A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families

NCT02857673 | Completed

• 2 other identifiers: H-35533R01CE002820-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Abuse

Keywords

Children with Special Health Care Needs; Violence Prevention

Outcome Measures

Primary Outcomes (2)

• Referral to Child Protective Services for neglect

  This will be determined using chart review and parent report.

  Up to 12 months after enrollment in study

• Adherence to recommended medical care

  Adherence will be evaluated by chart review to determine a composite measure that includes numbers of medical visits attended, hospitalizations, missed appointments, delayed or missed prescriptions fills, and receiving recommended immunizations.

  Up to 12 months after enrollment in study

Secondary Outcomes (10)

• Parental resilience and social connections - CHIP

  Up to 12 months after enrollment in study

• Parental resilience and social connections - PM

  Up to 12 months after enrollment in study

• Parental resilience and social connections - RSES

  Up to 12 months after enrollment in study

• Parental resilience and social connections - PSS

  Up to 12 months after enrollment in study

• Parental resilience and social connections - PSI

  Up to 12 months after enrollment in study

Other Outcomes (2)

• Problem solving skills

  Up to 12 months after enrollment in study

• Depression symptoms

  Up to 12 months after enrollment in study

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive Child Abuse Prevention Problem Solving (CAPPS), a one-on-one, workbook-based intervention of six sessions, each lasting approximately 30-60 minutes. CAPPS is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. Sessions will be delivered at the medical home by bachelor level providers, whose availability and level of training mimic those of existing medical home care coordinators.

Behavioral: Child Abuse Prevention Problem Solving

Active Control Group

ACTIVE COMPARATOR

Parents in both study groups will receive the standard medical and social work services offered in the patient-centered medical homes where their children receive care. In addition, to account for potential surveillance bias, families in the control group will be contacted by a member of the study team six times over 12 weeks, approximating the frequency of contact that the intervention group receives from the CAPPS providers. The study team member will not be trained in CAPPS and will adhere to a case management model consistent with resources available in the medical home, checking in with control families and offering to help identify existing clinic and community resources as needed.

Behavioral: Active Control Group

Interventions

Child Abuse Prevention Problem Solving BEHAVIORAL

The CAPPS intervention includes problem solving, motivational interviewing, and referral to existing services. Intervention providers will conduct three core problem solving sessions and three sessions tailored to the common problems experienced by parents of CSHCN: caregiver burden, difficulties navigating complex medical services, and social isolation. Intervention providers will use their motivational interviewing skills during regular, ongoing interactions with their clients to enhance willingness to participate meaningfully in CAPPS sessions. Referral to existing services in the medical home and in the community will occur as needs arise during CAPPS sessions.

Also known as: CAPPS

Intervention Group

Active Control Group BEHAVIORAL

Parents in both study groups will receive the standard medical and social work services offered in the patient-centered medical homes where their children receive care. In addition, to account for potential surveillance bias, families in the control group will be contacted by a member of the study team six times over 12 weeks, approximating the frequency of contact that the intervention group receives from the CAPPS providers.

Active Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Caroline J Kistin, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 5, 2016
• Study Start: February 8, 2016
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)