Child MaltreatmentNCT02549287
Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden
A study testing SafeCare and Supportive Case Management in people with Child Maltreatment, run by Daniel Whitaker at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- SafeCare and Supportive Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2015to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Southwest Iowa Family Access Center
Council Bluffs, Iowa, 51301
Children & Families of Iowa
Des Moines, Iowa, 50314
Mid Iowa Family Therapy Center
Des Moines, Iowa, 50324
Four Oaks
Iowa City, Iowa, 50644
Families First
Waterloo, Iowa, 50701
About this study
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.
Read the 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.
- Conditions
- Child Maltreatment
- Being tested
- SafeCare, Supportive Case Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeCareBehavioural
An evidence-based home visiting program
Supportive Case ManagementBehavioural
Also called Services as Usual
Child welfare services as usual
| Study group | Role | What they receive |
|---|---|---|
| SafeCare | Experimental | SafeCare, an evidence-based home visiting program Receives: Behavioral: SafeCare |
| Supportive Case Management | Active comparator | Child welfare services as usual Receives: Behavioral: Supportive Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
The Supporting Positive Behavior sub-scale of the Parenting Young Children Scale is made up of 7 items that assess supporting positive behavior (Example question: "Notice and praise your child's good behavior"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=125) and participants rating higher than 6 were rated as high (n=159).
Measured: 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 Young Children Scale-Proactive Parenting Sub-scale
The Proactive Parenting sub-scale of the Parenting Young Children Scale is made up of 7 items that assess proactive parenting (Example question: "Avoid struggles with your child by giving clear choices"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=148) and participants rating higher than 6 were rated as high (n=136).
Measured: 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 Young Children Scale-Setting Limits Sub-scale
The Setting limits sub-scale of the Parenting Young Children Scale is made up of 7 items that assess limit setting (Example question: "Stick to your rules and not change your mind"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6.3 or below were rated as low (n=141) and participants rating higher than 6.3 were rated as high (n=143).
Measured: 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
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).
Measured: 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).
Protective Factors Survey-Parent Knowledge Sub-scale
The Parent knowledge sub-scale of the Protective Factors is made up of 5 items that assess parent knowledge. (Example question: "There are many times when I don't know what to do as a parent"). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 3.4-7.0. Higher scores indicate higher parent knowledge. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 7 were rated as low (n=149) and participants rating 7 and higher were rated as high (n=133).
Measured: 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).
Protective Factors Survey-Family Functioning Sub-scale
The Family Functioning sub-scale of the Protective Factors is made up of 5 items that assess family functioning. (Example question: "My family pulls together when things are stressful"). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores indicate higher family functioning. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 6 were rated as low (n=146) and participants rating 6 and higher were rated as high (n=133).
Measured: 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).
Brief Symptom Inventory-Significant Case Percentage
The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: "How much were you distressed by nervousness or shakiness inside"). The 'significant case' definition from the BSI was used and includes those with elevated scores (higher than 2) on any of the subscales. The percentage of participants that were considered a 'significant case' is reports. The 'case' definition from the BSI, which includes elevation on any of the subscale. The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. A total score or the, Global Severity Index, is generated by calculating a mean of all 53 items; lower scores indicate lower levels of distress.
Measured: 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).
BSI-Global Severity Index
The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: "How much were you distressed by nervousness or shakiness inside"). The Global Severity Index calculated a mean of all of the BSI subscales which includes 53 items on a 5-point scale (0=Not at all-4=Extremely). Theoretical range of means: 0-4; Actual range of means: 0.0-3.5). Higher scores indicate higher existence of symptoms. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, females scoring below .77 and males scoring below .57 were rated as low (n=197) and females rating .78 and higher and males rating .58 and higher were rated as high (n=87).
Measured: 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).
Devereaux Early Child Assessment-Initiative Sub-scale
The Initiative sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 11-18 items (depending on child's age) that assesses the child's initiative behavior. (Example question: "Did the child do things for himself"). This subscale score generates a t-score of standardized norms from a sum of the 11-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child initiation. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 56 were rated as low (n=110) and participants rating 56 and higher were rated as high (n=118).
Measured: 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).
Devereaux Early Child Assessment-Attachment Sub-scale
The Attachment sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 8-18 items (depending on child's age) that assesses the child's attachment behavior. (Example question: "Did the toddler accept comfort from a familiar adult"). This subscale score generates a t-score of standardized norms from a sum of the 8-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child attachment. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 52 were rated as low (n=101) and participants rating 52 and higher were rated as high (n=138).
Measured: 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).
