Social Determinants of HealthFamilyStressNCT03700697
A Clinical Process Support System for Primary Care to Address Family Stress
A study testing Family Stress Module Intervention in people with Social Determinants of Health and Child Abuse, run by Total Child Health, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health, Child Abuse
- What is being tested?
- Family Stress Module Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,630 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 31 Aug 2021
- 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 1 month to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- -Unable to speak and read English.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Total Child Health
Baltimore, Maryland, 21210
Genevieve Vullo, MHS, 508-517-5106, gvullo@chadis.com
Lydia Stewart, MPH, 910-391-2563, lstewart@chadis.com
About this study
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.
Read the detailed description
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. The family stressors assessed include: intimate partner violence (IPV), parental depression, parental stress, food insecurity, parental substance use and harsh punishment of the child. The system is designed to overcome known obstacles to addressing these issues during routine well child visits. These obstacles include: lack of PCP training in an evidence-based approach to the interview (e.g., motivational interviewing); lack of time; low parental expectations for addressing sensitive family issues during routine child "physicals"; and the usual absence of co-located mental health providers. The new Family Stress module will build on two foundations: 1) previous studies of screening using the Safe Environment for Every Kid (SEEK) tool, which showed reduced child maltreatment outcomes in two Randomized Control Trials; and 2) an existing online screening and decision support system (CHADIS). The goals are to support parents in reducing family risk and the exposure of the young child to their own Adverse Childhood Experiences (ACE), including child maltreatment.
The innovations in this method of addressing family stressors and overcoming the above obstacles include:
- Time efficiencies. Time is saved through pre-visit online data collection, saving both interview and clinical documentation time and staff time saved for patient education and needed referrals.
- Creating the environment for psychosocial care. This is done through a combination of pre-visit questionnaires with agenda broadening questions (best and hardest parts of parenting), inclusion of parental background from Adverse Childhood Experiences (ACE) and Positive Childhood Experiences inquiries in clinical discussions; individualized text and resources for the family in the Care Portal; milestones to "celebrate" in each child's "MemoryBook"; and empathetic and reflective responses from the PCP.
- Efficient training. Training is done using innovative "moment of care" teleprompters created instantly in response to the individual parent issues from the pre-visit tools to support the difficult conversations and a motivational interview begun by the computer needed to move families towards services.
- Care communication. Practices will be able to share data with their own colocated services or be linked electronically with outside local resources using a unique online "consent to share information" functionality that also facilitates determining if the referral appointment was completed. Visit notes and documentation of attendance at a consultation will be shared with consent between the PCP and referral agency or professional to facilitate two-way communication for coordinated care.
Design: A cluster randomized quality improvement intervention using the clinical process support family stress module in routine care for children 0-3 years will be conducted in 30 primary care practices. The project will enroll as many 0-4 month olds as possible and follow them to age 24 months and a cohort of 18-24 month olds as controls using online consent (not requiring staff time). For this 2.5 year project the study staff will ask physicians and office staff to complete a one hour online training, offices to notify parents to complete CHADIS when scheduling well-child visits for children 0-3 years old with the questionnaire assignments for the project including Family Assessment of Safety and Stress (FASS), and primary care clinicians to use the CHADIS Family Stress module including the care coordination functionality during the visits when that site is randomized to the intervention period. At the end of the project the study requires clinicians to complete a survey and provide information from the medical records for participating children about immunization completion and missed visits. This information can be collected in a variety of ways depending on each electronic record.
Outcomes: The outcomes anticipated for the proposed study include improved parent connection to services and parent-child relationships, and reduced family stressors, child behavior problems, harsh punishment, and Child Protection referrals for abuse and neglect. Expected outcomes include that higher parent satisfaction with the enhanced clinical process will result in lower rates of missed visits and delayed immunizations. These results should provide evidence of the effectiveness of PCP screening and referral to reduce family stressors and the evidence needed for full United States Preventive Services Task Force endorsement of this clinical process support tool for reducing child maltreatment.
- Conditions
- Social Determinants of Health, Child Abuse
- Being tested
- Family Stress Module Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Stress Module InterventionBehavioural
as above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Stress Module Intervention |
| Controls | No intervention | Control primary care providers will provide care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: first 2 years of life
Secondary outcomes (6)
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.
Measured: 12 months of child's age (Parent)
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.
Measured: 2 years from first measure (PCP)
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)
Measured: at 2 years of age
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)
Measured: at 2 years of age
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)
Measured: 18 months of age
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)
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start9 Jul 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- 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
- Model description
- A cluster randomized quality improvement intervention trial
- Masking
- None (open label)
- Enrolment
- 16,630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Total Child Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Promotion of Child Development through Primary Care, Foresight Logic
- Responsible party
- Sponsor
- Investigators
- Barbara Howard, MD, Principal investigator, Total Child HealthRaymond Sturner, MD, Principal investigator, Ctr for Promotion of Child Dev. through Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700697
- Sponsor's protocol ID
- R44HD089785
- Other IDs
- R44HD089785
- Acronym
- FamilyStress
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only deidentified data will be available to share. All data will be available to researchers with appropriate interest by arrangement.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Process Support System for Primary Care to Address Family Stress
- ClinicalTrials.gov ID
- NCT03700697
- Acronym / sponsor ID
- FamilyStress / R44HD089785
- Conditions
- Social Determinants of Health, Child Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,630 participants (estimated)
- Lead sponsor
- Total Child Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Promotion of Child Development through Primary Care, Foresight Logic
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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.
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.
