A Clinical Process Support System for Primary Care to Address Family Stress

NCT03700697 | Unknown DMC

• 1 other identifier: R44HD089785
• Study Type: interventional
• Target: 16,630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Determinants of Health; Child Abuse

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Compare parent rating of physician competence and confidence handling family stressors between intervention and control groups

  12 months of child's age (Parent)

• Change in physician competence and confidence handling family stressors

  2 years from first measure (PCP)

• Compare intervention vs control group rates of missed well child visits

  at 2 years of age

• Compare intervention vs control group rates of missed recommended immunizations

  at 2 years of age

• Compare intervention vs control group parent-child relationship

  18 months of age

Study Arms (2)

Family Stress Module Intervention

EXPERIMENTAL

Primary care clinicians will use the CHADIS Family Stress Module including the reviewing ACE, Positive Childhood Experiences, and FASS Plus questionnaires at designated child ages; address family stressors revealed using the motivational interviewing teleprompter and refer parents with stressors as indicated using the care coordination functionality.

Behavioral: Family Stress Module Intervention

Controls

NO INTERVENTION

Control primary care providers will provide care as usual.

Interventions

Family Stress Module Intervention BEHAVIORAL

as above

Family Stress Module Intervention

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Unable to speak and read English.

Sponsors & Collaborators

• Total Child Health, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Center for Promotion of Child Development through Primary Care: collaborator
• Foresight Logic: collaborator

Study Sites (1)

Total Child Health

Baltimore, Maryland, 21210, United States

RECRUITING

Study Officials

• Barbara Howard, MD

  Total Child Health

  PRINCIPAL INVESTIGATOR

• Raymond Sturner, MD

  Ctr for Promotion of Child Dev. through Primary Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Howard, MD

CONTACT

443-618-9104; bhoward@chadis.com

Genevieve Vullo, MHS

CONTACT

508-517-5106; gvullo@chadis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A cluster randomized quality improvement intervention trial

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: October 9, 2018
• Study Start: July 9, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion and reporting to NIH.
• Access Criteria: Researchers with appropriate interest, by arrangement.

Locations

US (1)