Clinical trial NCT02549287: Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden
Official title: Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Maltreatment
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-09-15
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
measure: Parenting Young Children Scale-Supporting Positive Behavior Sub-scale
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).
measure: Parenting Young Children Scale-Proactive Parenting Sub-scale
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).
measure: Parenting Young Children Scale-Setting Limits Sub-scale
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).
measure: Parenting Stress Inventory - Short Form
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).
measure: Protective Factors Survey-Parent Knowledge Sub-scale
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).
measure: Protective Factors Survey-Family Functioning Sub-scale
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).
measure: Brief Symptom Inventory-Significant Case Percentage
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).
measure: BSI-Global Severity Index
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).
measure: Devereaux Early Child Assessment-Initiative Sub-scale
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).
measure: Devereaux Early Child Assessment-Attachment Sub-scale
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).
Secondary outcomes:
measure: Mother-Child Neglect Scale (MCNS)
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).
measure: Confusion, Hubbub, and Order Scale (CHAOS)
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).
measure: Family Resources Scale - Revised
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).
Other outcomes:
Locations:
city: Council Bluffs
country: United States
facility: Southwest Iowa Family Access Center
state: Iowa
city: Des Moines
country: United States
facility: Children & Families of Iowa
state: Iowa
city: Des Moines
country: United States
facility: Mid Iowa Family Therapy Center
state: Iowa
city: Iowa City
country: United States
facility: Four Oaks
state: Iowa
city: Waterloo
country: United States
facility: Families First
state: Iowa
Study officials:
affiliation: Georgia State University
name: Daniel J Whitaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.