

Title	Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	189	91
Baseline	6.14	6.29
6-month Follow-up	6.43	6.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; -0.11 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Parenting Young Children Scale-Proactive Parenting Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	188	91
Baseline	5.79	6.0
6-month Follow-up	6.29	6.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; -0.20 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Parenting Young Children Scale-Setting Limits Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	188	91
Baseline	6.38	6.57
6-month Follow-up	6.69	6.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; -0.20 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Parenting Stress Inventory - Short Form
Description	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).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	191	93
Baseline	72	74
6-month Follow-up	73	74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.58 to 0.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Protective Factors Survey-Parent Knowledge Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	191	91
Baseline	6.0	6.0
6-month Follow-up	6.2	5.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; -0.27 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Protective Factors Survey-Family Functioning Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	188	91
Baseline	5.0	5.0
6-month Follow-up	5.4	5.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments	Other [Marginal Model (e.g., GEE)]
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.08 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Brief Symptom Inventory-Significant Case Percentage
Description	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).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	191	93
Baseline	80 41.5%	40 41.7%
6-month Follow-up	36 18.7%	23 24%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	BSI-Global Severity Index
Description	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).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	191	93
Baseline	0.35	0.42
6-month Follow-up	0.25	0.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.76 to 0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	Devereaux Early Child Assessment-Initiative Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	157	71
Baseline	54.92 (11.62)	54.97 (11.80)
6-month Follow-up	55.44 (11.20)	55.84 (10.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -3.70 to 2.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Mother-Child Neglect Scale (MCNS)
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	190	93
Baseline	3.68	3.64
6-month Follow-up	3.71	3.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.59 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Confusion, Hubbub, and Order Scale (CHAOS)
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	188	91
Baseline	1.47	1.47
6-month Follow-up	1.53	1.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Family Resources Scale - Revised
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	190	92
Baseline	9.0	9.0
6-month Follow-up	8.0	6.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Primary Outcome

Title	Devereaux Early Child Assessment-Attachment Sub-scale
Description	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SafeCare	Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program	Child welfare services as usual
Measure Participants	166	73
Baseline	52.4 (12.0)	53.4 (12.16)
6-month Follow-up	53.8 (12.0)	56.3 (11.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SafeCare, Supportive Case Management
	Comments	Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments	Group by time interaction effect reported here.
	Method	Marginal Model (e.g., GEE)
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -3.57 to 3.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	All-Cause Mortality was not monitored/assessed.
Arm/Group Title	SafeCare		Supportive Case Management
Arm/Group Description	SafeCare, an evidence-based home visiting program		Child welfare services as usual
All Cause Mortality
	SafeCare		Supportive Case Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	SafeCare		Supportive Case Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	SafeCare		Supportive Case Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/96 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.