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

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ClinicalTrials.gov Identifier: NCT02549287
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Daniel Whitaker, Georgia State University

Brief Summary:

The purpose of this study is to conduct an effectiveness trial of the SafeCare model for parents with substantiated maltreatment. SafeCare, a behavioral parenting program will be compared to supportive case management (SCM), which is a process oriented service aimed at building rapport, providing family support, crisis management, and provision of referrals to additional services. The SafeCare model is a promising intervention for child maltreatment, but has not been broadly compared to usual services across a variety of service setting, and it has not been evaluated with respect to client outcomes of well-being, or service delivery burden, satisfaction, and perceived effectiveness. The study aims are as follows:

(1) Compare SafeCare to SCM on parent and child outcomes including parenting skill, parenting stress and emotional well-being, parent-child relationship, parent and child well-being, and child adaptive behavior. (2) Compare SafeCare to SCM on how families and providers perceive each intervention, specifically with regard to burden, satisfaction, and program impact. (3) Compare SafeCare to SCM on ability to reduce child welfare re-reports. (4) Examine variability in SafeCare effects across sites and client characteristics.


Condition or disease Intervention/treatment Phase
Child Maltreatment Behavioral: SafeCare Behavioral: Supportive Case Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 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
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 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. Change in parenting behaviors as measured by the Parenting Young Children Scale from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This is a survey that assesses three dimensions of positive parenting: limit setting, proactive parenting, and supporting positive behavior.

  2. Change in parent-child relationship/bonding/attachment as measured by the Devereux Early Child Assessment from baseline to 12 months [ Time Frame: Approximately 12 months ]
    The attachment sub-scale of the Devereux Early Child Assessment will be used to assess the quality of the relationship between the parent and the child.

  3. Change in parenting stress as measured by The Parenting Stress Inventory - Short Form from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This 36-item scale is designed to measure stressors in parenthood including parental distress, dysfunctional interactions, and stressors related to having a difficult child.

  4. Change in parent emotional well-being as measured by the Brief Symptom Inventory from baseline to 12 months [ Time Frame: Approximately 12 months ]
    The Brief Symptom Inventory is a 53-item scale is designed to measure a range of emotional health states including depression, anxiety, somatization, and others.

  5. Change in child well-being as measured by the Devereux Early Child Assessment from baseline to 12 months [ Time Frame: Approximately 12 months ]
    The Devereux is a validated behavioral rating scale that assesses child behavior in the domains of initiative, self-control, and behavioral concerns.

  6. Change in parent satisfaction, burden, and perceived program effectiveness as measured by surveys from baseline to 12 months [ Time Frame: Approximately 12 months ]
    Family perceptions of service burden, satisfaction, working alliance, and program effectiveness will be captured by using a survey created by the research team.

  7. Change in parent emotional and physical health as measured by the Short-Form-12 Health Survey from baseline to 12 months [ Time Frame: Approximately 12 months ]
    The Shot-Form-12 is a brief 12-item scale used to assess physical and emotional health.

  8. Change in parent satisfaction, burden, and perceived program effectiveness as measured by qualitative interviews from baseline to 12 months [ Time Frame: Approximately 12 months ]
    Qualitative interviews will be conducted with a small sample of participants (n=48) after services have been completed.


Secondary Outcome Measures :
  1. Change in caregiving behaviors as measured by the Mother-Child Neglect Scale from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This scale is designed to assess caregiving behaviors in four domains: physical, cognitive, supervision, and emotional needs.

  2. Change in home environment as measured by the CHAOS scale (Confusion, Hubbub, and Order) from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This scale measures structure and chaos in the home environment, a common well-being related goal among parents.

  3. Change in family resources as measured by the Family Resource Scale from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This scale assesses the adequacy of family needs in four domains: basic needs, money, time for self, time for family.


Other Outcome Measures:
  1. Change in drug/alcohol use as measured by the ASSIST scale from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This scale measures drug and alcohol use and drug/alcohol related problems.

  2. Change in relationship violence as measured by the short form of the Conflict Tactics Scale II from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This scale will be used to measure relationship violence, victimization, and perpetration.

  3. Change in social support as measured by a sub-scale of the Protective Factors Survey from baseline to 12 months [ Time Frame: Approximately 12 months ]
    This subscale will measure concrete and emotional support.

  4. Change in hazards in the home measured by conducting a home safety scan from baseline to 12 months [ Time Frame: Approximately 12 months ]
    In the home safety scan, assessors will choose three rooms in the house and count the number of accessible hazards in those rooms.



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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


Contacts
Contact: Daniel J Whitaker, PhD 404-413-1282 dwhitaker@gsu.edu
Contact: Colleen M McCarty, MPH 404-413-1294 cmccarty3@gsu.edu

Locations
United States, Iowa
Southwest Iowa Family Access Center Recruiting
Council Bluffs, Iowa, United States
Contact: Rob Berube       rberube100@msn.com   
Children & Families of Iowa Recruiting
Des Moines, Iowa, United States
Contact: Cheryl Johnson       cherylj@cfiowa.org   
Mid Iowa Family Therapy Center Recruiting
Des Moines, Iowa, United States
Contact: Lori Mozena       lmozena@achievements-inc.com   
Four Oaks Recruiting
Iowa City, Iowa, United States
Contact: Mike Mitchell       Mmitchell@fouroaks.org   
Families First Recruiting
Waterloo, Iowa, United States
Contact: Rick Venenga       rvenenga@families-first.net   
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: August 1, 2017
Last Verified: July 2017