Child Abuse Clinical Trial
— FamilyStressOfficial title:
A Clinical Process Support System for Primary Care to Address Family Stress
This project is to create and test a "clinical process support system" that will improve the ability of primary child health care providers (PCPs) to screen for and address family stressors during routine child health visits that are associated with negative child outcomes in a manner that is feasible and acceptable to both clinicians and parents.
Status | Recruiting |
Enrollment | 16630 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 2 Years |
Eligibility |
Inclusion Criteria: - Parents and their children 1 month to 4 months at enrollment. - Parents and their children 16-20 months for comparison group. - Primary Care Providers of any age. Exclusion Criteria: -Unable to speak and read English. |
Country | Name | City | State |
---|---|---|---|
United States | Total Child Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Total Child Health, Inc. | Center for Promotion of Child Development through Primary Care, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Foresight Logic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare intervention vs control percent parents for receiving help for Family Stressors | Compare intervention vs control percent parents endorsing "getting help" with any of: Intimate Partner Violence per Hurt, insulted, Threatened with Harm, Screamed score >=2 (0-40) substance use per NIH measure of excess alcohol or drug use >2 (0-12) depression per Patient Health Questionnaire-2 >=2 (0-4), food insecurity per Hunger Vital Sign >=1 (0-2), life stress per parent report of life stress (yes/no) harsh punishment per by report of hitting or screaming >=1(0-2) |
first 2 years of life | |
Primary | Compare intervention vs control percent parents in rates of child maltreatment | Compare difference between groups in percent with allegations of child maltreatment per state Child Protective Services agency. | first 2 years of life | |
Primary | Compare intervention vs control percent parents in rates of harsh punishment | Compare intervention vs control percent parents for difference between groups in percent with harsh punishment per Conflict Tactics Scale- Parent Child version >0 (0-2) | first 2 years of life | |
Primary | Compare intervention vs control parents in percent reporting child behavior problems | Compare intervention vs control parents in percent reporting behavior problems per Early Childhood Screening Assessment-short form >=9 (0-44) | first 2 years of life | |
Primary | Compare intervention vs control percent parents for rate of atypical child development. | Compare intervention vs control parents in rates of atypical child development as measured by Age & Stages Questionnaire (monitoring zone or referral zone are atypical) | first 2 years of life | |
Secondary | Compare parent rating of physician competence and confidence handling family stressors between intervention and control groups | Compare rating total scores of self reported care and confidence on survey measure using vignettes called Patient View of Healthcare. | 12 months of child's age (Parent) | |
Secondary | Change in physician competence and confidence handling family stressors | Change in total score of ratings of self reported care and confidence on survey measure using vignettes at start and end of project, approximately 2.5 years. | 2 years from first measure (PCP) | |
Secondary | Compare intervention vs control group rates of missed well child visits | Difference between groups in percent of medical record reports of missed well child visits (0-6 visits) | at 2 years of age | |
Secondary | Compare intervention vs control group rates of missed recommended immunizations | Difference between groups in percent of medical record reports of missed recommended routine vaccinations (0-5 episodes) | at 2 years of age | |
Secondary | Compare intervention vs control group parent-child relationship | Difference between groups on total score on Protective Factors Survey of parent ratings of family relationships (0-140) | 18 months of age | |
Secondary | Compare intervention vs control group parent-child relationship | Difference between groups on total score on Protective Factors Survey of parent ratings of family relationships (0-140) | 24 months of age |
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