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Completed

NCT Number: NCT02857673

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CAPPS

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.

Primary outcomes

  1. Referral to Child Protective Services for neglect

    Time frame: Up to 12 months after enrollment in study

    This will be determined using chart review and parent report.

  2. Adherence to recommended medical care

    Time frame: Up to 12 months after enrollment in study

    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.

Secondary outcomes

  1. Parental resilience and social connections - CHIP

    Time frame: Up to 12 months after enrollment in study

    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, α=0.79; psychological stability, α=0.79; and understanding the child's medical situation, α=0.71) within which total mean scores are calculated.

  2. Parental resilience and social connections - PM

    Time frame: Up to 12 months after enrollment in study

    The Pearlin Mastery Scale (PM) measures the degree to which individuals perceive themselves as in control of their lives.

  3. Parental resilience and social connections - RSES

    Time frame: Up to 12 months after enrollment in study

    Rosenberg Self-esteem Scale (RSES).

  4. Parental resilience and social connections - PSS

    Time frame: Up to 12 months after enrollment in study

    Perceived Stress Scale (PSS) - Stress domains include unpredictability, lack of control, burden overload, and stressful circumstances. Reliability studies show Cronbach α's of 0.78 -0.86. The PSS correlates with inventories of burnout & somatization.

  5. Parental resilience and social connections - PSI

    Time frame: Up to 12 months after enrollment in study

    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 α for the parent domain is 0.93 and the test-retest coefficient is 0.96.

  6. Parental resilience and social connections - SAS-SR

    Time frame: Up to 12 months after enrollment in study

    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 (α=0.74) and test-retest reliability (r=0.80). It is sensitive to change in depressed patients undergoing treatment.

  7. Parental resilience and social connections - MOS-SS

    Time frame: Up to 12 months after enrollment in study

    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 (α's > 0.91).

  8. Access to concrete support

    Time frame: Up to 12 months after enrollment in study

    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.

  9. Knowledge of parenting skills, child development - PS

    Time frame: Up to 12 months after enrollment in study

    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 (α = 0.78-0.85) and test-retest reliability.

  10. Knowledge of parenting skills, child development - CTSPC

    Time frame: Up to 12 months after enrollment in study

    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.

Other outcomes

  1. Problem solving skills

    Time frame: Up to 12 months after enrollment in study

    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.

  2. Depression symptoms

    Time frame: Up to 12 months after enrollment in study

    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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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