Trial Outcomes & Findings for Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden (NCT NCT02549287)

NCT ID: NCT02549287

Last Updated: 2020-01-13

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

289 participants

Primary outcome timeframe

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).

Results posted on

2020-01-13

Participant Flow

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.

Unit of analysis: Team

Participant milestones

Participant milestones
Measure
SafeCare
SafeCare, an evidence-based home visiting program
Supportive Case Management
Child welfare services as usual
Overall Study
STARTED
193 17
96 15
Overall Study
COMPLETED
113 17
64 15
Overall Study
NOT COMPLETED
80 0
32 0

Reasons for withdrawal

Reasons for withdrawal
Measure
SafeCare
SafeCare, an evidence-based home visiting program
Supportive Case Management
Child welfare services as usual
Overall Study
Lost to Follow-up
65
26
Overall Study
Withdrawal by Subject
15
6

Baseline Characteristics

Data for 4 surveys were corrupted causing Row population to differ from the Overall Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SafeCare
n=193 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=96 Participants
Child welfare services as usual
Total
n=289 Participants
Total of all reporting groups
Age, Categorical
<=18 years
2 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
1 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
3 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
Age, Categorical
Between 18 and 65 years
189 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
93 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
282 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
Age, Categorical
>=65 years
0 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
0 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
0 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall Population
Age, Continuous
28.6 years
STANDARD_DEVIATION 6.9 • n=191 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population
31.5 years
STANDARD_DEVIATION 9.3 • n=94 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population
29.6 years
STANDARD_DEVIATION 7.9 • n=285 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population
Sex: Female, Male
Female
159 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
88 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
247 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
Sex: Female, Male
Male
32 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
6 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
38 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the overall population
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
8 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
19 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Ethnicity (NIH/OMB)
Not Hispanic or Latino
178 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
84 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
262 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
2 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
4 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
American Indian or Alaska Native
7 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
5 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
12 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
Asian
3 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
0 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
3 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
0 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
1 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
Black or African American
21 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
15 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
36 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
White
147 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
67 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
214 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
More than one race
1 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
2 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
3 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
5 Participants
n=94 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
16 Participants
n=285 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population
Region of Enrollment
United States · Site 1
21 Participants
n=193 Participants
6 Participants
n=96 Participants
27 Participants
n=289 Participants
Region of Enrollment
United States · Site 2
2 Participants
n=193 Participants
5 Participants
n=96 Participants
7 Participants
n=289 Participants
Region of Enrollment
United States · Site 3
7 Participants
n=193 Participants
3 Participants
n=96 Participants
10 Participants
n=289 Participants
Region of Enrollment
United States · Site 4
42 Participants
n=193 Participants
5 Participants
n=96 Participants
47 Participants
n=289 Participants
Region of Enrollment
United States · Site 5
6 Participants
n=193 Participants
2 Participants
n=96 Participants
8 Participants
n=289 Participants
Region of Enrollment
United States · Site 6
19 Participants
n=193 Participants
2 Participants
n=96 Participants
21 Participants
n=289 Participants
Region of Enrollment
United States · Site 7
34 Participants
n=193 Participants
6 Participants
n=96 Participants
40 Participants
n=289 Participants
Region of Enrollment
United States · Site 8
23 Participants
n=193 Participants
27 Participants
n=96 Participants
50 Participants
n=289 Participants
Region of Enrollment
United States · Site 9
39 Participants
n=193 Participants
40 Participants
n=96 Participants
79 Participants
n=289 Participants
Education
Less tha High School
51 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
13 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
64 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
Education
High School
64 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
36 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
100 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
Education
Some College
76 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
44 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
120 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided their level of education resulting in missing data.
Monthly Income
< $600
62 Participants
n=164 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
24 Participants
n=85 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
86 Participants
n=249 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
Monthly Income
$600-$1250
55 Participants
n=164 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
29 Participants
n=85 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
84 Participants
n=249 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
Monthly Income
$1250 +
47 Participants
n=164 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
32 Participants
n=85 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
79 Participants
n=249 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on their income resulting in missing data.
Number of children in the home
No children in the home
54 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
41 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
95 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
Number of children in the home
1 child
60 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
17 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
77 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
Number of children in the home
2 children
41 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
22 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
63 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
Number of children in the home
3 or more childre
36 Participants
n=191 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
13 Participants
n=93 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
49 Participants
n=284 Participants • Data for 4 surveys were corrupted causing Row population to differ from the Overall population. In addition, not all participants provided information on the number of children in their home resulting in missing data.
Has a relationship partner
119 Participants
n=188 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on relationship status.
43 Participants
n=92 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on relationship status.
162 Participants
n=280 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on relationship status.
Working
89 Participants
n=191 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
51 Participants
n=94 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
140 Participants
n=285 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
Another caregiver in home
104 Participants
n=191 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
49 Participants
n=94 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
153 Participants
n=285 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population.
Alcohol use in the last 12 months
111 Participants
n=190 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on alcohol use history.
57 Participants
n=93 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on alcohol use history.
168 Participants
n=283 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on alcohol use history.
Illegal drug use in the last 12 months
84 Participants
n=190 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on illegal drug use history.
47 Participants
n=93 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on illegal drug use history.
131 Participants
n=283 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on illegal drug use history.
Victim of physical partner violence in the last 12 months
45 Participants
n=169 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on their physical partner violence history.
19 Participants
n=80 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on their physical partner violence history.
64 Participants
n=249 Participants • Data for 4 surveys were corrupted causing the Row population to differ from the Overall population. In addition, not all participants provided information on their physical partner violence history.

