ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02549287
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Daniel Whitaker, Georgia State University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 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 : September 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

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 Name: Services as Usual




Primary Outcome Measures :
  1. Individual qualitative interview to assess outer- and inner-context factors influencing implementation of SafeCare [ Time Frame: Interviewed once during year two of study. ]
    Qualitative semi-structured interviews with program administrators and supervisors responsible for implementing SafeCare.

  2. Focus-groups to assess outer- and inner-context factors influencing implementation of SafeCare [ Time Frame: Interviewed once during year two of study. ]
    Qualitative semi-structured focus groups with frontline staff responsible for implementing the SafeCare.


Secondary Outcome Measures :
  1. Individual qualitative phone interviews to assess parent perceptions of in-home parenting services. [ Time Frame: Families completed up to two phone interviews throughout their enrollment in the study (I.e., Baseline and approximately 6-months later). ]
  2. Quantitative surveys to assess parent perceptions of in-home parenting services. [ Time Frame: Families completed up to 20 quantitative surveys during each session they had with their provider throughout their enrollment in the study (Approximately 6 months). ]
  3. Quantitative surveys to assess provider perceptions of in-home parenting services. [ Time Frame: Families completed up to 20 surveys during each session they had with their provider and a subset completed two interviews throughout their enrollment in the study. ]

Other Outcome Measures:
  1. Safety Scan to measure home hazards [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    Accessible and unsecured hazards were counted in three rooms in the caregiver's residence.

  2. Parenting Young Children Scale [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The Parenting Young Children Scale is a 21-item scale that assesses three dimensions of positive parenting: limit setting, proactive parenting, and supporting positive behavior. Each subscale score is generated by calculating a mean of seven items on a 7-point scale. Higher scores represent higher degree of positive parenting skills.

  3. 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 and, 2) approximately 6-months later. ]
    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. A total score generated by calculating a mean of the 22 items rated on a 1-4 scale. Lower scores indicate less neglectful behaviors.

  4. 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 and, 2) approximately 6-months later. ]
    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. A total score generated by calculating a mean of all 36 items on a 5-point scale. Each subscale score is by calculating a mean of its 12 associated items (parental distress: lower scores represent less distress; dysfunctional interactions: lower scores represent more dysfunction; and stressors related to having a difficult child: lower scores represent more stress).

  5. Protective Factors survey [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The Protective Factors survey is a 20-item scale that measures multiple concrete protective factors against child abuse and neglect across five subscales. The 'Family Functioning' sub-scale score is by calculating a mean of five items on a 1-7 scale. The 'Social Support' sub-scale score is by calculating a mean of three items on a 1-7 scale. The 'Concrete Support' sub-scale score is by calculating a mean of 3 items on a 1-7 scale. The 'Nurturing' sub-scale score is by calculating a mean of 4 items on a 1-7 scale. The 'Parent knowledge of development' sub-scale score is by calculating a mean of 5 items on a 1-7 scale. Higher scores indicate higher protective factors.

  6. 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 and, 2) approximately 6-months later. ]
    The CHAOS scale (Confusion, Hubbub, and Order) is a 15-item scale that will be used to measure structure and chaos in the home environment, a common well-being related goal among parents. A total score generated by calculating a mean of all 15 items on a 3-point scale; lower scores indicate less chaos.

  7. Brief Symptom Inventory [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    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. SF-12 Health Survey [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The SF-12 Health survey is a brief 12-item scale assessing physical and emotional health with higher scores indicating better health.

  9. Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The ASSIST is a 8-item scale that measures drug and alcohol use and drug/alcohol related problems. For each substance, a score is generated by calculating ratings from each of the 8 items. Higher scores indicates higher reported use of each substance.

  10. Conflict Tactics Scale II [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The Conflict Tactics Scale II is a 20-item scale that to measures relationship violence victimization and perpetration across five subscales. The 'Psychological violence' subscale score is generated using 15 items. The 'Physical violence' subscale score is generated using 12 items. The 'Sexual violence' subscale score is generated using 7 items. The 'Injury from violence' subscale score is generated using 6 items. Higher scores indicate more violence experienced.

  11. 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 and, 2) approximately 6-months later. ]
    The Family Resources Scale - Revised is a 43-item scale that assesses the adequacy of family needs in four domains: basic needs, money, time for self, time for family. Items are rated on a 5-point scale with lower rating indicating a lack of needs. An average need can be generated by calculating a mean of 41 of the items. In addition, a count a resources needed can also be generated.

  12. Injury and Supervision Questionnaire [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The Injury and Supervision Questionnaire is a 17-item scale that contains two subscales: parental supervision and child. The Parental Supervision subscale is scored by generating a mean of 6 items on a 5-point scale with higher scores representing greater reports of parental supervision. A total count child injuries is generated by summing the number of injuries reported as indicated across 11 items.

  13. Devereaux Early Child Assessment (DECA) [ Time Frame: Families were assessed at two time points: 1) after being invited into the study during a visit with their provider and, 2) approximately 6-months later. ]
    The Devereaux Early Child Assessment (DECA) is a 37-item validated behavioral rating scale that assesses child behavior in the domains of initiative, self-control, and behavioral concerns. Each subscale score is generated by summing a total of 7-18 items with higher ratings representing a higher degree of functioning.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549287


Locations
United States, Iowa
Southwest Iowa Family Access Center
Council Bluffs, Iowa, United States, 51301
Children & Families of Iowa
Des Moines, Iowa, United States, 50314
Mid Iowa Family Therapy Center
Des Moines, Iowa, United States, 50324
Four Oaks
Iowa City, Iowa, United States, 50644
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

Responsible Party: Daniel Whitaker, Faculty Sponsor Investigator, Georgia State University
ClinicalTrials.gov Identifier: NCT02549287     History of Changes
Other Study ID Numbers: CER-1409-21178
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018