Clinical trial NCT02857673: A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families
Official title: A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Keywords: Children with Special Health Care Needs
Violence Prevention
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-08-05
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Child maltreatment, particularly neglect, disproportionally affects low-income children with special health care needs (CSHCN) and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. Child Abuse Prevention Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children. This study is a multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child neglect, adherence to recommended medical care, and family stressors and strengths.

Detailed description: Child maltreatment, particularly neglect, disproportionally affects low-income CSHCN and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. CAPPS, a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children.

This is a multi-center randomized controlled efficacy trial of Child Abuse Prevention Problem Solving (CAPPS), a targeted intervention designed to address specific stressors faced by low-income parents of children with special health care needs (CSHCN) and to enhance family strengths previously been shown to reduce the risk of maltreatment. The study will enroll 250 parents of CSHCN who receive primary care in a network of urban patient-centered medical homes. The specific research aims are to 1: Decrease referrals to child protective services for neglect and increase adherence to recommended medical care; and 2: Decrease perceived social isolation, difficulty navigating complex services, and caregiver burden and enhance family strengths, including parental resilience, social connections, access to support in times of need, and knowledge of parenting and child development.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver of a child under age 7 with a physical, emotional, or behavioral health condition
* Child on Medicaid
* Fluent in English or Spanish

Exclusion Criteria:

* Prior history of substantiated child maltreatment
* Prior history of report to child protective services for suspected child maltreatment
* Parent cognitively limited

Primary outcomes:
measure: Referral to Child Protective Services for neglect
timeFrame: Up to 12 months after enrollment in study
measure: Adherence to recommended medical care
timeFrame: Up to 12 months after enrollment in study
Secondary outcomes:
measure: Parental resilience and social connections - CHIP
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - PM
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - RSES
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - PSS
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - PSI
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - SAS-SR
timeFrame: Up to 12 months after enrollment in study
measure: Parental resilience and social connections - MOS-SS
timeFrame: Up to 12 months after enrollment in study
measure: Access to concrete support
timeFrame: Up to 12 months after enrollment in study
measure: Knowledge of parenting skills, child development - PS
timeFrame: Up to 12 months after enrollment in study
measure: Knowledge of parenting skills, child development - CTSPC
timeFrame: Up to 12 months after enrollment in study
Other outcomes:
measure: Problem solving skills
timeFrame: Up to 12 months after enrollment in study
measure: Depression symptoms
timeFrame: Up to 12 months after enrollment in study
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Caroline J Kistin, MD
role: PRINCIPAL_INVESTIGATOR
References: