Child AbuseNCT02857673
A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families
A study testing Child Abuse Prevention Problem Solving in people with Child Abuse, run by Boston Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Abuse
- What is being tested?
- Child Abuse Prevention Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2016to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary caregiver of a child under age 7 with a physical, emotional, or behavioral health condition
- Child on Medicaid
- Fluent in English or Spanish
Who cannot join
- Prior history of substantiated child maltreatment
- Prior history of report to child protective services for suspected child maltreatment
- Parent cognitively limited
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Child Abuse
- Being tested
- Child Abuse Prevention Problem Solving, Active Control Group
- Keywords
- Children with Special Health Care Needs, Violence Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Abuse Prevention Problem SolvingBehavioural
Also called CAPPS
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral to Child Protective Services for neglect
This will be determined using chart review and parent report.
Measured: 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.
Measured: Up to 12 months after enrollment in study
Secondary outcomes (10)
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, 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.
Measured: Up to 12 months after enrollment in study
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.
Measured: Up to 12 months after enrollment in study
Parental resilience and social connections - RSES
Rosenberg Self-esteem Scale (RSES).
Measured: Up to 12 months after enrollment in study
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 α's of 0.78 -0.86. The PSS correlates with inventories of burnout \& somatization.
Measured: Up to 12 months after enrollment in study
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 α for the parent domain is 0.93 and the test-retest coefficient is 0.96.
Measured: Up to 12 months after enrollment in study
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 (α=0.74) and test-retest reliability (r=0.80). It is sensitive to change in depressed patients undergoing treatment.
Measured: Up to 12 months after enrollment in study
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 (α's > 0.91).
Measured: Up to 12 months after enrollment in study
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.
Measured: Up to 12 months after enrollment in study
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 (α = 0.78-0.85) and test-retest reliability.
Measured: Up to 12 months after enrollment in study
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.
Measured: Up to 12 months after enrollment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start8 Feb 2016
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Caroline J Kistin, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857673
- Sponsor's protocol ID
- H-35533
- Other IDs
- R01CE002820-01
- Status last verified
- Nov 2020
- First submitted
- 3 Aug 2016
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families
- ClinicalTrials.gov ID
- NCT02857673
- Acronym / sponsor ID
- H-35533
- Conditions
- Child Abuse
- Keywords
- Children with Special Health Care Needs, Violence Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Child Abuse Prevention Problem SolvingThe 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. |
| Active Control Group | Active comparator | Behavioral: Active Control GroupParents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary caregiver of a child under age 7 with a physical, emotional, or behavioral health condition
- Child on Medicaid
- Fluent in English or Spanish
Key exclusion criteria (3 listed)
- Prior history of substantiated child maltreatment
- Prior history of report to child protective services for suspected child maltreatment
- Parent cognitively limited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child Abuse Prevention Problem SolvingAlso: CAPPSThe 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. | Behavioural | Intervention Group |
| Active Control GroupParents 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. | Behavioural | Active Control Group |
Primary outcome
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.
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.
10 secondary outcomes
Parental resilience and social connections - CHIP
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - PM
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - RSES
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - PSS
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - PSI
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - SAS-SR
Time frame: Up to 12 months after enrollment in study
Parental resilience and social connections - MOS-SS
Time frame: Up to 12 months after enrollment in study
Access to concrete support
Time frame: Up to 12 months after enrollment in study
Knowledge of parenting skills, child development - PS
Time frame: Up to 12 months after enrollment in study
Knowledge of parenting skills, child development - CTSPC
Time frame: Up to 12 months after enrollment in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline J Kistin, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Abuse Prevention Problem Solving in people with Child Abuse, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral to Child Protective Services for neglect (time frame: Up to 12 months after enrollment in study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.