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=189 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
Baseline
6.14 units on a scale
Interval 1.0 to 7.0
6.29 units on a scale
Interval 3.14 to 7.0
Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
6-month Follow-up
6.43 units on a scale
Interval 1.57 to 7.0
6.29 units on a scale
Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=188 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Parenting Young Children Scale-Proactive Parenting Sub-scale
Baseline
5.79 units on a scale
Interval 1.0 to 7.0
6.0 units on a scale
Interval 1.0 to 7.0
Parenting Young Children Scale-Proactive Parenting Sub-scale
6-month Follow-up
6.29 units on a scale
Interval 1.0 to 7.0
6.14 units on a scale
Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=188 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Parenting Young Children Scale-Setting Limits Sub-scale
Baseline
6.38 units on a scale
Interval 1.0 to 7.0
6.57 units on a scale
Interval 1.0 to 7.0
Parenting Young Children Scale-Setting Limits Sub-scale
6-month Follow-up
6.69 units on a scale
Interval 1.0 to 7.0
6.57 units on a scale
Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=191 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=93 Participants
Child welfare services as usual
Parenting Stress Inventory - Short Form
Baseline
72 units on a scale
Interval 40.0 to 152.0
74 units on a scale
Interval 40.0 to 150.0
Parenting Stress Inventory - Short Form
6-month Follow-up
73 units on a scale
Interval 41.0 to 140.0
74 units on a scale
Interval 43.0 to 176.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=191 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Protective Factors Survey-Parent Knowledge Sub-scale
Baseline
6.0 units on a scale
Interval 3.4 to 7.0
6.0 units on a scale
Interval 3.6 to 7.0
Protective Factors Survey-Parent Knowledge Sub-scale
6-month Follow-up
6.2 units on a scale
Interval 3.4 to 7.0
5.9 units on a scale
Interval 3.4 to 7.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=188 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Protective Factors Survey-Family Functioning Sub-scale
Baseline
5.0 units on a scale
Interval 1.0 to 7.0
5.0 units on a scale
Interval 1.0 to 7.0
Protective Factors Survey-Family Functioning Sub-scale
6-month Follow-up
5.4 units on a scale
Interval 1.0 to 7.0
5.2 units on a scale
Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
SafeCare
n=191 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=93 Participants
Child welfare services as usual
Brief Symptom Inventory-Significant Case Percentage
Baseline
80 Participants
40 Participants
Brief Symptom Inventory-Significant Case Percentage
6-month Follow-up
36 Participants
23 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=191 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=93 Participants
Child welfare services as usual
BSI-Global Severity Index
Baseline
0.35 units on a scale
Interval 0.0 to 3.54
0.42 units on a scale
Interval 0.0 to 3.21
BSI-Global Severity Index
6-month Follow-up
0.25 units on a scale
Interval 0.0 to 3.38
0.37 units on a scale
Interval 0.0 to 3.17

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=157 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=71 Participants
Child welfare services as usual
Devereaux Early Child Assessment-Initiative Sub-scale
Baseline
54.92 units on a scale
Standard Deviation 11.62
54.97 units on a scale
Standard Deviation 11.80
Devereaux Early Child Assessment-Initiative Sub-scale
6-month Follow-up
55.44 units on a scale
Standard Deviation 11.20
55.84 units on a scale
Standard Deviation 10.34

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=166 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=73 Participants
Child welfare services as usual
Devereaux Early Child Assessment-Attachment Sub-scale
Baseline
52.4 units on a scale
Standard Deviation 12.0
53.4 units on a scale
Standard Deviation 12.16
Devereaux Early Child Assessment-Attachment Sub-scale
6-month Follow-up
53.8 units on a scale
Standard Deviation 12.0
56.3 units on a scale
Standard Deviation 11.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=190 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=93 Participants
Child welfare services as usual
Mother-Child Neglect Scale (MCNS)
Baseline
3.68 units on a scale
Interval 1.2 to 3.95
3.64 units on a scale
Interval 2.64 to 3.86
Mother-Child Neglect Scale (MCNS)
6-month Follow-up
3.71 units on a scale
Interval 2.73 to 3.95
3.67 units on a scale
Interval 2.64 to 3.95

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=188 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=91 Participants
Child welfare services as usual
Confusion, Hubbub, and Order Scale (CHAOS)
Baseline
1.47 units on a scale
Interval 1.0 to 2.73
1.47 units on a scale
Interval 1.0 to 2.5
Confusion, Hubbub, and Order Scale (CHAOS)
6-month Follow-up
1.53 units on a scale
Interval 1.0 to 2.4
1.47 units on a scale
Interval 1.0 to 2.6

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
SafeCare
n=190 Participants
SafeCare, an evidence-based home visiting program
Supportive Case Management
n=92 Participants
Child welfare services as usual
Family Resources Scale - Revised
Baseline
9.0 units on a scale
Interval 0.0 to 37.0
9.0 units on a scale
Interval 0.0 to 40.0
Family Resources Scale - Revised
6-month Follow-up
8.0 units on a scale
Interval 0.0 to 39.0
6.5 units on a scale
Interval 0.0 to 40.0

Adverse Events

SafeCare

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Supportive Case Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Whitaker

Georgia State University

Phone: 404-413-1282

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place