Secondary outcomes (3)
Mother-Child Neglect Scale (MCNS)
The Mother-Child Neglect Scale (MCNS) is a 22-item scale designed to assess caregiving behaviors in four domains: physical, cognitive, supervision, and emotional needs. (Example question: "I make sure my child sees a doctor when he/she needs one"). A total score generated by calculating a mean of the 22 items rated on a 4-point scale (1=Strongly Agree - 4=Strongly Disagree). Theoretical range of means: 1-4; Actual range of means: 1.2-3.9. Lower scores indicate less neglectful behaviors. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 3.65 and below were rated as low (n=139) and participants rating higher than 3.65 were rated as high (n=145).
Measured: 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).
Confusion, Hubbub, and Order Scale (CHAOS)
The CHAOS scale (Confusion, Hubbub, and Order) is a 15-item scale used to measure structure and chaos in the home environment. (Example question: "There is very little commotion in our home"). A total score generated by calculating a mean of all 15 items on a 4-point scale (1=Very much like your own home - 4=Not at all like your own home). Theoretical range of means: 1-4; Actual range of means: 1.0-2.7. Lower scores indicate less chaos. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 1.5 or below were rated as low (n=151) and participants rating higher than 1.5 were rated as high (n=133).
Measured: 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).
Family Resources Scale - Revised
The Family Resources Scale - Revised is a 40-item scale that assesses the adequacy of family needs in four domains: basic needs, money, time for self, and time for family. (Example question: "How well is the following need being met: House or apartment"). A total count of resources needed out of 40 assessed. Resources were considered needed if the participant indicated the resource was 'Not at all' met, 'A little' met, or 'Sometimes' met (5-point scale: 1=Not at all - 5=Almost always). Theoretical range of means: 0-40; Actual range of means: 0-40. Higher ratings indicating a higher number of resources needed. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants with 9 or fewer needs not met were rated as low (n=152) and participants with 10 and higher needs not met were rated as high (n=132).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Whitaker
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Daniel Whitaker, Georgia State University
- Investigators
- Daniel J Whitaker, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549287
- Sponsor's protocol ID
- 90CU0062
- Status last verified
- Dec 2019
- First submitted
- 27 Aug 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Whitaker DJ, Self-Brown S, Hayat MJ, Osborne MC, Weeks EA, Reidy DE, Lyons M. Effect of the SafeCare(c) intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial. Prev Med. 2020 Sep;138:106167. doi: 10.1016/j.ypmed.2020.106167. Epub 2020 Jun 20.
PubMed 32569643
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden
- ClinicalTrials.gov ID
- NCT02549287
- Acronym / sponsor ID
- 90CU0062
- Conditions
- Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Daniel WhitakerUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In child welfare services, structured behavioral parenting programs have been documented to reduce important child-welfare outcomes, including child maltreatment recidivism.1-3 In this study, we attempt to learn which factors impacted implementation of an evidence-based practice (EBP) in a diversity of child-welfare serving sites and systems. The primary aim of this study was to identify and assess barriers and facilitators of implementation of a structured behavioral parenting program (SC). We utilized a qualitative research strategy that included semi-structured interviews and focus groups with several levels of staff responsible for implementing the model: program administrators, supervisors, and frontline staff (providers). Our second aim was to understand parent and provider reactions to SafeCare (SC) services and Supportive Case Management (SCM), especially parents' perceptions related to trajectory of burden, engagement, satisfaction, and perceived impact across intervention receipt. We employed mixed methods (both quantitative and qualitative data collection) to inform this question. Specifically, we (1) conducted qualitative interviews with families at two time points during the course of service, (2) collected session-by-session ratings from families on service reaction (perceived burden satisfaction, perceived effectiveness) and providers on family engagement, and (3) collected organizational environment surveys from providers at two time points. The final aim of this study wass to examine the short-term impact of SC versus SCM on client-centered outcomes. Quantitative surveys collected in the family's home at the beginning and end of services measured parenting variables, parent mental health and well-being, and child behavioral, social, and emotional well-being.
Detailed description
The study design was a cluster randomized trial, with randomization occurring at the team level within each study site. We randomized providers within each site to be trained in SafeCare (n = 96) or to continue to deliver SCM (n = 96) which allowed us to control for site differences. From a statistical power perspective, it would have been preferable to randomize clients to interventions, but the fact that teams at community-based organizations typically served a defined geographic area would have meant that home visitors within each team would have had to deliver two distinct interventions raising the likelihood of cross-contamination which, in our experience, would have not been well managed by the study. Providers that were randomized were invited to participate in the study by completing a survey at baseline and 1-year follow-up which included measures of demographics, work experience, organizational factors (culture, climate, leadership) and individual attitudes and beliefs that may affect implementation and service quality. We recruited caregivers into the research study that were receiving services from randomized providers. Measurement of client-level outcomes were collected at baseline and 6-month follow up, as well as during service provision. Both quantitative and qualitative data were collected to capture both breadth and depth of family outcomes and experiences of the interventions.74 By focusing on measures of well-being, this study holds potential to expand the way in which the program effectiveness is conceptualized. This could be particularly important for dissemination of parenting programs to at-risk parents, who may be interested in different outcomes (e.g., improving their child's behavior) than child welfare systems, and findings may be useful for making interventions more appealing to consumers. To measure barriers and facilitators to implementing an evidence-based practice (EBP), we used a qualitative research strategy that included semi-structured interviews and focus groups with several levels of staff, responsible for implementing the model: program administrators, supervisors, and frontline staff (providers). This strategy would yield insight into an array of stakeholder perspectives concerning implementation. In contrast to most implementation studies, ours is the first to conduct a complementary set of interviews and focus groups with staff who have not been trained in SC, the SCM providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SafeCare | Experimental | Behavioral: SafeCareSafeCare, an evidence-based home visiting program |
| Supportive Case Management | Active comparator | Behavioral: Supportive Case ManagementChild welfare services as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeCareAn evidence-based home visiting program | Behavioural | SafeCare |
| Supportive Case ManagementAlso: Services as UsualChild welfare services as usual | Behavioural | Supportive Case Management |
Primary outcome
Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
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).