Detailed description
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. The family stressors assessed include: intimate partner violence (IPV), parental depression, parental stress, food insecurity, parental substance use and harsh punishment of the child. The system is designed to overcome known obstacles to addressing these issues during routine well child visits. These obstacles include: lack of PCP training in an evidence-based approach to the interview (e.g., motivational interviewing); lack of time; low parental expectations for addressing sensitive family issues during routine child "physicals"; and the usual absence of co-located mental health providers. The new Family Stress module will build on two foundations: 1) previous studies of screening using the Safe Environment for Every Kid (SEEK) tool, which showed reduced child maltreatment outcomes in two Randomized Control Trials; and 2) an existing online screening and decision support system (CHADIS). The goals are to support parents in reducing family risk and the exposure of the young child to their own Adverse Childhood Experiences (ACE), including child maltreatment.
The innovations in this method of addressing family stressors and overcoming the above obstacles include:
- Time efficiencies. Time is saved through pre-visit online data collection, saving both interview and clinical documentation time and staff time saved for patient education and needed referrals.
- Creating the environment for psychosocial care. This is done through a combination of pre-visit questionnaires with agenda broadening questions (best and hardest parts of parenting), inclusion of parental background from Adverse Childhood Experiences (ACE) and Positive Childhood Experiences inquiries in clinical discussions; individualized text and resources for the family in the Care Portal; milestones to "celebrate" in each child's "MemoryBook"; and empathetic and reflective responses from the PCP.
- Efficient training. Training is done using innovative "moment of care" teleprompters created instantly in response to the individual parent issues from the pre-visit tools to support the difficult conversations and a motivational interview begun by the computer needed to move families towards services.
- Care communication. Practices will be able to share data with their own colocated services or be linked electronically with outside local resources using a unique online "consent to share information" functionality that also facilitates determining if the referral appointment was completed. Visit notes and documentation of attendance at a consultation will be shared with consent between the PCP and referral agency or professional to facilitate two-way communication for coordinated care.
Design: A cluster randomized quality improvement intervention using the clinical process support family stress module in routine care for children 0-3 years will be conducted in 30 primary care practices. The project will enroll as many 0-4 month olds as possible and follow them to age 24 months and a cohort of 18-24 month olds as controls using online consent (not requiring staff time). For this 2.5 year project the study staff will ask physicians and office staff to complete a one hour online training, offices to notify parents to complete CHADIS when scheduling well-child visits for children 0-3 years old with the questionnaire assignments for the project including Family Assessment of Safety and Stress (FASS), and primary care clinicians to use the CHADIS Family Stress module including the care coordination functionality during the visits when that site is randomized to the intervention period. At the end of the project the study requires clinicians to complete a survey and provide information from the medical records for participating children about immunization completion and missed visits. This information can be collected in a variety of ways depending on each electronic record.
Outcomes: The outcomes anticipated for the proposed study include improved parent connection to services and parent-child relationships, and reduced family stressors, child behavior problems, harsh punishment, and Child Protection referrals for abuse and neglect. Expected outcomes include that higher parent satisfaction with the enhanced clinical process will result in lower rates of missed visits and delayed immunizations. These results should provide evidence of the effectiveness of PCP screening and referral to reduce family stressors and the evidence needed for full United States Preventive Services Task Force endorsement of this clinical process support tool for reducing child maltreatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized quality improvement intervention trial
| Arm | Type | Receives |
|---|---|---|
| Family Stress Module Intervention | Experimental | Behavioral: Family Stress Module InterventionPrimary 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. |
| Controls | No intervention | –Control primary care providers will provide care as usual. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Unable to speak and read English.
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 |
|---|---|---|
| Family Stress Module Interventionas above | Behavioural | Family Stress Module Intervention |
Primary outcome
Compare intervention vs control percent parents for receiving help for Family Stressors
Time frame: first 2 years of life
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)
Compare intervention vs control percent parents in rates of child maltreatment
Time frame: first 2 years of life
Compare difference between groups in percent with allegations of child maltreatment per state Child Protective Services agency.
Compare intervention vs control percent parents in rates of harsh punishment
Time frame: first 2 years of life
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)
Compare intervention vs control parents in percent reporting child behavior problems
Time frame: first 2 years of life
Compare intervention vs control parents in percent reporting behavior problems per Early Childhood Screening Assessment-short form >=9 (0-44)
Compare intervention vs control percent parents for rate of atypical child development.
Time frame: first 2 years of life
Compare intervention vs control parents in rates of atypical child development as measured by Age \& Stages Questionnaire (monitoring zone or referral zone are atypical)
6 secondary outcomes
Compare parent rating of physician competence and confidence handling family stressors between intervention and control groups
Time frame: 12 months of child's age (Parent)
Change in physician competence and confidence handling family stressors
Time frame: 2 years from first measure (PCP)
Compare intervention vs control group rates of missed well child visits
Time frame: at 2 years of age
Compare intervention vs control group rates of missed recommended immunizations
Time frame: at 2 years of age
Compare intervention vs control group parent-child relationship
Time frame: 18 months of age
Compare intervention vs control group parent-child relationship
Time frame: 24 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: Yes. Only deidentified data will be available to share. All data will be available to researchers with appropriate interest by arrangement.
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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.
Barbara Howard, MD principal investigator
Total Child Health
Raymond Sturner, MD principal investigator
Ctr for Promotion of Child Dev. through Primary Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Stress Module Intervention in people with Social Determinants of Health and Child Abuse, run by Total Child Health, Inc. 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 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Howard, MD (443-618-9104, bhoward@chadis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare intervention vs control percent parents for receiving help for Family Stressors (time frame: first 2 years of life). The study lists 5 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 17 Jul 2020.