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

Child Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857673
• Other study ID #: H-35533
• Secondary ID: R01CE002820-01
• Status: Completed
• Phase: N/A
• Start date: February 8, 2016
• Est. completion date: October 5, 2020

Study information

• Verified date: November 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse

Intervention

Behavioral:
• Child Abuse Prevention Problem Solving
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.
• Active Control Group
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Problem solving skills	Problem solving skills will be measured using the Social Problem Solving Inventory -Revised (SPSI-R). This 25 item instrument measures problem orientation and problem-solving skills in 5 dimensions: positive and negative orientation; avoidance; impulsivity; and rationality. The SPSI-R was validated with a diverse community sample and norms exist for adolescents and young adults. It is highly correlated with mood among caregivers of children with disabilities. Subscale internal consistency scores range from 0.76-0.92; test-retest reliability is reported in the range of 0.72-0.88.	Up to 12 months after enrollment in study
Other	Depression symptoms	We will measure caregiver depression using the Quick Inventory of Depressive Symptomatology (QIDS) - Because the QIDS has a wide scoring range, it can be used to detect depressive illness in populations with moderate and low-level symptoms.	Up to 12 months after enrollment in study
Primary	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
Primary	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	Parental resilience and social connections - CHIP	The Coping Health Inventory for Parents (CHIP) is a valid and reliable 45-item instrument designed to measure parents' response to managing family life when they have an ill child. It comprises three subscales (family integration, a=0.79; psychological stability, a=0.79; and understanding the child's medical situation, a=0.71) within which total mean scores are calculated.	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - PM	The Pearlin Mastery Scale (PM) measures the degree to which individuals perceive themselves as in control of their lives.	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - RSES	Rosenberg Self-esteem Scale (RSES).	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - PSS	Perceived Stress Scale (PSS) - Stress domains include unpredictability, lack of control, burden overload, and stressful circumstances. Reliability studies show Cronbach a's of 0.78 -0.86. The PSS correlates with inventories of burnout & somatization.	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - PSI	Parenting Stress - Short Form (PSI) - The PSI assesses a wide range of parenting behaviors in a single instrument, including attachment to child, social isolation, competence, relationship with spouse, and parental health. Cronbach's a for the parent domain is 0.93 and the test-retest coefficient is 0.96.	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - SAS-SR	Social Adjustment Scale Self-Report (SAS-SR) - We will use the SAS-SR, which examines social and role functioning in six areas: work; social activities; relationships with family; spouse or partner; parent; member of family unit. The SAS has high internal consistency (a=0.74) and test-retest reliability (r=0.80). It is sensitive to change in depressed patients undergoing treatment.	Up to 12 months after enrollment in study
Secondary	Parental resilience and social connections - MOS-SS	Medical Outcomes Survey Social Support (MOS-SS) - This tool comprises 4 functional support scales (emotional/informational, tangible, affectionate, and positive interaction) and an overall social support index. Subscales are reliable (a's > 0.91).	Up to 12 months after enrollment in study
Secondary	Access to concrete support	This will be measured using the WE-CARE survey. The survey consists of 14 questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language) and has been tested previously with low-income parents in the clinic setting.	Up to 12 months after enrollment in study
Secondary	Knowledge of parenting skills, child development - PS	Parenting Scale (PS) - The parenting scale is a 30-item questionnaire that measures parenting practices and consistency around discipline, with a focus on dysfunctional discipline: laxness, over-reactivity, and hostility. The scale has good internal consistency (a = 0.78-0.85) and test-retest reliability.	Up to 12 months after enrollment in study
Secondary	Knowledge of parenting skills, child development - CTSPC	Parent-Child Conflict Tactics Scale (CTSPC) - This measure contains 5 subscales that look at different types of discipline. The measure has been validated and is used extensively in the child maltreatment literature.	Up to 12 months after enrollment in study