The Supporting Positive Behavior sub-scale of the Parenting Young Children Scale is made up of 7 items that assess supporting positive behavior (Example question: "Notice and praise your child's good behavior"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=125) and participants rating higher than 6 were rated as high (n=159).
Parenting Young Children Scale-Proactive Parenting Sub-scale
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).
The Proactive Parenting sub-scale of the Parenting Young Children Scale is made up of 7 items that assess proactive parenting (Example question: "Avoid struggles with your child by giving clear choices"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=148) and participants rating higher than 6 were rated as high (n=136).
Parenting Young Children Scale-Setting Limits Sub-scale
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).
The Setting limits sub-scale of the Parenting Young Children Scale is made up of 7 items that assess limit setting (Example question: "Stick to your rules and not change your mind"). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6.3 or below were rated as low (n=141) and participants rating higher than 6.3 were rated as high (n=143).
Parenting Stress Inventory - Short Form
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).
Parenting Stress Inventory - short form is a 36-item scale designed to measure stressors in parenthood including parental distress, dysfunctional interactions, and stressors related to having a difficult child. (Example question: "Sometimes I feel like my child doesn't like me and doesn't want to be close to me"). A total score generated by summing all 36 items on a 5-point scale (1=Strongly Agree - 5=Strongly Disagree). Theoretical total range: 36-180; Actual total range: 38-146. Lower scores represent more stress/dysfunction. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 71 or below were rated as low (n=136) and participants rating higher than 71 were rated as high (n=148).
Protective Factors Survey-Parent Knowledge Sub-scale
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).
The Parent knowledge sub-scale of the Protective Factors is made up of 5 items that assess parent knowledge. (Example question: "There are many times when I don't know what to do as a parent"). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 3.4-7.0. Higher scores indicate higher parent knowledge. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 7 were rated as low (n=149) and participants rating 7 and higher were rated as high (n=133).
Protective Factors Survey-Family Functioning Sub-scale
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).
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).
Brief Symptom Inventory-Significant Case Percentage
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).
The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: "How much were you distressed by nervousness or shakiness inside"). The 'significant case' definition from the BSI was used and includes those with elevated scores (higher than 2) on any of the subscales. The percentage of participants that were considered a 'significant case' is reports. The 'case' definition from the BSI, which includes elevation on any of the subscale. The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. A total score or the, Global Severity Index, is generated by calculating a mean of all 53 items; lower scores indicate lower levels of distress.
BSI-Global Severity Index
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).
The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: "How much were you distressed by nervousness or shakiness inside"). The Global Severity Index calculated a mean of all of the BSI subscales which includes 53 items on a 5-point scale (0=Not at all-4=Extremely). Theoretical range of means: 0-4; Actual range of means: 0.0-3.5). Higher scores indicate higher existence of symptoms. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, females scoring below .77 and males scoring below .57 were rated as low (n=197) and females rating .78 and higher and males rating .58 and higher were rated as high (n=87).
Devereaux Early Child Assessment-Initiative Sub-scale
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).
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).
Devereaux Early Child Assessment-Attachment Sub-scale
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).
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).
3 secondary outcomes
Mother-Child Neglect Scale (MCNS)
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).
Confusion, Hubbub, and Order Scale (CHAOS)
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).
Family Resources Scale - Revised
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32569643Whitaker DJ, Self-Brown S, Hayat MJ, Osborne MC, Weeks EA, Reidy DE, Lyons M. Effect of the SafeCare(c) intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial. Prev Med. 2020 Sep;138:106167. doi: 10.1016/j.ypmed.2020.106167. Epub 2020 Jun 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Whitaker, PhD principal investigator
Georgia State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeCare and Supportive Case Management in people with Child Maltreatment, run by Daniel Whitaker at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Young Children Scale-Supporting Positive Behavior Sub-scale (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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.